Specification for Water for Injection (WFI) as per USP : Pharmaceutical Guidelines

Specification for Water for Injection (WFI) as per USP

Know the specification of Water for Injection (WFI) as per United States Pharmacopoeia.
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 mS/cm
4
Bacterial Endotoxins
Less than 0.25EU/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 %





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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1 comment: Post Yours! Read Comment Policy ▼

  1. Please change conductivity limit NMT 1.3 micro simons/cm (1.3μS/cm). Because 1.3 mS/cm means milli simons/cm.

    ReplyDelete

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