美国药典27版纯化水标准

美国药典27版纯化水规格

Water Purity Specifications For the Laboratory, Cosmetic and Pharmaceutical Industries USP-ASTM-CAP-NCLLS Industrial Water Purification (800) CAL-WATER

The following is a list of water quality specifications from various authorities used by laboratories and the cosmetic and pharmaceutical industries to establish production standards for OQ, IQ, DQ and other quality control limits. The standards are used to specify the various pure water parameters to be measured for quality assurance.

Governing Authorities USP - (United States Pharmacopeia) ASTM - (American Society for Testing and Materials) CAP - (College of American Pathologists0 NCLLS - (National Committee for Clinical Laboratory Standards)

Water Purity Specifications In Use As of: August 24, 2007 USP 27 Pharmaceutical Grade Water Organics< 0.5 ppm Conductivity< 1.3 ms/cm@ 25oC in-line Measurement Endotoxins by LAL Purified Water No specification WFI< 0.2 EU/ml Bacteria (Guideline Only) Purified Water< 100 cfu/ml WFI< 10 cfu/100 ml

American Society for Testing and Materials (ASTM) ASTM Type: I II o 0.056 1.0 Conductivity (ms/cm@ 25 C) o 18 1 Resistivity@ 25 C Meg./cm Total Silica (mg/L) 3 3 Total Organic Carbon (mg/L) 100 50 Chlorides (mg/L) 1 5 Sodium (mg/L) 1 5 pH ASTM Subtype: A B Bacteria (cfu/100 ml) 1 10 Endotoxins (EU/ml)<0.03 0.25

III 0.25 4 500 200 10 10 C 1000 N/A

IV 5.0 0.2 50 50 5.0-8.0

美国药典27版纯化水标准

美国药典27版纯化水标准

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