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DWK 818061406 DURAN PURE Bottle, amber, GL 25, 25 mL

DWK 818061406 DURAN PURE Bottle, amber, GL 25, 25 mL

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SKU: 818061406 CASE 7 - 10 Business Days
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DURAN® PURE 818061406 Amber Laboratory Bottle - 25 mL, GL 25, Type I Borosilicate Glass 3.3, 10/Case

DURAN® PURE 818061406 Amber Glass Bottles from DWK Life Sciences are 25 mL pharmaceutical and laboratory containers manufactured from Type I borosilicate glass 3.3, with a GL 25 screw-thread finish and durable amber coloration designed to help protect light-sensitive materials.

Developed for the documentation and quality requirements of pharmaceutical and biotechnology production, DURAN PURE bottles combine the chemical and thermal properties of DURAN glass with enhanced manufacturing controls, lot traceability, inspection, and regulatory support. These features make the PURE range particularly relevant for laboratories and manufacturers handling active pharmaceutical ingredients (APIs), drug intermediates, excipients, and sensitive formulations.

The exact 818061406 bottle has a nominal capacity of 25 mL, an outside diameter of 36 mm, and a manufacturer-listed height of 70 mm. Its GL 25 threaded neck accepts appropriately matched closures, which must be selected separately according to the required chemical compatibility and processing conditions.

Amber protection: DWK applies its amber coloration to the exterior surface of Type I borosilicate glass using a thermally fixed process. Its DURAN PURE technical brochure describes a light transmission rate below 10% in the 290-450 nm wavelength range, supporting protection against ultraviolet and selected visible-light exposure. Actual product stability must still be established for the material being stored.

Pharmaceutical quality assurance: DWK specifies 100% visual inspection, single-lot delivery, 100% manufacturing-process traceability, and hydrolytic-resistance analysis according to European, United States, and Japanese pharmacopoeial requirements for each batch. A lot-specific Certificate of Analysis (CoA) is provided, supporting incoming inspection, supplier qualification, and regulated manufacturing documentation.

DURAN PURE also incorporates formal change control and customer notification. DWK identifies a filed FDA Type III Packaging Material Drug Master File (DMF #28042) for the bottle range and a China CDE/NMPA registration number B20220000306. These references support regulatory documentation and do not, by themselves, represent FDA approval of a finished drug product or a specific bottle-and-closure application.

Supplied with a protective dust cover, not a functional screw cap. DURAN PURE bottles are covered after manufacturing to help minimize contamination during storage and transportation. The protective cover is not a qualified long-term liquid-storage closure or a substitute for a GL 25 pharmaceutical screw cap. Functional caps, liners, and seals must be purchased separately.

DWK lists the glass bottle as autoclavable, but the standard supplied product is non-sterile and is not certified particle-free or ready for aseptic use. Any validated cleaning, depyrogenation, sterilization, or filling operation must account for the actual container, separately selected closure, and manufacturing process.

DWK assigns a five-year manufacturer shelf life to DURAN PURE bottles, with the expiry date documented for each manufacturing lot. This dating supports controlled pharmaceutical inventory management and should not be interpreted as an expiration date for contents placed into the bottle.

WHEATON and DURAN bottle alternatives may have similar capacities, but the DURAN PURE quality system, documentation package, glass material, light protection, and GL 25 finish should be evaluated as part of the exact approved product specification. Each manufacturer case of SKU 818061406 contains 10 amber bottles.

Ordering note: Specify DURAN PURE 818061406 for the 25 mL amber Type I borosilicate glass 3.3 bottle with GL 25 thread, 36 mm diameter, 70 mm height, and protective dust cover. Supplied 10 bottles per case with manufacturer lot documentation. A functional GL 25 screw cap is not included. The bottles are autoclavable but supplied non-sterile.

Specifications:
  • Manufacturer: DWK Life Sciences
  • Brand: DURAN® PURE
  • Manufacturer part number: 818061406
  • Product type: Pharmaceutical-grade documentation-supported amber glass laboratory bottle
  • Nominal capacity: 25 mL
  • Material: Borosilicate glass 3.3
  • Glass classification: Type I borosilicate glass
  • Glass color: Amber
  • Color technology: Thermally fixed exterior amber coloration
  • General amber light transmission: Less than 10% from 290-450 nm, per DWK DURAN PURE technical brochure
  • Thread finish: GL 25
  • Outside diameter: 36 mm
  • Manufacturer-listed height: 70 mm
  • Neck style: GL 25 threaded opening
  • Protective cover: Yes, temporary dust cover supplied
  • Functional screw cap: Not included; order separately
  • Case quantity: 10 bottles
  • Purchase unit: Case
  • Autoclavable: Yes, per exact bottle specification
  • Sterility as supplied: Non-sterile
  • Particle-free / ready-to-use certification: Not supplied as standard
  • Manufacturer shelf life: 5 years; verify expiry on the supplied lot
  • Manufacturer quality control: 100% visual inspection
  • Lot presentation: Single-lot delivery
  • Hydrolytic-resistance testing: Batch analysis aligned with EP, USP, and JP requirements
  • Traceability: 100% traceability of manufacturing steps; Retrace Code and lot documentation
  • Certificate of Analysis: Lot-specific CoA provided
  • Change control: Managed manufacturer change notification
  • Glass material standard: ISO 3585 borosilicate 3.3; ASTM E438 Type I, Class A glass classification
  • FDA regulatory reference: Type III Packaging Material DMF #28042 filed for DURAN PURE bottles
  • China regulatory reference: CDE/NMPA B20220000306
  • Related separately sold GL 25 cap: DURAN PURE 891081306, PFA body with PTFE-coated silicone seal, 5 caps per pack
  • Exact graduated scale: Not specified in current exact-SKU data
  • Calibrated volumetric accuracy: Not established
  • Pressure / vacuum rating: Not established for this bottle
  • Validated sterile filling configuration: Requires application-specific qualification
  • Shipping weight and carton dimensions: Not verified
Amber Light Protection for Sensitive Materials

