ANALYSIS |
SPECIFICATIONS (USP) |
||
---|---|---|---|
|
Less than 0.25 EU/mL |
||
|
Solution Remains Faintly pink |
||
|
Meets USP/EP Requirements |
||
pH |
5.0 – 7.0 |
||
|
Meets USP/EP Requirements |
||
|
Meets USP/EP Requirements |
ANALYSIS |
SPECIFICATIONS (EP) |
||
---|---|---|---|
|
Conforms |
||
|
Clear and Colorless Liquid |
||
|
10 ppb max. |
||
|
≤ 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. |
||
|
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) |
||
---|---|---|---|
|
Clear, colorless liquid, no odor |
||
|
Less than 0.25 EU/mL |
||
|
Not more than 2.1μS/cm-1 |
||
|
Not more than 0.50mg/L |
MEETS STATED VALUE AT THE TIME OF PACKAGING
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.
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.
The recommended retest period for GMP WFI is two years from the date of manufacture.
Ship and store at 5°C to 30°C
Sterile, Single use 1000L totes, 200L drums, 4L and 1L bottles.
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.