Water For injection (WFI) Specification

S.No	Test	Acceptance criteria
1	pH	Between 5.0 to 7.0
2	Description	Clear, Colorless and odorless liquid
3	Total Organic Compound (TOC)	Not more than 500 ppb
5	Total Free Chlorine (TFC)	Not more than 5 ppm
6	Total Suspended Solids (TSS)	Not more than 500 ppm
7	Total Hardness	Not more than 500 ppm
8	Total Dissolved Solids (TDS)	Less than 0.1 ppm
9	Conductivity (at 250C)	Less than 1.3 µS/ cm.
10	Acidity or Alkalinity	No red or blue colour prouced.
11	Ammonium	Less than 0.2 ppm
12	Calcium and Magnesium	A pure blue color is produced.
13	Heavy metals	Less than 0.1 ppm
14	Chlorides	The soloution shows no change in appearance.
15	Nitrates	Less than 0.2 ppm
16	Sulphates	The soloution shows no change in appearance.
17	Oxidasable substances	The Solution remains faintly pink.
18	Residue on evaparation	Less than 0.001 %
19	Bacterial Endotoxins	Less than 0.25 EU/mL
20	Microbial Limit Test
	Total Areobic Microbial Count	Less than 10 cfu/100mL
21	Specified Microorganisms
	Escherichia coli	Should be absent
	Salmonella Spp	Should be absent
	Psedomonas aeruginosa	Should be absent
	Staphylococcus aureus	Should be absent