exact matching of CCs (validation’s and study’s) [Regulatives / Guidelines]

posted by sushil.pimpare – India, 2017-05-31 15:46 (2810 d 18:31 ago) – Posting: # 17432
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Thank you for your reply.
Also I wanted to confirm wheteher Below reason for change in CC is acceptable or not?
Nominal concentrations obtained on the basis of weight of reference standard and purity of reference standard used during method validation and subject sample analysis and since these values, i.e. purity, water content, weight of standard etc., could vary slightly from one preparation to another, there is bound to be some difference in nominal concentrations during experiments and theoretical values. These differences are very small (less than 2.0%) and do not necessitate any partial validation.

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