DWK's DURAN PURE amber technology applies a homogeneous, thermally fixed amber color to the exterior surface of Type I borosilicate glass. This provides light protection while preserving the underlying borosilicate glass material at the bottle's interior contact surface.

The manufacturer technical brochure specifies less than 10% light transmission over 290-450 nm, making amber DURAN PURE appropriate for evaluation when compounds require protection from selected UV and visible wavelengths.

This optical statement is a manufacturer product-family specification. It is not a complete spectral transmission curve or a guarantee that every light-sensitive pharmaceutical formulation will remain stable. Storage duration, temperature, illumination, oxygen exposure, container closure, and the specific chemical formulation must all be considered.

Light-protection distinction: DURAN PURE amber bottles are designed to reduce exposure in the manufacturer-specified wavelength range. They are not lightproof across every wavelength and do not replace product-specific photostability testing.

What Makes DURAN PURE Different?

The DURAN PURE designation identifies a product family developed to support pharmaceutical quality systems. Alongside Type I borosilicate glass properties, DWK emphasizes controlled handling, extensive traceability, inspection, and regulatory documentation.

  • 100% visual inspection: Manufacturer inspection of every PURE bottle.
  • Single-lot delivery: Helps support consistent batch documentation and inventory control.
  • Lot-specific CoA: Supports quality review of the actual manufacturing lot.
  • Hydrolytic-resistance testing: Batch analysis with reference to USP, EP, and JP requirements.
  • Manufacturing traceability: Supports documented tracking through production.
  • Change control: Managed changes with customer notification.
  • Protective dust cover: Applied after production to help control exposure during handling and transportation.
  • Regulatory support: DMF references and additional qualification information are available from DWK.
  • Defined manufacturer dating: Five-year shelf life with an expiry date tied to the lot.

These features do not mean the standard bottles are supplied sterile, depyrogenated, certified particle-free, or ready for direct aseptic filling without further qualification.

GL 25 Dust Cover vs. Pharmaceutical Screw Cap

Every standard DURAN PURE bottle is supplied with a temporary protective dust cover intended to help limit contamination of the bottle interior during manufacturing, storage, and transit. It is not a functional liquid-storage, solvent-resistant, or leakproof screw cap.

For a functional closure, select a compatible GL 25 cap and evaluate its body material, seal, chemical resistance, sterilization procedure, and intended application.

DWK separately offers DURAN PURE 891081306, a GL 25 PFA screw cap with a PTFE-coated silicone seal, supplied 5 caps per pack. This is a distinct accessory and is not included in the bottle case.

Purchasing reminder: Ordering one case of 818061406 supplies 10 glass bottles with temporary dust covers, not 10 complete pharmaceutical bottle-and-screw-cap assemblies. Order GL 25 caps separately if the application requires a functional closure.

Type I Borosilicate Glass 3.3: Material Advantages

DURAN PURE uses borosilicate glass 3.3, classified as Type I glass. DWK describes this material as offering high hydrolytic resistance, good chemical durability, and low thermal expansion. These properties support pharmaceutical material-handling applications where glass composition and chemical interaction are important.

The manufacturer identifies borosilicate 3.3 according to ISO 3585 and the ASTM E438 Type I, Class A glass family. Exact lot acceptance should be documented using the supplied CoA, rather than relying only on general material descriptions.

Borosilicate glass is resistant to many common laboratory chemicals, but not universally inert. Hydrofluoric acid, hot concentrated phosphoric acid, and strong alkaline conditions require particular caution. The selected GL 25 cap and seal must also be qualified for any stored substance.

Common Applications:
  • Pharmaceutical development and GMP-aligned manufacturing support
  • Storage of compatible light-sensitive active pharmaceutical ingredients (APIs)
  • Drug intermediates, excipients, and formulation development materials
  • Biotechnology and life-sciences research
  • Pharmaceutical quality control and stability testing
  • Small-volume laboratory and pilot-plant material handling
  • Controlled production environments requiring lot documentation and change control
  • Applications requiring Type I borosilicate glass and amber light protection

The precise use of a PURE bottle in primary packaging, sterile manufacturing, compounding, or material transportation requires qualification of the complete container-closure system and the relevant process. FDA DMF filing and glass-type compliance do not automatically establish suitability for every application.

