Sterile Water

Sterile-water laboratory ancillary · preservative, compendial and container status must be confirmed by lot

Multi-attribute · Batch COACAS 7732-18-5RUO
Batch COA
MOQ1 kit (10 vials) per SKU
Supplied formAqueous laboratory ancillary (H₂O; non-peptide); sterile status requires released-lot evidence
Lead time7–14 days
Sterile Water — Clear, colourless liquid; appearance alone does not establish sterility, endotoxin status, compendial grade or container integrity
Sterile Water — Clear, colourless liquid; appearance alone does not establish sterility, endotoxin status, compendial grade or container integrity · Representative packaging image · verify the ordered lot
Representative packaging image · verify the ordered lot

Decision summary

Key benefits

  • Defensible laboratory value is a low-complexity aqueous solvent for validated reconstitution, dilution, blanks, recovery studies and method controls
  • Suitability is not universal: even water can drive hydrolysis, oxidation, adsorption, aggregation, pH shift or microbial contamination after opening
  • No injectable, clinical or “pyrogen-free” claim follows from clarity or the word sterile alone.
Published research context is presented for literature orientation only. It is not a dosing, treatment or human-use instruction.

Qualification data

Specifications to confirm against the released lot

CAS
7732-18-5
Formula
Not applicable to the supplied material
Molecular weight
18.02 g/mol
Appearance
Clear, colourless liquid; appearance alone does not establish sterility, endotoxin status, compendial grade or container integrity
Purity
Not expressed as an HPLC area-purity percentage; qualify chemical water attributes, sterility, endotoxin and container closure separately · target, verify batch COA
Storage
Follow the released-lot label, container specification and stability data. Do not infer controlled-room-temperature ranges, freezing restrictions, immediate-use rules or four-hour pharmacy-bulk-package limits unless the supplied lot is the exact labelled presentation to which those instructions apply. Quarantine damaged containers and temperature excursions.
MOQ
1 kit (10 vials) per SKU
Lead time
7–14 days

Qualification matrix

Identity, purity and content are separate release questions.

Identity

Confirm the stated molecule and supplied form. Start with the matching batch COA; request sequence-level evidence only when the buyer's written procedure requires it and availability or a separate scope has been agreed.

Purity

Review RP-HPLC method conditions, wavelength, integration and related-peak handling. A percentage without the method is not enough.

Stability

Follow the storage condition stated on the batch COA or label from receipt onward.

Research context

What researchers study about Sterile Water

Water has formula H₂O, but the words “sterile water” do not establish a pharmacopeial grade or finished-drug status. WFI refers to water meeting an applicable monograph; Sterile Water for Injection is a packaged sterile finished presentation; bacteriostatic water contains preservative; saline contains solute; and laboratory sterile water may be supplied only for research. Chemical water quality, sterility, bacterial endotoxin, particulate control, fill volume, container closure and shelf life are separate qualification dimensions.

  • Appropriate laboratory contexts include validated reconstitution and dilution, analytical blanks, recovery and adsorption studies, container-compatibility work and method controls
  • Suitability must be established for the exact analyte, method, water grade and released lot.

Mechanism context

The question the literature is testing

Water acts as a solvent through hydration and hydrogen-bonding interactions; it has no product-specific pharmacological mechanism. Dissolution and recovery depend on analyte chemistry, pH, ionic strength, concentration, vessel surface and time. A clear solution does not prove complete recovery, stability or absence of subvisible particles.

Evidence map

Research routes and exposure context

Evidence tierAnalytical / laboratory context
Routes reported in sources
No administration route applies
Dose / exposure contextProtocol-specific; verify the cited primary source
Routes and exposure contexts summarize cited studies or approved finished-product labels. They are not instructions for administering this RUO material; no customer dose is provided.

Evidence boundaries

Compatibility, limitations and decision context

  • Not for human or veterinary administration
  • FDA labels for specified Sterile Water for Injection finished products warn that undiluted intravenous administration of solute-free hypotonic water can cause haemolysis, but those clinical labels do not qualify this RUO item as an injectable product
  • Container compromise, microbial contamination, endotoxin, particulates and incorrect grade assignment are material laboratory risks.

Interactions reported in the literature

  • No blanket compatibility statement applies
  • Water-soluble does not mean stable, quantitatively recovered or assay-compatible
  • Compare required pH, ionic strength, tonicity, preservative tolerance, adsorption and oxidation risk
  • Bacteriostatic water and saline are different materials and must not be substituted without method validation.
Literature context is not a supplier release result or human-use instruction. Follow your institution's approved laboratory risk assessment.

Batch documentation

Sterile Water batch COAs

Laboratory: Manufacturer's QC laboratory

  • Blurred preview of a Sterile Water 3 mL batch COA3 mL
  • Blurred preview of a Sterile Water 10 mL batch COA10 mL

Previews are blurred on purpose so the documents cannot be reused; third-party reports show their first page only. Sales sends the clear full version for the product and strength you ask about.

Independent test fails? Full refund.

Representative records, refreshed periodically

Published COAs show recent representative batches and may not be the newest. For a quote or shipment, sales confirms the lot and sends its COA.

Third-party reports, added progressively

Previews of the first page of third-party reports are on our Quality page and on the matching product pages; sales sends the full report on request. You can also send any vial from your order to an independent laboratory of your choice. Unless agreed otherwise in writing, the buyer pays for optional testing.

