Di water

TEMPLATES & PRESENTATIONS
1

Like to read more about DI water for API use as per regulatory guidelines.?
help me in this matter.
SVR

2

Dear Mr. Satya…
Use of deionized water in manufacturign of API shall depend upon the APIs quality requirements and its subsequent formulation.

  1. If your API is non-sterile and intended to use in non-sterile formulation, you can use at least potable water.
  2. If your API is non-sterile and intended to use in non-parenteral sterile formulation, purified water should be used
  3. If your API is sterile and intended to use in non-parenteral formulation, purified water should be used

For more information on same subject, pls have a look at “EMEA/CVMP/115/01”

3

Very correctly put. The above comment says it all.

4

Another question on water quality if you could help. In the purified water delivery syste, we have two online testers for conductivity and TOC. We also have many use points. Sytem is succesfully validated. Do we have to do regular conductivity/TOC testing at use points? If so, how often? If not, based on what guideline (for USA)? Thanks.