Water for Injection USP EP JP Excipient GMP

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GMP Solution

ICH Q7 GMP Manufactured Product

Water for Injection (WFI)

Meets USP/EP/JPC, GMP, Excipient
Product Code: WAFI-3150

Sterile Filtered into Bio-Compatible Sterile Single Use Pkg.

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Product Code: WAFI-3150

Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Water for Injection, commonly referred to as WFI, is ultrapure water meeting compendial requirements, used as a solvent in critical pharmaceutical applications. It is commonly used as a cleaning agent for anything that comes into contact with the drug or for making high purity solutions. It can also be used in the manufacture of final drug products, where sterilization takes place later in production process. BioSpectra uses WFI inhouse to manufacture high purity buffer solutions. BioSpectra Water for Injection should not be confused with Sterile Water for Injection, used to dissolve or dilute a drug substance (API), to be immediately administered via injection or infusion. Rather, BioSpectra WFI can only be used in parenteral drug manufacturing that requires further terminal sterilization and is itself not to be considered a sterile product.

CAS #: 7732-18-5
Formula: H₂O
F.W.: 18.02 g/mol

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance

Clear, Colorless Liquid, No Odor

Aluminum (EP)

< = 10 ppb

Ammonium (EP)

< = 0.2 ppm

Endotoxin (USP/EP/JPC)

< 0.25 EU/mL

Calcium and Magnesium (EP)

Passes Test

Chloride (EP)

Passes Test

Conductivity (USP/EP/JPC)

Meets the Requirements

Microbial Monitoring

< 10 CFU/100 mL

Nitrates (EP)

< = 0.2 ppm

Oxidizable Substances (USP/EP)

Passes Test

Particulate Matter (USP/EP)

Meets the Requirements

Residue on Evaporation (EP)

< = 3mg (0.003%)

Total Organic Carbon (USP/EP/JPC)

< = 500 ppb

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Key Product Features:

The manufacturing of Water for Injection is performed at BioSpectra's Bangor, PA facility.
Appears as a clear, colorless liquid with no odor
Manufactured in accordance with ICH Q7
Manufactured in a hormone free and animal free environment
Contains no known major food allergens (as defined by FDA and WHO)
The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
Is not subject to genetic modification
Synonyms: AQUA; Water, Distilled, Conductivity or of Similar Purity

Storage & Shipping:

Refer to SDS

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Package Sizes:

200L, 1,000L, 10L, 4x4L, 6x1L

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.