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.
Dr. Ankur Choudhary is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question
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You can ask questions related to this post here.
for 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