Product Category

GMP Solution

ICH-Q7 GMP Manufactured Product

Water for Injection (WFI),
USP, EP, JP,
GMP Excipient Grade

Sterile Filtered* into Bio-Compatible Sterile Single Use Pkg.

Product Code: WAFI-3150 | Previously: WI3150

Intended For Critical BioPharma Applications


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.

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

pH

5.0 – 7.0

Total Organic Carbon <643> ♦

 

Meets USP/EP Requirements

pH

 

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

pH

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

List of C of As files
WAFI_CoA_WAFI-0124-00000.pdf

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Product-image
formula-image

WAFI-3150

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

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.

Additional Packaging Information

https://www.biospectra.us/technical/packaging