Best-Practice Receiving, Storage, and Processing
  • Verify the exact SKU: Confirm DURAN PURE 818061406, amber, 25 mL, GL 25.
  • Check case quantity: Verify 10 bottles and their temporary protective covers.
  • Inspect glass: Check the bottle, threads, rim, and exterior amber finish for damage.
  • Review the CoA: Match the product number and manufacturing lot to the supplied documentation.
  • Record expiry: Follow the five-year manufacturer dating and the expiry printed for the supplied lot.
  • Select a functional cap: Order and qualify a separate GL 25 closure for filled-product use.
  • Determine cleanliness requirements: PURE bottles are not supplied sterile or certified particle-free by default.
  • Validate sterilization: The glass bottle is autoclavable, but processing must account for the actual cap and protective-cover removal.
  • Verify chemical compatibility: Evaluate both glass and closure materials against the intended contents.
  • Maintain traceability: Retain batch records, inspection information, and any required validation documentation.
Related DURAN PURE Configurations
  • 818061406: 25 mL amber borosilicate glass bottle, GL 25, 10/case.
  • 818011401: 25 mL clear borosilicate glass bottle, GL 25, 10/case.
  • 818062402: 100 mL amber borosilicate glass bottle, GL 45, 10/case.
  • 818063604: 250 mL amber borosilicate glass bottle, GL 45, 10/case.
  • 891081306: Separately sold DURAN PURE GL 25 premium screw cap, PFA with PTFE-coated silicone seal, 5/pack.

Selection note: The 25 mL bottle uses GL 25, whereas the larger 100 mL and 250 mL amber versions use GL 45. Do not substitute caps based on similar appearance or the DURAN PURE brand alone.

Manufacturer Technical Documentation

These are manufacturer technical, regulatory-information, and certificate resources. No DWK product-shopping or purchasing pages are linked. Lot-specific CoA values and expiry dates must be taken from the certificate for the delivered batch.

Why Order DURAN PURE 818061406 From SOSCleanroom?
  • Exact-SKU sourcing: Specify the correct 25 mL amber GL 25 DURAN PURE configuration.
  • Pharmaceutical documentation support: Request lot-specific CoAs, regulatory information, and manufacturer clarification.
  • Closure coordination: Identify separately sold GL 25 caps and appropriate sealing materials.
  • Application-focused selection: Compare amber and clear DURAN PURE options as well as larger GL 45 sizes.
  • Centralized procurement: Source laboratory glassware and critical-environment consumables through SOSCleanroom.
  • Responsive customer service: Contact SOSCleanroom for pricing, case quantities, availability, and lead times.

Technical note: The Technical Vault provides further information about DURAN PURE Type I glass, amber light protection, pharmaceutical quality documentation, GL 25 closure selection, hydrolytic resistance, and lot-specific shelf life.

For pricing, availability, lot documentation, or GL 25 closures, email Sales@SOSsupply.com or call (214) 340-8574.

Product page updated: October 28, 2026

© 2026 Specialty Optical Systems, Inc. (dba SOSCleanroom). All rights reserved.

The Technical Vault By SOSCleanroom
DURAN PURE 818061406 25 mL Amber Glass Type I Borosilicate 3.3 GL 25 36 x 70 mm CoA Supported Autoclavable Bottle Non-Sterile 10/Case
DURAN PURE 818061406: Exact-SKU Technical Overview

DURAN® PURE 818061406 is a 25 mL amber Type I borosilicate glass 3.3 bottle from DWK Life Sciences, with a GL 25 threaded neck, 36 mm outside diameter, and 70 mm manufacturer-listed height. It is supplied in a case of 10 bottles.

The PURE bottle range is designed for pharmaceutical production, material handling, and documentation-intensive applications. DWK specifies enhanced quality controls including 100% visual inspection, single-lot delivery, lot-specific Certificates of Analysis, full manufacturing traceability, hydrolytic-resistance testing, and formal change-control management.

The amber finish is applied to the exterior of Type I borosilicate glass. DWK's manufacturer brochure reports a light transmission rate below 10% across 290-450 nm, supporting the evaluation of DURAN PURE amber bottles for light-sensitive compounds.

The exact product specification states that the glass bottle is autoclavable. However, DURAN PURE bottles are not supplied sterile, and DWK does not certify the standard bottle as particle-free, depyrogenated, or ready for aseptic filling without further preparation.

A temporary protective dust cover is supplied to help protect the bottle interior during storage and transport. This cover is not a functional pharmaceutical screw cap. A suitable GL 25 closure must be purchased separately when the container will hold a liquid or other material requiring a qualified seal.

Exact ordering configuration: DURAN PURE 818061406, 25 mL amber borosilicate glass 3.3, GL 25, 36 x 70 mm, protective dust cover, 10 bottles per case. The glass bottle is autoclavable but supplied non-sterile. Functional screw caps are sold separately.

