Purified water very useful and largely in the pharmaceutical Aid (solvent) production pharma industrial as preparation of tablet capsule liquid Ointment and parental preparation Purified water also to be use for all test and Assay and volumetric solution. According to drug Act is produced by distillation deionization or reverse Osmosis processes also may be called Demineralised water (Deionised water) purified water must be meet requirements for following parameter chemical and Microbiological limits

Sr. No. Parameters Limits
1. Description Clear, colourless and odourless liquid.
2. pH 5.0to 7.0
3. Conductivity Not more than 1.3 µs.cmˉ1
4. Acidity or Alkalinity To 10ml freshly boiled & cooled sample, add 0.05ml methyl red solution, the resulting solution should not be red.

To 10ml freshly boiled & cooled sample, add 0.1ml bromothymole blue solution, the resulting solution should not be blue.

5. Aluminium Not more than 10 ppb
6. Ammonium To 20 ml sample, add 1ml alkaline Potassium mercury-iodide solution. Test solution should be less intensely coloured than the reference solution.
6. Calcium & Magnesium Full blue colour should be produced.
7. Chloride Solution should be clear for atleast 15 minutes.
8. Heavy Metals Not more than  0.1 ppm
9. Nitrate Not more than 0.2 ppm
10. Sulphate The appearance of the solution should not be changed for atleast 60 minutes.
11. Oxidisable Substances The test solution should remain faintly pink.
12. Residue on evaporation Not more than  0.001%
13. TOC (Total organic carbon) 500 ppb
14. Microbiological limits
Total bacterial Count Not more than 100 cfu/ml
Escherichia Coli Should be Absent
Salmonella Should be Absent
Pseudomonas aeruginosa Should be Absent


Staphylococcus aureus Should be Absent

Leave a Comment

error: Content is protected !!