Purified water is used in many pharmaceutical products as an ingreadient as well as it is used for washing of manufacturing equipment. Therefore, it has great importance. Purified water specification is given in Indian Pharmacopeia, British Pharmacopeia and United States Pharmacopeia. Purified water used in pharmaceutical manufaturing should pass this specification.
Also see: Purified Water System Validation
Sr. No.
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PARAMETERS
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LIMITS
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1
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Description
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Clear, Colourless, odourless and tasteless liquid.
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2
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pH
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Between 5.0 to 7.0
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3
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Conductivity
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Not more than 1µS/Cm
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4
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Acidity / Alkalinity
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On addition of Methyl red solution the resulting solution should be not red.
On addition of Bromo thymol blue solution the resulting solution should be not blue.
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5
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Ammonium
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Test solution should not be coloured in intense with compared to standard solution.
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6
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Calcium & magnesium
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A Pure blue coloured should be produced.
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7
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Heavy Metals
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Not more than 0.1ppm
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8
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Chloride
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The appearance of the solution should not be changed for at least 15 minutes.
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9
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Nitrate
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Not more than 0.2 ppm
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10
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The appearance of the solution should not be changed for at least 1 hour.
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11
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Oxidisable substances
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The test solution should remain faintly pink.
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12
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Residue on evaporation
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Not more than 0.001%
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13
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Microbiological limits
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Total bacterial Count
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Not more than 100 cfu / ml
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Total Fungal count
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Not more than 10 cfu / ml
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Escherichia Coli
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To be absent
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Salmonella
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To be absent
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Pseudomonas aurogenosa
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To be absent
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Staphylococcus aureus
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To be absent
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Dear Sir,
ReplyDeleteplease tell me what is off line conductivity at 25 deg C as per USP, What is the meaning of ambient temperature, In purified water system loop maintain what temperature?
As per USP purified conductivity at 25 deg. C should be 1.3 µS/cm. Ambient temperature means room temperature. In purified water system loop, temperature is maintained above 60 deg. C.
ReplyDeleteDear Nikunj,
ReplyDeleteWashing and all othe work should be done in WFI only for the preparation of dialysis solution preparation.
If new point is added in circulation loop then you should qualify the WFI system again.
ReplyDeleteDear sir
ReplyDeleteIs purified water is distilled water????
Both are different, please consult USP.
ReplyDeleteWe have water validation chemical report for up-to phase -II and ROE results also came less than of 0.001% for all the sample location, Is that possible to remove the ROE analysis for the PUW
ReplyDeletefor the justification to show the in-organic analysis like calcium,sulphate, nitrate, heavy metals results in specification limits. Is it correct way or ?? kindly post your comment
Dear sir
ReplyDeleteIs it necessary for made changes in Water alert and action limit .which guidelines i have to refer..?
Sir what are microbial limits for water in non sterile prepration in pharmaceuticals
ReplyDeletePurified water is used in preparation of non sterile formulation.
DeleteSir,
ReplyDeletewe have reverse osmosis plant ,kindly tell us the cfu/ml limits of bacteria and fungi of RO2 Water.
In which pharmacopeia are mentioned that water analysis done on SCDA and SDA?
ReplyDeleteSir we know that purified water pH is between 5 to 7, that means it's a acidic nature, my question is why we tasting acidity or alkanity test of purified water, what's our motive?
ReplyDelete