Exact Manufacturer Specifications
Specification DWK manufacturer information
ManufacturerDWK Life Sciences
BrandDURAN PURE
Catalog number818061406
Product typeAmber pharmaceutical/laboratory glass bottle
Nominal capacity25 mL
Glass materialDURAN borosilicate glass 3.3
Glass classificationType I
Glass colorAmber
Color applicationThermally fixed exterior amber treatment
General spectral transmissionLess than 10% from 290-450 nm, per DURAN PURE technical brochure
ThreadGL 25
Outside diameter36 mm
Height70 mm
Purchase unitCase
Case quantity10 bottles
Temporary protective coverIncluded
Functional GL 25 screw capNot included; purchase separately
AutoclavabilityYes, exact bottle specification
Sterility as suppliedNon-sterile, per DURAN PURE manufacturer guidance
Particle-free certificationNot supplied as standard
Depyrogenated/ready-to-use statusNot supplied as standard
Quality inspection100% visual inspection
Lot presentationSingle-lot delivery
TraceabilityManufacturing traceability; Retrace Code / lot reference
Certificate of AnalysisLot-specific CoA
Hydrolytic resistanceBatch analysis aligned with EP, USP, JP requirements
Change controlDWK managed change control / customer notification
Manufacturer shelf life5 years; check lot-specific expiry
Glass standardsISO 3585; ASTM E438 Type I, Class A
FDA DMF referenceType III Packaging Material DMF #28042, filed for PURE bottles
China regulatory referenceCDE/NMPA B20220000306
Suggested separately sold capDURAN PURE 891081306; GL 25; PFA/PTFE-coated silicone; 5/pack
Exact graduation intervalNot specified for this SKU
Certified calibrated volumeNot established
Pressure/vacuum certificationNot established
Specific cap-and-bottle leak rateNot established
Actual delivered batch expiryUse the label and CoA for the delivered lot
Shipping weight and carton dimensionsNot confirmed

Specification boundary: The 25 mL capacity is nominal. No exact volumetric calibration tolerance or functional screw-cap seal is included in this bottle's basic specification. Quality documentation describes the manufacturer's glass product; the final filled container and closure still require application-specific qualification.

DURAN PURE vs. Standard Laboratory Bottles

The distinction between DURAN PURE and ordinary laboratory bottles goes beyond the Type I glass formulation. DWK emphasizes a pharmaceutical-oriented combination of controlled production, inspection, traceability, batch documentation, and change management.

DURAN PURE feature Why it matters
100% visual inspectionDocumented manufacturer inspection of each PURE bottle
Single-lot deliverySupports consistent lot records and procurement traceability
Lot-specific CoASupports incoming quality review and qualification
Hydrolytic-resistance analysisProvides batch-level glass performance documentation
Controlled handlingDust cover applied after production to help reduce exposure
Formal change controlSupports review of manufacturer specification/process changes
Regulatory referencesSupports pharmaceutical submission and supplier documentation requirements
Five-year manufacturer datingSupports controlled inventory and expiration management

These enhancements do not imply every standard DURAN bottle lacks quality control. They describe additional documented characteristics DWK associates with the PURE range.

Important distinction: A GMP-aligned product family is not automatically a sterile, ready-to-use, or validated filled-product package. The user's quality system must still determine whether the supplied glass, closure, cleanliness, and processing records meet the intended application requirements.

Amber Glass Technology and Spectral Light Protection

DWK's DURAN PURE amber bottles begin with Type I borosilicate glass 3.3. The amber color is applied on the exterior glass surface and thermally fixed. This creates a uniform amber layer while maintaining the underlying borosilicate glass material at the interior contact surface.

In its DURAN PURE technical brochure, DWK documents less than 10% light transmission across the 290-450 nm wavelength region and associates this performance with European and United States pharmacopoeial light-transmission requirements.

Characteristic Manufacturer-supported information
Base glassType I borosilicate 3.3
Amber locationExterior surface
Coloring processThermally fixed amber treatment
Documented spectral region290-450 nm
Manufacturer transmission statementLess than 10% across the specified region
Intended benefitProtection of suitable light-sensitive materials
Exact per-lot spectrumNot provided in the standard product listing
Protection at all wavelengthsNot established
Product-specific photostability guaranteeNot established; validate actual formulation

Amber glass is relevant for compounds that are susceptible to photodegradation. However, a light-protective container does not independently establish an acceptable storage period or stability profile. Actual performance depends on the substance, concentration, illumination, temperature, oxygen exposure, fill volume, closure, and storage conditions.

Optical qualification boundary: The manufacturer's documented 290-450 nm performance is valuable for container selection, but it is not a guarantee of full-spectrum opacity, lightproof storage, or successful ICH photostability testing for every formulation.

Type I Borosilicate Glass 3.3: Hydrolytic and Chemical Resistance

DURAN PURE glass belongs to the 3.3 expansion borosilicate glass family, identified by DWK with ISO 3585 and ASTM E438 Type I, Class A. This material is selected for high hydrolytic resistance, low thermal expansion, and broad chemical durability.

DWK's general glass properties documentation describes borosilicate 3.3 as resistant to many aqueous solutions, acids, salts, and organic solvents. However, hydrofluoric acid, hot concentrated phosphoric acid, and strong alkaline solutions can appreciably attack the material. Compatibility must be evaluated for the actual contents and processing conditions.

The DURAN PURE quality program includes hydrolytic-resistance testing for manufacturing batches, using methods aligned with international pharmacopoeial requirements. This supports glass quality review but does not eliminate the need for compatibility evaluation, extractables/leachables assessment, or supplier qualification when required.

