Sir can you please say if we are using only API for accuracy parameter directly we can inject as such standard at different concentration such as 50-150%
Respected Sir, We are validating the HPLC method for quantitative analysis of single active standard compound in plant. So, Sir for accuracy study this will fall under the category of accuracy for assay of drug substance or accuracy for assay of drug product? Thanks and Regards
How to arrive self life spec level and release level for impurities. 0.2% and 0.5% is default or vary with product to product and impurity to impurity. REPLY PLEASE 🙏🙏🙏🙏🙏🙏
thanks very much , cleared my doubts , very helpful
Sir can you please say if we are using only API for accuracy parameter directly we can inject as such standard at different concentration such as 50-150%
Please can you make video on combine approach for accuracy and precision
Sir give different between purity,area normalization,potancy, qualitative and quantitative give difenation or principle
Respected Sir,
We are validating the HPLC method for quantitative analysis of single active standard compound in plant. So, Sir for accuracy study this will fall under the category of accuracy for assay of drug substance or accuracy for assay of drug product?
Thanks and Regards
How to arrive self life spec level and release level for impurities. 0.2% and 0.5% is default or vary with product to product and impurity to impurity. REPLY PLEASE 🙏🙏🙏🙏🙏🙏
Good explanation
Sir why we select 50,100,150% level in accuracy method validation
Why assay test acceptance criteria is 98 to 102% ??
Sir please make a video on potentiometer
Sir please explain how to determine LOQ level for RS Test
Will make video on this topic soon
For assay 98 to 102% you have told . Can you say the guideline. I will refer as per usp and ich
Dissolution method validation
Dear sir 20% of 30% not 20 % substrate in 30%
85 to115 percentage recovery guidelines anything