Reference standard not available in IPC

Quality Control
#1

Hello everyone,
we are manufacturing one of the product as per IP grade but there is no reference standard available in IPC for these particular product. In that condition how will you release the batches???. For these product, assay by HPLC test is mandatory. So during the testing of these product which reference standard is used for the assay test and how to release the batches???

Please suggest

#2

We can procure the standard from vendor and qualify our material as standard by using vendor standard as reference standard. After completion of analys if it is ok prepare the material as standard and fill the vials. One more test Confirm the characterization of the material by using NMR or Mass spectroscopy.
Or

If Usp or Ph. Eur reference standards available qualify the material against available reference standard lf the tests ok we can prepare our
material also as standard.

#3

thanks for reply…but standard procure from vendor as reference standard it is regulatory accepted or not???. These product reference standard are not available in USP,BP/EP

#4

We can procure the standards from vendor the regulatory will accept .

#5

thanks…