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  1. Guideline on the quality of water for pharmaceutical use. Table of contents. Executive summary .....................................................................................3. Introduction (background)......................................................................3.

  2. Thermogravimetric moisture analysis defines moisture as the loss of mass observed when the sample is heated and is based, in theory, on the vaporization of water during the drying process; this measurement does not distinguish weight loss of water from

  3. try tests that were previously used to test for water purity. Three stages of conductivity testi. g are described in USP <645>, each more involved than the last. If the requirements o. Stage 1 are met, the water meets the requirements of the test. It is only necessary.

  4. Chemical tests for water. The presence of water is commonly tested for using anhydrous cobalt (II) chloride or anhydrous copper (II) sulfate. Cobalt (II) chloride. Anhydrous cobalt (II) chloride, CoCl 2, is blue. Hydrated cobalt (II) chloride, CoCl 2 •6H 2 O is pink. So, anhydrous cobalt (II) chloride can be used to test for water.

  5. The water quality required depends on the dosage form being manufactured and can be taken from the EMEA "Note for guidance on quality of water for pharmaceutical use". Purified Water is gen-erally used for solid dosage forms (e. g. tablets, capsules) and semi-solid medicinal products (oint-ments).

  6. WATER ANALYSIS 2016 3 I Test Methods for Drinking Water 1. Aerobic Microbial count/Standard plate count 2. Detection of E.coli and Coliform 3. Detection of Coliform (Alternative Method) 4. Detection of Enterococci(Faecal Streptococci) 5. Detection of Salmonella 6. Detection of Shigella sp. 7. Detection of Pseudomonas aeruginosa 8. Detection of ...

  7. This guideline replaces the Note for guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01 EMEA/CVMP/115/01) and CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use (EMEA/CPMP/BWP/1571/02 Rev.1).

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