Help reviewing your COA

Need help reading a batch COA or third-party report? Sales can explain the test items, specifications and how the results relate to the lot under discussion.

On every batch COA: Batch COA · Verify LyoPep

Ask for the current packet, not a generic certificate

  • Require exact grade and monograph claim, lot and manufacturer traceability, chemical attributes such as conductivity and total organic carbon where applicable, bacterial-endotoxin method and result, sterility method and result, appearance and particulates, fill volume, container-closure integrity or validation, sterilization information and shelf-life data
  • Reject “≥99% purity,” generic injectable-grade language or “pyrogen-free” without the corresponding specification and released-lot evidence.
Batch COA for the released lotHPLC purity with method contextMS identity resultEndotoxin resultFill amount (measured content per vial)SDS and handling statement

Available fills

Quote the fill and pack configuration you need

Reference SKUFillBase pack
STER33 mL10 vials
STER1010 mL10 vials

Handling

Plan storage before the parcel arrives

Follow the released-lot label, container specification and stability data. Do not infer controlled-room-temperature ranges, freezing restrictions, immediate-use rules or four-hour pharmacy-bulk-package limits unless the supplied lot is the exact labelled presentation to which those instructions apply. Quarantine damaged containers and temperature excursions.

State the destination and timing so receipt can be planned, then move the material into its stated storage condition on arrival.

Buyer FAQ

Terms to settle before the purchase order

Can a buyer arrange third-party testing?+

Yes. You can send any vial from your order to an independent laboratory of your choice. If you want the laboratory, specification, sampling, method and acceptance rule agreed with us before testing, sales confirms them in writing. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

What if my own lab test shows the product is out of specification?+

Send any vial from your order to an independent laboratory of your choice. If the report shows the product does not meet the specification on its COA — purity below the stated minimum, or an identity that does not match — share the report with our sales team and we refund that product in full.

Does HPLC purity prove peptide content?+

No. Chromatographic purity describes the relative peak profile under a stated method. Identity, water, counter-ion, residual solvents and assay/content may require separate methods.

How should material be stored after delivery?+

Move it into the storage condition stated on the batch COA or label as soon as it arrives, and record the package condition on receipt.

How are payment terms handled?+

Available methods and milestones depend on order value, destination and project type. The pro forma invoice should state currency, bank details, fees, payment milestones and the release condition.

Why must the testing laboratory understand peptide chemistry?+

Free-base and salt forms, hydrophilic and hydrophobic sequences, aggregation and adsorption can change sample preparation and method suitability. Use a laboratory experienced with the molecule class.

These are buyer-qualification references, not claims that this RUO material is regulated, certified or released under those frameworks. Applicability depends on the buyer's workflow and jurisdiction.

Selected sources

Literature behind the research context

  • Primary references include the USP Water for Injection monograph, USP General Chapter 〈643〉 Total Organic Carbon, FDA DailyMed labelling for a specified Sterile Water for Injection finished presentation, and NIH PubChem CID 962 for molecular identity. Label-specific storage, entry and discard instructions are examples for those named presentations only and are not automatically attributes of this RUO catalogue lot.
  1. 01

    Hemolysis and renal failure associated with use of sterile water for injection to dilute 25% human albumin solution

    American Journal of Health-System Pharmacy · 1998 · peer-reviewed case series / letter

    Open source
  2. 02

    Hemolysis Associated with 25% Human Albumin Diluted with Sterile Water -- United States, 1994-1998

    Morbidity and Mortality Weekly Report (MMWR) · 1999 · regulatory/public-health surveillance report

    Open source
  3. 03

    Iatrogenic Water Intoxication After Intravenous Infusion of Sterile Water: A Rare and Preventable Case

    Cureus · 2025 · peer-reviewed case report

    Open source
  4. 04

    Water for Injection

    USP-NF (United States Pharmacopeia-National Formulary) · 2018 · official compendial monograph

    Open source
  5. 05

    Sterile Water for Injection, USP -- Official Prescribing Information / Package Insert

    Pfizer Official Labeling (labeling.pfizer.com) · 2024 · regulatory document / manufacturer official labeling

    Open source
  6. 06

    Sterile Water for Injection, USP -- FDA Drug Label

    DailyMed (U.S. National Library of Medicine) · 2023 · regulatory document / manufacturer official labeling (DailyMed repository)

    Open source
  7. 07

    ISMP List of High-Alert Medications in Acute Care Settings

    Institute for Safe Medication Practices (ISMP) · 2024 · industry patient-safety organization guidance document

    Open source
  8. 08

    Sterile Water Should Not Be Given "Freely"

    Pennsylvania Patient Safety Advisory · 2008 · state regulatory patient-safety advisory

    Open source

Product FAQ

Questions buyers ask about Sterile Water

Which evidence is needed to support a sterile-water claim?+

Request the claimed monograph and edition, manufacturing-water basis, chemical tests such as conductivity and total organic carbon where applicable, bacterial endotoxin with method and limit, sterility with method and result, appearance and particulates, fill volume, container-closure integrity or validation, sterilization information, lot traceability and shelf-life data. Sterility and endotoxin are different tests, and “pyrogen-free” should not be inferred from an LAL result alone.

Evidence before order

Buyer intelligence