Let me know about this query
We are performing dissolution physical parameteres like rpm, Wobling, Centering, Distance, Temperature for every 3 months interval.
My query is if all the above parameters are wihtin the limit,
Calibration of Prednisone and Salicylic Aicd is required or not.
Dear Veerabhadra Rao
This is required and deviating form this will be very serious enough if are working for regulated market.
This must be performed after eveery 6 months and after any manitainance job.
Regards
Dear Veerabhadra Rao,
The purpose of chemical testing, is to assure in a set of standard operating conditions,the instruement should meet release criteria for a particular lot.
In case of physical parameter testing, you are only cross checking a individual physical parameter agianst a reference.
Finally Only Chemical testing can ensure, that in real time situations, how far the performance of Disso apparatus.
Hope this answers your queries.
Dissolution is the process by which a solid or liquid forms a homogeneous mixture with a solvent (solution). This can be explained as a breakdown of the crystal lattice into individual ions, atoms or molecules and their transport into the solvent.
Dissolution testing is widely used in the pharmaceutical industry for optimization of formulation and quality control.
mechanical calibration should be followed by PVT using reference standard tablets.
It is must along with physical parameters. You can reduce the frequency say it can be done anually. As frequency for any calibration is not mendatory. what ever frequency framed has to be justified.
If you are not into regulated buisness you can use reference standards issued by IFPRESS. (Klenzaids); which are very cheap by cost and acceptable by indian authorities.