Hi sir Some times impurities not available and due time restriction we approve first protocol and impurities are available after in that case purity of impurities not available during protocol preparation.
Hai sir very nice explanation and i am implementing most of the things that you explained in my lab Thanks for building confidence and guidance and i have some doubts please clarify me 1. Sample reconciliation for MV activity required or not required ? 2. Is their any procedure to include in MV if something is missed in MV protocol and found during execution ? 3. For method verification what are the parameters need to consider ? 4. for dissolution method robustness with respect to dissolution parameters (variation in RPM, variation in MEDIA VOLUME and media temperature) required or not require?
As we use finish tablets for dissolution test. While performing validation. How I use 1st is it same for both assay and dissolution accuracy for different concentration of finished tablet. As we take one tablet for each disolution vessel. for validation purpose. How practically I use the finish tablet for the purpose
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Really good.
Sir how to prepare method qualification protocol for silver staining.....😢😢
Hi sir
Some times impurities not available and due time restriction we approve first protocol and impurities are available after in that case purity of impurities not available during protocol preparation.
Thanks for sharing the knowledge sir
Nicely explained sir, thank you
In R&D development stage spec and stp may not be available at the time of validation how to proceed? Please explain sir
Explained your very well sir
Thank you for explaining sir
It's very helpful
Hai sir
very nice explanation and i am implementing most of the things that you explained in my lab
Thanks for building confidence and guidance
and i have some doubts please clarify me
1. Sample reconciliation for MV activity required or not required ?
2. Is their any procedure to include in MV if something is missed in MV protocol and found during execution ?
3. For method verification what are the parameters need to consider ?
4. for dissolution method robustness with respect to dissolution parameters (variation in RPM, variation in MEDIA VOLUME and media temperature) required or not require?
Point 4 required
Hi sir how to calculate stability failure rate in pharma
Thank-you very much for sharing this
Excellent Sir
As we use finish tablets for dissolution test. While performing validation. How I use
1st is it same for both assay and dissolution accuracy for different concentration of finished tablet. As we take one tablet for each disolution vessel. for validation purpose.
How practically I use the finish tablet for the purpose
thank you sir
Thank u so much sir
Thank you so much sir