Discussion on the purified water inspection methods in the Chinese Pharmacopoeia of edition 2010

LIU Qiang; SUN Zhiguo; CHEN Yi; CHEN Qi; HUANG Hualin; GAO Jing

doi:10.3969/j.issn.1006-0111.2016.03.015

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Objective To modify the purified water analysis methods in the Chinese Pharmacopoeia (Vol.Ⅱ, Edition 2010), and mainly focus on the pH value determination, analysis of nitrate and nitrite, and the inspection of microorganism. Methods The usage of regents and colorimetric tubes in the analysis of nitrate and nitrite were inquired, the feasibility of plating culture used in the inspection of microorganism were proposed, and the suggestion of using more instrumental analysis instead of titrimetric analysis in the purified water inspection wasraised. Results The choice of colormetric apparatus and the precision of the regents were explicit. The plating method was better in convenience and reliability than membrane-filter procedure during the microorganism inspection. Instrumental analysis is the trend of purified water inspection and deserved to be recommended. Conclusion Based on our own and others' studies, the methods of impurity analysis are improved, which might be accepted in the revision of Chinese Pharmacopoeia in future.

Discussion on the purified water inspection methods in the Chinese Pharmacopoeia of edition 2010

1. School of Pharmacy, Second Military Medical University, Shanghai 200433, China;No.68315 Troops of PLA, Zhangye 734000, China

2. School of Pharmacy, Second Military Medical University, Shanghai 200433, China

Received Date: 2015-01-15

Rev Recd Date: 2015-05-15

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Abstract: Objective To modify the purified water analysis methods in the Chinese Pharmacopoeia (Vol.Ⅱ, Edition 2010), and mainly focus on the pH value determination, analysis of nitrate and nitrite, and the inspection of microorganism. Methods The usage of regents and colorimetric tubes in the analysis of nitrate and nitrite were inquired, the feasibility of plating culture used in the inspection of microorganism were proposed, and the suggestion of using more instrumental analysis instead of titrimetric analysis in the purified water inspection wasraised. Results The choice of colormetric apparatus and the precision of the regents were explicit. The plating method was better in convenience and reliability than membrane-filter procedure during the microorganism inspection. Instrumental analysis is the trend of purified water inspection and deserved to be recommended. Conclusion Based on our own and others' studies, the methods of impurity analysis are improved, which might be accepted in the revision of Chinese Pharmacopoeia in future.

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Reference (9)

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Discussion on the purified water inspection methods in the Chinese Pharmacopoeia of edition 2010

doi: 10.3969/j.issn.1006-0111.2016.03.015

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