Water for Injections Ph.Eur. 10 ml Ampoules

Water for Injections Ph.Eur. is a sterile, pharmaceutical-grade water supplied in hermetically sealed glass ampoules for use as a solvent in the preparation, dilution, and reconstitution of medications for parenteral administration. This pyrogen-free, sterile solution meets the stringent quality standards of the European Pharmacopoeia and is free from antimicrobial agents, making it suitable for various medical applications requiring high-purity water.

Key Features:

• Sterile, pharmaceutical-grade water meeting European Pharmacopoeia (Ph.Eur.) standards
• Clear, colorless, odorless, and particle-free solution
• Non-pyrogenic formulation for safe parenteral use
• Free from antimicrobial agents and preservatives
• Hypotonic solution requiring adjustment to isotonicity before administration
• Hermetically sealed Type I glass ampoules ensuring sterility and integrity
• Single-use ampoules minimize contamination risk
• 10 ml volume suitable for precise dilution and reconstitution
• pH range: 5.0-7.0
• Meets conductivity and purity specifications for Water for Injections

Technical Specifications:

• Volume: 10 ml per ampoule
• Container type: Type I clear glass ampoules, hermetically sealed
• Sterility: Sterile, pyrogen-free
• pH: 5.0-7.0
• Composition: 100% Water for Injections Ph.Eur.
• Osmolarity: Hypotonic (requires adjustment for parenteral use)
• Antimicrobial agents: None
• Preservatives: None
• Packaging: Individual ampoules, typically packaged in cartons of 10 or 20 ampoules
• Product code: PL: 45980/0001, PA 1122/1/1
• Storage: Store below 25°C, protect from light
• Shelf life: As indicated on packaging

Applications:

• Dilution and reconstitution of lyophilized (freeze-dried) medications for parenteral administration
• Preparation of injectable solutions requiring sterile diluent
• Vehicle for medications administered via intravenous, intramuscular, or subcutaneous routes
• Irrigation of small wounds and surgical sites
• Dilution of concentrated injectable medications to appropriate concentrations
• Preparation of solutions for infusion therapy
• Cleaning and irrigation of catheters and medical devices
• Minor surgical procedures requiring sterile irrigation
• Laboratory preparation of sterile solutions for medical testing
• Pharmaceutical compounding requiring pharmaceutical-grade water

Usage Instructions:

• Inspect ampoule for cracks, damage, or particulate matter before use
• Use only if solution is clear and ampoule is intact
• Break ampoule at the score line using proper technique
• Use aseptic technique throughout preparation
• Withdraw required volume using sterile syringe and needle
• Add appropriate medication or solute as directed
• Make solution isotonic before parenteral administration if required
• Use immediately after opening ampoule
• Discard any unused portion - do not save for later use
• Follow specific reconstitution instructions for medication being prepared
• Do not use for multiple patients or multiple uses

Safety Information:

• For single use only - discard unused portion immediately after opening
• Do not administer Water for Injections alone intravenously as it may cause hemolysis (red blood cell destruction)
• Must be made isotonic before parenteral administration to prevent hemolysis
• Do not use if ampoule is cracked, damaged, or solution appears cloudy
• Do not use if solution contains visible particles
• Use strict aseptic technique during preparation to maintain sterility
• Check compatibility of medications before mixing with Water for Injections
• Follow medication-specific reconstitution guidelines
• Contraindications depend on the medication being diluted or reconstituted
• Store below 25°C in original packaging, protected from light
• Keep out of reach of children
• Healthcare professional use only
• Dispose of ampoules and unused solutions according to local regulations

Manufacturer: As indicated on packaging (Product License PL: 45980/0001) Regulatory Compliance: Complies with European Pharmacopoeia (Ph.Eur.) monograph for Water for Injections