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 %
|
Mar 23, 2011
Specification for Water for Injection (WFI) as per USP
Know the specification of Water for Injection (WFI) as per United States Pharmacopoeia.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamE Need Help: Ask Question|Follow on Whatsapp
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