ICH-Q7 GMP Manufactured Product
Water for Injection (WFI)
Sterile Filtered* into Bio-Compatible Sterile Single Use Pkg.
Intended for use as a critical GMP Solution and Excipient for further parenteral manufacturing. *Intended for use in further parenteral manufacturing that requires terminal sterilization. Not intended for use as a sterile product.
CAS #: 7732-18-5
Formula: H2O
pH @ 25°C: 6.0 – 8.0
Melting Point: 0°C
Density: 1.00 g/cm3 @ 3.98°C
Storage Temp: 5°C to 30°C
Boiling Point: 100°C
F.W.: 18.02 g/mol
Product Specifications
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ANALYSIS |
SPECIFICATIONS (USP) |
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|---|---|---|---|
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Less than 0.25 EU/mL |
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Solution Remains Faintly pink |
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Meets USP/EP Requirements |
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pH |
5.0 – 7.0 |
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Meets USP/EP Requirements |
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Meets USP/EP Requirements |
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ANALYSIS |
SPECIFICATIONS (EP) |
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|---|---|---|---|
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Conforms |
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Clear and Colorless Liquid |
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10 ppb max. |
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≤ 0.2 ppm |
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Bacterial Endotoxins |
Less than 0.25 EU/mL |
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Calcium and Magnesium |
A Blue Color is Produced |
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Chlorides |
No Change in Appearance |
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Conductivity ♦ |
Meets the Requirements |
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Microbial Monitoring |
<10 CFU/100mL |
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Nitrates |
0.2 ppm max. |
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Solution Remains Faintly pink |
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Particulate Matter |
Meets USP/EP Requirements |
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pH |
5.0 – 7.0 |
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Residue on Evaporation |
≤ 3.0 mg (0.003%) | ||
| Total Organic Carbon ♦ | 0.5 mg/L max. |
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ANALYSIS |
SPECIFICATIONS (JP) |
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|---|---|---|---|
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Clear, colorless liquid, no odor |
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Less than 0.25 EU/mL |
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Not more than 2.1μS/cm-1 |
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Not more than 0.50mg/L |
MEETS STATED VALUE AT THE TIME OF PACKAGING
General Product Description:
The manufacturing of Bio Excipient Grade GMP WFI, WAFI-3150 is performed at BioSpectra’s Bangor, PA, US FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.
- Molecular Formula: H2O
- Molecular Weight: 18.02 g/mol
- CAS #: 7732-18-5
- GMP WFI is a clear, colorless liquid.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all GMP WFI, WAFI-3150 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- GMP WFI manufactured at BioSpectra and any raw materials used in the manufacture of GMP WFI at BioSpectra are not subject to genetic modification.
GMP Compliance:
Bio Excipient Grade GMP WFI, WAFI-3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of GMP WFI is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for GMP WFI is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and store at 5°C to 30°C
Package Sizes:
Sterile, Single use 1000L totes, 200L drums, 4L and 1L bottles.
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.