Material topic Technical interpretation
Type I glassHigh hydrolytic-resistance glass classification
ISO 3585General borosilicate glass 3.3 reference
ASTM E438Type I, Class A material classification
Thermal expansion3.3 x 10^-6 K^-1, general glass-family coefficient
Hydrolytic resistanceHigh; lot results are documented through the manufacturer quality process
General chemical durabilityUseful for many laboratory compounds; not unlimited chemical inertness
Glass contact surfaceBorosilicate glass, with amber coloring applied externally
Closure materialsMust be independently checked for the selected GL 25 screw cap and seal
Specific extractables/leachables studyRequest the relevant manufacturer dossier; no universal assay claimed here

Glass compatibility note: Type I classification applies to the glass. It is not a universal chemical-resistance or toxicological certification for a finished bottle with a separately selected plastic closure.

Lot Traceability, Retrace Code, and Certificate of Analysis

DWK provides a lot-specific Certificate of Analysis for DURAN PURE bottles and identifies single-lot delivery and 100% traceability of manufacturing steps as key product-family characteristics.

The Retrace Code supports identification of manufacturing-lot information and retrieval of the associated certificate through DWK's certificate system. This is useful for regulated receiving inspection, supplier qualification, documentation control, and batch-specific investigation.

  1. Receive the case: Confirm article number 818061406 and ten bottles.
  2. Identify the lot: Record the supplied batch or Retrace Code.
  3. Obtain the CoA: Use the included documentation or DWK's certificate lookup.
  4. Verify the document: Match article number, lot identity, and manufacturer information.
  5. Review acceptance data: Check applicable hydrolytic, quality, and inspection results.
  6. Confirm expiry: Match the documented expiration date to the physical lot label.
  7. Retain the record: File it according to the laboratory or manufacturer quality system.

The specific test values, manufacture date, expiry date, and lot number vary by delivered batch. They must not be inferred from a historical certificate for a different lot or from the general product family.

Five-Year Manufacturer Shelf Life: Correct Interpretation

DWK assigns DURAN PURE bottles a five-year manufacturer shelf life, and identifies an expiry date on the bottle's labeling and corresponding CoA. This is a product-quality and inventory-control designation supporting pharmaceutical manufacturing requirements.

The specific remaining shelf life at the time of purchase depends on the manufacturing date of the delivered lot. A newly delivered case is not automatically guaranteed to have five complete years remaining unless the purchasing terms explicitly establish a minimum remaining shelf-life requirement.

Shelf-life question Correct treatment
Manufacturer assigned shelf lifeFive years
Actual expiry dateRead from the delivered lot label and CoA
Remaining shelf life on receiptCalculate from the actual expiry and receipt date
Inventory controlsFollow approved storage and FEFO/lot-control procedures
Expiry of contents placed in bottleSeparate product-specific stability and dating decision
Reprocessing effect on datingRequires quality-system evaluation

Important: The five-year manufacturer shelf life describes DURAN PURE bottle inventory dating. It does not establish a five-year shelf life for an API, compounded preparation, reagent, or other material subsequently stored in the bottle.

Pharmaceutical Regulatory Support: DMFs, Pharmacopoeias, and Change Control

The DURAN PURE range is supported by manufacturer regulatory documentation intended to help pharmaceutical manufacturers qualify the container and reference relevant materials in regulatory processes.

DWK identifies FDA Type III Packaging Material DMF #28042 for DURAN PURE bottles and China CDE/NMPA registration B20220000306. Separate DURAN PURE cap products have their own regulatory references; those should not be confused with the bottle filing.

DWK also identifies the PURE bottle line with international pharmacopoeial requirements and batch testing of hydrolytic resistance according to EP, USP, and JP procedures. Applicable declarations, specifications, and actual lot test results should be obtained from current manufacturer documentation.

Regulatory / quality reference What it means
FDA Type III DMF #28042DWK-filed packaging-material documentation for the PURE bottle range
China CDE/NMPA B20220000306Manufacturer-listed China regulatory registration reference for bottles
USP / EP / JP hydrolytic testingBatch analysis referenced by manufacturer product data
Lot-specific Certificate of AnalysisDocumentation of the relevant manufacturing lot
Change controlManaged manufacturer product/process changes with customer notification
Supplier qualification / validation dossierAdditional documents may be obtained from DWK for applicable requirements
Finished drug-product approvalNot established by the existence of the bottle DMF
Validated container-closure integrityMust be established for the actual bottle, cap, seal, and application

Regulatory distinction: A Type III DMF is a regulatory-support filing, not a standalone FDA approval, a guarantee of compliance for every finished drug product, or permission to use the bottle in all sterile pharmaceutical applications without qualification.

Temporary Dust Cover vs. Functional GL 25 Screw Cap

DURAN PURE bottles are supplied with a temporary protective cover. DWK describes the cover as a contamination-control feature during storage and transportation and explicitly states that a functional screw cap must be purchased separately.

The supplied dust cover is not a tested closure for liquid containment, vapor control, product transport, or long-term pharmaceutical storage. It should not be substituted for a selected and qualified GL 25 cap.

