Water for Injection (WFI) USP EP JP Excipient GMP

Product Specifications

ANALYSIS

SPECIFICATIONS (USP)

Bacterial Endotoxins Test USP <85>

Less than 0.25 EU/mL

Oxidizable Substances

Solution Remains Faintly pink

Particulate Matter

Meets USP/EP Requirements

5.0 – 7.0

Total Organic Carbon <643> ♦

Meets USP/EP Requirements

ANALYSIS

SPECIFICATIONS (EP)

Acidity-Alkalinity

Conforms

Appearance

Clear and Colorless Liquid

Aluminum

10 ppb max.

Ammonium

≤ 0.2 ppm

Bacterial Endotoxins

Less than 0.25 EU/mL

Calcium and Magnesium

A Blue Color is Produced

Chlorides

No Change in Appearance

Conductivity ♦

Meets the Requirements

Microbial Monitoring

<10 CFU/100mL

Nitrates

0.2 ppm max.

Oxidizable Substances

Solution Remains Faintly pink

Particulate Matter

Meets USP/EP Requirements

5.0 – 7.0

Residue on Evaporation

≤ 3.0 mg (0.003%)

Total Organic Carbon ♦

0.5 mg/L max.

ANALYSIS

SPECIFICATIONS (JP)

Description

Clear, colorless liquid, no odor

Bacterial Endotoxins <4.01>

Less than 0.25 EU/mL

Conductivity <2.51> ♦

Not more than 2.1μS/cm^-1

Total Organic Carbon <2.59> ♦

Not more than 0.50mg/L

MEETS STATED VALUE AT THE TIME OF PACKAGING

Printable Version

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.