Sterile Water

• 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.

CAS

7732-18-5

Formula

Not applicable to the supplied material

Molecular weight

18.015 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

On request

Lead time

7–14 days

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.

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.

• 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.

Sterile Water3 mL · WHJLP-STER3-260527-D

Sterile Water10 mL · WHJLP-STER10-260527-D

Representative records, refreshed periodically

Published COAs show representative factory batches and may not be the latest available. For a current quote or shipment, our sales team can confirm the applicable lot and provide its COA.

Independent testing, arranged on request

Third-party reports are not routinely published. If independent verification is required, we can agree the laboratory, method, acceptance criteria and remedy before testing. If the agreed specification is not met, an appropriate resolution—including a refund where applicable—can be discussed under the agreed terms. Unless otherwise agreed in writing, the buyer pays the cost of this optional testing.

Help reviewing your COA

Need help reading a factory COA or third-party report? Our sales team can clarify test items, specifications and how the results relate to the lot under discussion.

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.

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 destination, season, acceptable transit exposure and whether your protocol requires insulated or cold-chain service. Additional temperature-control cost is quoted explicitly.

• 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