Specifications For Water For Injection (WFI) as per USP

 

Sr.No.	Test	Acceptance criteria
1	Description	Clear, colorless and odorless liquid.
2	Total Organic carbon	Not more than 500 ppb
3	Conductivity (at 25°C)	Less than 1.3 µS/cm
4	Bacterial Endotoxins	Less than 0.25 EU/ml.
5	Microbial limit test
a.	Total aerobic microbial count	Less than 10 cfu / 100ml.
b.	Pathogens
i.	Escherichia coli	Should be absent
ii.	Salmonella sp.	Should be absent
iii.	Pseudomonas aeruginosa	Should be absent
iv.	Staphylococcus aureus	Should be absent
6	Acidity or alkalinity	No red or blue color produced.
7	pH	Between 5.0 and 7.0
8	Ammonium	Less than 0.2 ppm
9	Calcium and magnesium	A pure blue colour is produced
10	Heavy metals	Less than 0.1 ppm.
11	Chlorides	The solution shows no change in appearance.
12	Nitrates	Less than 0.2 ppm
13	Sulphates	The solution shows no change in appearance.
14	Oxidisable substances	The solution remains faintly pink
15	Residue on evaporation	Less than 0.001 %