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 Yand

link 8.04.2009 21:55 
Subject: sink condition
sink condition

Validation of analytical method for determination of dissolution was
performed in accordance with the approved protocol for the parameters including -
Specificity, Linearity & Range, Accuracy (Recovery), Precision - Method Precision
(Repeatability), Intermediate Precision (Ruggedness), Robustness, Solution stability,
Filter media interference and sink condition & System suitability.

thanks

 алешаBG

link 9.04.2009 4:42 
если поможет:
Q What is sink condition? How is it performed on tablets and pooled samples? Which is the importance of the sink condition in the development of dissolution tests?
A Sink conditions describe a dissolution system that is sufficiently dilute so that the dissolution process is not impeded by approach to saturation of the compound of interest. Sink conditions affect the production of the sample but not the condition of the solution upon sampling.Thus, any concerns regarding the subsequent pooling of samples are unnecessary. The only physical measurement required is that of solubility at the test temperature. Once the solubility is known, the volume of medium or the acceptability of a particular medium can be determined.Typically, sink conditions are considered to exist if, at the dissolution of 100% of the highest strength of the product to be tested, a concentration of not more than 1/3 of saturation will be achieved.

 Yand

link 9.04.2009 20:59 
Все равно не понимаю как одним словом сказать(((

 

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