Feature Supplied dust cover Separately selected screw cap
Included with 818061406YesNo
PurposeHelp limit interior contamination during transitClose the bottle for an approved application
GL 25 cap material and sealNot a functional closure specificationMust be selected and verified
Liquid leak containmentNot certifiedDepends on cap, seal, and validated use
Solvent chemical compatibilityNot established for filled storageEvaluate actual cap and seal materials
Autoclave processingDo not assume approvedFollow cap-specific instructions and validated cycle

Procurement control: A laboratory ordering ten 818061406 bottles may need ten separate functional GL 25 caps. Select closure count and compatibility independently rather than treating a case of bottles as ten finished bottle-and-cap assemblies.

Related GL 25 Premium Closure: DURAN PURE 891081306

DWK offers DURAN PURE 891081306, a separately sold GL 25 premium screw cap intended for the DURAN PURE GL 25 bottle system. It has a perfluoroalkoxy (PFA) cap body with a PTFE-coated silicone seal.

DWK lists this cap at five per pack and describes it as autoclavable. Its exact cap specification lists 200°C maximum temperature. This cap-specific rating must not be assigned to the glass bottle or to other closure materials.

  • Accessory SKU: 891081306
  • Product: DURAN PURE GL 25 premium screw cap
  • Thread: GL 25
  • Cap body: PFA
  • Seal: PTFE-coated silicone
  • Color: Transparent
  • Autoclavable: Yes, per cap specification
  • Manufacturer-listed maximum temperature: 200°C
  • Quantity: 5 caps per pack
  • Included with bottle SKU 818061406: No; separately sold

DWK's cap information also lists separate quality, inspection, traceability, and regulatory characteristics. Those cap-specific claims do not automatically apply to any generic GL 25 closure.

Material and process caution: The PFA cap and PTFE-coated silicone liner are not the same material as the temporary dust cover. For filled-product use, qualify the actual screw-cap and seal assembly, including chemical compatibility, cap torque, cleaning, sterilization, and container-closure integrity.

Sterility, Autoclavability, and Ready-to-Use Status

The exact DURAN PURE 818061406 bottle specification states autoclavable: yes. DWK's general PURE guidance discusses steam sterilization for compatible bottle-and-cap configurations. However, the supplied bottle is non-sterile, and an autoclavability designation is not the same as validated sterility upon delivery.

DWK notes that PURE bottles are not additionally washed after manufacture and are not automatically certified particle-free or ready-to-use. The controlled handling and protective cover are precautions, not a replacement for a user-defined cleaning or sterilization procedure.

Question Correct interpretation
Is the glass bottle autoclavable?Yes, exact-SKU manufacturer designation
Is the bottle supplied sterile?No, standard PURE supply is non-sterile
Is the bottle certified particle-free?Not in its standard supplied state
Is the bottle prewashed for direct aseptic filling?No additional washing after manufacturing is stated by DWK
Is the temporary dust cover a sterile barrier?No sterile-barrier certification established
Is any GL 25 cap automatically autoclavable?No; use cap-specific material and process data
Can a sterilization process be validated?Follow applicable DWK guidance and the facility's qualified cycle
Can DWK provide further processed PURE bottles?Custom cleaning, depyrogenation, sterilization, and packaging options may be arranged separately

DWK's PURE guidance discusses typical steam-sterilization practices such as 121°C for 15-20 minutes for appropriate configurations. This should be treated as general manufacturer guidance, not a site-validated cycle for every load, protective cover, selected closure, or filling process.

Processing requirement: Remove or manage the temporary protective cover according to the approved procedure. Confirm that the bottle and separately purchased cap are compatible with the proposed sterilization method and that the process meets the intended cleanliness, bioburden, endotoxin, and sterility requirements.

Controlled Manufacturing and Cleanroom Qualification

DURAN PURE products are intended for quality-controlled pharmaceutical and biotechnology workflows, but not every PURE component is made or delivered under identical cleanroom conditions.

DWK explains that glass bottles are not formed inside a cleanroom. Instead, the PURE manufacturing process incorporates controlled handling after production and immediate application of a protective dust cover. Separately sold PURE caps are manufactured and packaged under their own controlled conditions.

The 818061406 bottle's documentation does not establish a finished product ISO 14644 cleanliness classification, sterile barrier, validated endotoxin limit, or DNase/RNase-free certificate for the standard delivered case.

Cleanroom qualification boundary: 100% visual inspection, traceability, and protective covers do not mean the glass bottles are sterile or suitable for direct aseptic processing without approved preparation and qualification.

Chemical Compatibility and Filled-Product Qualification

For a filled DURAN PURE bottle, the chemical-contact system includes the Type I borosilicate glass and any separately selected GL 25 cap body, liner, seal, or other accessory. Glass compatibility alone is insufficient when a formulation can contact the closure or generate vapors.

