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 %
|
Specification for Water for Injection (WFI) as per USP
Know the specification of Water for Injection (WFI) as per United States Pharmacopoeia.
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Please change conductivity limit NMT 1.3 micro simons/cm (1.3μS/cm). Because 1.3 mS/cm means milli simons/cm.
ReplyDeletefor the heavy metals parameter which is <0.1ppm, is it the total of all heavy metals or individual ions like Mg+, Fe+?
ReplyDeleteAll heavy metals including pb and cd etc.
Deletewhy NIirates is less then 0.2ppm ?
ReplyDeleteWhy conductivity important in wfi water
ReplyDelete