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.
ReplyDeleteMay i know purified water specification as per IP 2014
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,
ReplyDeletewhat is the reason behind failure of pw water in toc and microbial test
Purified water and single reverse osmosis water is same or different?
ReplyDeleteDear Sir,
ReplyDeleteOur company is manufacturing API/NCE material used for pre-clinical up to clinical phase II under CGMP. May i know if the purified water should meet the USP/EP specification? We have established a process purified water (charcoal treatment, softening, UV sanitization and 0.2um filtration) while the water quality is better than drinking water but not good enough to fulfill USP/EP water specification (only conductivity higher than the criteria (2~3uS/cm), others are all within spec. including Total vial count and endotoxin). Is there any problem if we defined the water as 'purified water'?
Is it necessary to calculate the contact time of UV and water for bioload?
ReplyDeleteHi,
ReplyDeleteOur company is pending to qualification new purified water system for QC Lab usage. As such, I enquire what are the test required for qualification in order to comply with all USP/EP/JP/Ch.P and IP.
I am asking this because it seems Ch.P did not specify the qualification needs for lab usage, and the PW specification mentioned in Ch.P actually states approx. 10 tests, which includes nitrite, nitrate, ammonia etc...
Please advice..
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.
Deleteour company is manufacturing effervescent tablets, what are the limits in this preparation.
ReplyDeleteWhy the final limit of Purified water is 100 CFU/ml.
ReplyDeleteSir,
ReplyDeletewe have reverse osmosis plant ,kindly tell us the cfu/ml limits of bacteria and fungi of RO2 Water.
Dear Valor
Deletethe limits is the same of purified water
In which pharmacopeia are mentioned that water analysis done on SCDA and SDA?
ReplyDelete