Purified Water Specification as per IP/BP/USP : Pharmaceutical Guidelines

Purified Water Specification as per IP/BP/USP

Specification and limit of tests of Purified Water as per USP, EP, BP and IP Pharmacopoeias.

Sr. No.
PARAMETERS
LIMITS
1
Description
Clear, Colourless, odourless and tasteless liquid.
2
pH
Between 5.0 to 7.0
3
Conductivity
Not more than 1µS/Cm
4
Acidity / Alkalinity
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.
5
Ammonium
Test solution should not be coloured in intense with compared to standard solution.
6
Calcium & magnesium
A Pure blue coloured should be produced.
7
Heavy Metals
Not more than 0.1ppm
8
Chloride
The appearance of the solution should not be changed for at least 15 minutes.
9
Nitrate
Not more than 0.2 ppm
10
Sulphate
The appearance of the solution should not be changed for at least 1 hour.
11
Oxidisable substances
The test solution should remain faintly pink.
12
Residue on evaporation
Not more than 0.001%

13
Microbiological limits
Total bacterial Count
Not more than 100 cfu / ml
Total Fungal count
Not more than 10 cfu / ml
Escherichia Coli
To be absent
Salmonella 
To be absent
Pseudomonas aurogenosa
To be absent
Staphylococcus aureus
To be absent






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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21 comments: Post Yours! Read Comment Policy ▼

  1. Dear Sir,
    please 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?

    ReplyDelete
  2. 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.

    ReplyDelete
  3. May i know purified water specification as per IP 2014

    ReplyDelete
  4. Dear Sir,

    Is it necessary to do Bacterial Endotoxin Test for PW which is not in direct contact with product and not used for preparation of dialysis solution.

    It is only used for claening & washing purpose and final wash is of WFI

    ReplyDelete
  5. Dear Sir,

    We have qualified PW system intially.
    After that one point is added in its loop system for futher storage of water in other location. So what should be the qualification approach for this point.

    And the further storage can be claimed as DM water as it is not in direct contact with product?

    ReplyDelete
  6. Dear Nikunj,
    Washing and all othe work should be done in WFI only for the preparation of dialysis solution preparation.

    ReplyDelete
  7. If new point is added in circulation loop then you should qualify the WFI system again.

    ReplyDelete
  8. Dear sir
    Is purified water is distilled water????

    ReplyDelete
  9. Both are different, please consult USP.

    ReplyDelete
  10. We 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
    for 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

    ReplyDelete
  11. dear sir,
    what is the reason behind failure of pw water in toc and microbial test

    ReplyDelete
  12. Purified water and single reverse osmosis water is same or different?

    ReplyDelete
  13. Dear Sir,
    Our 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'?

    ReplyDelete
  14. Is it necessary to calculate the contact time of UV and water for bioload?

    ReplyDelete
  15. Hi,
    Our 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..

    ReplyDelete
  16. Dear sir
    Is it necessary for made changes in Water alert and action limit .which guidelines i have to refer..?

    ReplyDelete
  17. Sir what are microbial limits for water in non sterile prepration in pharmaceuticals

    ReplyDelete
    Replies
    1. Purified water is used in preparation of non sterile formulation.

      Delete
  18. our company is manufacturing effervescent tablets, what are the limits in this preparation.

    ReplyDelete
  19. Why the final limit of Purified water is 100 CFU/ml.

    ReplyDelete
  20. Sir,
    we have reverse osmosis plant ,kindly tell us the cfu/ml limits of bacteria and fungi of RO2 Water.

    ReplyDelete

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