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Registerexact matching of CCs (validation’s and study’s) [Regulatives / Guidelines]
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.
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.
Complete thread:
- change in CC range sushil.pimpare 2017-05-31 09:31
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- exact matching of CCs (validation’s and study’s) Helmut 2017-05-31 12:41
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s) ElMaestro 2017-05-31 14:11
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 15:38
- exact matching of CCs (validation’s and study’s) sushil.pimpare 2017-05-31 14:01
- exact matching of CCs (validation’s and study’s)sushil.pimpare 2017-05-31 13:46
- Sapere aude! Helmut 2017-05-31 14:46
- exact matching of CCs (validation’s and study’s) nobody 2017-05-31 13:43
- exact matching of CCs (validation’s and study’s) Helmut 2017-05-31 12:41
Ing. Helmut Schütz