Contents or exposure Qualification checkpoint
Light-sensitive APIsConfirm the relevant photostability requirements and container protection
Aqueous formulationsReview pH, ionic strength, extractables, and closure compatibility
Organic solventsCheck borosilicate glass and the actual PFA/PTFE/silicone or alternate closure materials
Acidic formulationsAssess the specific chemical; glass is not universally acid-resistant
Strong alkaline mixturesReview potential borosilicate glass attack and closure interactions
Volatile compoundsValidate the functional screw-cap seal, vapor containment, and storage conditions
Low-extractables requirementsRequest product-specific and formulation-relevant extractables/leachables information
Terminal sterilizationValidate bottle, closure, fill volume, and process as a complete configuration
Transport of filled materialsFollow packaging, leak testing, and relevant dangerous-goods requirements

No universal chemical-resistance certification or finished-product container-closure integrity result is established by the generic PURE bottle specifications. The laboratory should assess the real contents, concentration, exposure duration, storage temperature, and sealing method.

GL 25 Thread and Physical Dimensions

DWK specifies 25 mL capacity, 36 mm diameter, 70 mm height, and GL 25 threaded finish. These characteristics define the basic 818061406 bottle and distinguish it from larger DURAN PURE amber GL 45 models.

Parameter Practical significance
25 mL nominal volumeProduct size; not calibrated volumetric accuracy
36 mm diameterStorage rack and equipment-fit check
70 mm bottle heightManufacturer-listed height; allow added space for functional caps
GL 25 threadRequires appropriate GL 25 functional closure
Amber exteriorLight-protective finish, with documented wavelength-range performance
Temporary dust coverProtective transport covering, not a storage seal
Graduation markingsExact 25 mL marking scale not established in current SKU data

Do not assume the bare bottle's height equals the overall height with a selected pharmaceutical cap. The separate DURAN PURE 891081306 GL 25 premium cap has its own dimensions and packaging specifications.

Related DURAN PURE Bottle and Closure Configurations

DWK offers DURAN PURE bottles in clear and amber glass, using different capacities and neck finishes. The following manufacturer configurations support comparison but are not automatic substitutions.

SKU Product Primary distinction
81806140625 mL amber PURE bottleGL 25, amber, 10/case
81801140125 mL clear PURE bottleGL 25, clear, 10/case
818062402100 mL amber PURE bottleGL 45, larger capacity, 10/case
818063604250 mL amber PURE bottleGL 45, larger capacity, 10/case
891081306DURAN PURE GL 25 premium screw capPFA with PTFE-coated silicone seal, 5/pack

The larger DURAN PURE amber bottles listed here use GL 45 threads. The 25 mL bottle uses GL 25. Each bottle's protective dust cover must not be confused with its separately sold functional cap.

Recommended Receiving and Qualification Checklist
  1. Verify exact product: Confirm DURAN PURE 818061406.
  2. Confirm specifications: 25 mL, amber, GL 25, 36 mm diameter, 70 mm height.
  3. Check the quantity: Confirm ten bottles per manufacturer case.
  4. Inspect packaging: Check for damage, breakage, and missing protective dust covers.
  5. Verify single-lot presentation: Record manufacturer lot information.
  6. Review CoA: Confirm document matches the supplied article and lot.
  7. Check expiration: Review the five-year manufacturer shelf-life dating for the actual lot.
  8. Inspect the amber finish: Look for visible damage that could affect intended protection.
  9. Check the glass and neck: Inspect for chips, cracks, or thread damage.
  10. Specify functional closures: Procure separately qualified GL 25 screw caps as needed.
  11. Review processing: Determine cleaning, particulate, sterilization, and depyrogenation requirements.
  12. Assess application compatibility: Confirm glass, cap, liner, and formulation suitability.
  13. Retain records: Document supplier, lot, quality release, and any approved substitutions.
Cleaning, Handling, Storage, and Reuse Considerations

DWK indicates that DURAN PURE bottles are handled with enhanced precautions after manufacturing, but are not additionally washed for a universal ready-to-use condition. The laboratory must select an appropriate preparation process for the intended manufacturing or analytical application.

  • Inspect bottles and protective covers during receiving.
  • Retain lot identity and manufacturer expiry throughout inventory handling.
  • Use cleaning and rinsing agents compatible with borosilicate glass and the exterior amber finish.
  • Prevent abrasive or mechanical damage to the threaded neck and light-protective exterior.
  • Confirm chemical compatibility for any proposed contents.
  • Select functional GL 25 closures separately and validate sealing performance.
  • Use approved cleaning, sterilization, and depyrogenation procedures when required.
  • Keep light-sensitive compounds under their validated storage and handling conditions.
  • Control reused containers through appropriate cleanliness, carryover, and inspection criteria.
  • Do not assume ordinary GL 25 bottles or protective dust covers are certified hazardous-material transport packages.
Important Limitations and Unsupported Assumptions
  • Not clear glass: The exact 818061406 SKU is amber.
  • Not GL 45: The correct thread finish is GL 25.
  • Not a 100 mL bottle: The exact capacity is 25 mL.
  • Not sold individually as the stated case: Manufacturer quantity is 10 bottles.
  • Not supplied with a functional screw cap: Only a protective dust cover is included.
  • Not supplied sterile: Standard DURAN PURE supply is non-sterile.
  • Not certified ready-to-use: Additional process qualification may be needed.
  • Not certified particle-free: The dust cover and 100% visual inspection do not establish that claim.
  • Autoclavable does not mean sterile: The exact glass bottle is autoclavable but requires a validated process when sterility matters.
  • Not automatically depyrogenated: No standard depyrogenation claim is established.
  • Not universally lightproof: Manufacturer transmission performance applies to a specified wavelength region.
  • No guaranteed product stability: Actual formulation photostability must be assessed.
  • Not a calibrated volumetric device: No exact 25 mL calibration tolerance was established.
  • No verified specific graduation interval: Do not invent scale markings.
  • Not automatically leakproof: A functional closure is separate and requires qualification.
  • No universal solvent compatibility: Review glass and closure components.
  • Not an FDA-approved finished drug package: DMF filing alone does not establish that status.
  • Not automatically approved for all GMP applications: End-user qualification is required.
  • No exact lot results in a general SKU listing: Use the delivered lot CoA.
  • No guaranteed five years remaining on delivery: Verify actual manufacture and expiry dates.
  • No confirmed pressure or vacuum rating: Do not infer special operating capability.
  • No guaranteed dangerous-goods transport approval: Additional packaging qualifications may apply.
Technical FAQs

