5-Batch Analysis

[prashantnaik07]

Can anyone please explain it to me what is 5-Batch Analysis and How it is performed

Thanx

[Chandresh K. Soni]

dear prashant
5-batch analysis is the basic requirement for GLP Registration. For Example if 5 batches of your product has been analysed by any GLP certifird lab and the datas will submit the regulatory authority. then these datas are exceptable to all over world and not required re analysis.

[prashantnaik07]

Hi
Mr. C K.Soni

Thanx for replyn 2 my question can you please suggest m some guideline if any that i should follow if i want to carry out the 5 Batch Analysis and other analytical chemistry activities which are to be performed in a GLP Laboratory Environment

[Pragmatist3]

Hi
Mr. C K.Soni

Thanx for replyn 2 my question can you please suggest m some guideline if any that i should follow if i want to carry out the 5 Batch Analysis and other analytical chemistry activities which are to be performed in a GLP Laboratory Environment

Below is the EPA guideline, also known as a "preliminary analysis".

http://www.epa.gov/opptsfrs/publication ... 0-1700.pdf

Simply confirming the purity of your ai in 5 representative production lots is the easy part of a 5-batch analysis. The identification of impurities at >0.1% w:w is where the studies can become rather complicated (especially when the client hasn't a clue what they might be).