including results of Potency by HPLC , NMR & XRPD data.
whenever there is requirement of w.std preparation first we
have get API rawmaterial from warehouse & we check assay ,
water content or LOD & Related substances aganist reference
std . Some times we are doing analysis in duplicate & get
mean value.then we decide final assay or potency value &
it's validity one year
THAN 60 AT THAT PARTICULAR CONCENTRATION AS WEL AS NO
3 :: Suppose we prepared pH buffer solution in lab.and calibrate against NIST solution, and same shall going to used upto 30 days. is it possible to stable pH and apperance? suggest?pH OF THE BUFFER SOLUTION WILL BE CHANGE, AS DUE TO PRESENCE OF NITROGEN CONTAINING SUBSTANCES AND ALSO DUE TO MICROBIAL GROWTH. BUT IF STORED AT 4 DEGREE CENTI. IT MAY USED TO SOME EXTENT.
completion of reaction, or the unreacted portion present in
the product. RS testing help us to identify the adequate
quantitiy of these by-products or unreacted part.
More over RS help us during the stability study to know any
significant change in the nature of product during long
storage in various climatic conditions