What is DURAN PURE 818061406?

A 25 mL amber Type I borosilicate glass 3.3 bottle with a GL 25 thread, supplied ten per case with temporary protective covers.

What are the bottle dimensions?

36 mm outside diameter and 70 mm manufacturer-listed height.

What does the GL 25 designation mean?

It identifies the bottle's GL 25 screw-thread finish, which requires an appropriately matched closure.

What type of glass is used?

Type I borosilicate glass 3.3, associated with ISO 3585 and ASTM E438 Type I, Class A.

Is the amber color throughout the glass?

DWK describes an exterior, thermally fixed amber coloring process applied to Type I borosilicate glass.

What light protection does amber DURAN PURE provide?

DWK's brochure states less than 10% light transmission from 290 to 450 nm. The actual formulation must be qualified for light stability.

Does the case include functional screw caps?

No. Standard PURE bottles include temporary dust covers. Functional GL 25 screw caps are sold separately.

Can the protective dust cover seal stored liquids?

It is not specified as a functional or certified leakproof closure and should not replace a qualified screw cap.

Which related DURAN PURE cap should I consider?

DWK 891081306 is a separately sold GL 25 premium PFA screw cap with a PTFE-coated silicone seal, supplied five per pack.

Are DURAN PURE bottles sterile upon receipt?

No. DWK identifies standard PURE bottles as non-sterile.

Can 818061406 be autoclaved?

Yes, the exact glass bottle is listed as autoclavable. Validate the cycle and separately selected closures, and do not assume the supplied dust cover is suitable.

Are the bottles ready for aseptic filling?

Not automatically. The standard bottles are not certified sterile, particle-free, depyrogenated, or ready-to-use without further qualification.

Are these bottles manufactured in a cleanroom?

DWK explains that the glass bottles are not formed in a cleanroom. Controlled handling and immediate protective covering follow manufacture.

What does 100% visual inspection mean?

DWK visually inspects each PURE bottle. This does not establish sterility or a certified particle-free condition.

Does a Certificate of Analysis come with the product?

DURAN PURE is supplied with lot-specific CoA documentation. The exact results and dates depend on the delivered manufacturing lot.

What is a Retrace Code?

A manufacturing reference used to identify and retrieve batch documentation through DWK's certificate system.

What does single-lot delivery mean?

DWK identifies a controlled single-lot presentation to support lot consistency and traceability.

What is the manufacturer shelf life?

Five years, with the actual expiry shown for the supplied manufacturing lot.

Does the five-year dating apply to stored contents?

No. Formulations and other contents require their own established stability, storage, and expiry information.

Does DURAN PURE have an FDA Drug Master File?

DWK identifies Type III Packaging Material DMF #28042 for the bottle range. A filing is not FDA approval of a finished drug product.

What Chinese regulatory reference does DWK list?

China CDE/NMPA registration number B20220000306 for the PURE bottle range.

Is a 25 mL DURAN PURE clear bottle available?

Yes. WHEATON/DURAN PURE 818011401 is the corresponding 25 mL clear GL 25 configuration.

Is the 100 mL amber PURE bottle also GL 25?

No. The related 100 mL amber SKU 818062402 uses GL 45.

How many bottles come in the case?

Ten amber 25 mL bottles, each with its temporary protective cover.

Manufacturer Technical References

All links above are manufacturer technical, educational, or certificate resources. No DWK product-detail, catalog-shopping, or purchasing pages are included. All product purchasing inquiries remain directed to SOSCleanroom.

For quotations, GL 25 closures, or lot documentation, email Sales@SOSsupply.com or call (214) 340-8574. SOSCleanroom can assist with DURAN PURE exact-SKU sourcing, amber and clear bottle comparison, GL 25 closure selection, CoA retrieval, and applicable pharmaceutical quality documentation. Technical insight: DURAN PURE 818061406 combines Type I borosilicate glass, exterior amber light protection, controlled manufacturer traceability, and lot documentation. Safe pharmaceutical use depends on the complete bottle-and-cap configuration, appropriate processing, and application-specific qualification. Last updated: October 28, 2026 © 2026 Specialty Optical Systems, Inc. (dba SOSCleanroom). All rights reserved.