Identification of impurities has become a major challenge for authorities of various pharmacopoeias worldwide as different impurity profiles of multi-source products have different standards. This is likely to throw open an opportunity for Indian research organisations and other industry bodies in the field of sale of impurities, noted an expert on the subject.
The Indian industry and research organisations would have an added opportunity in the sale of impurities, particularly those for which process has been developed for meeting licensing requirements and the technology is available in-house. Supply of impurities could be targeted towards pharmacopoeial authorities, regulators, customers, open sale to industry etc. Experts should keenly observe the conditions under which impurity is generated during the process and should elucidate structure after isolation or through use of hyphenated techniques. Further, they should identify the degradation route based on feedback from stress studies and should set conditions where the drug is converted rapidly to single product.
Delivering a lecture at the IDMA-APA PAC Convention 2006 at Mumbai last week, Dr. Saranjith Singh, professor and head, Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education & Research (NIPER), said, "Major drug exports to US and Europe are from East Asia and more than 80% of APIs used in European pharmacopoeia originated from India and China. As many as 10,000 plants in these countries supply APIs to the world with several having different process route for the same drug. This has caused different impurity profiles of multi-source products and it is difficult to identify impurities in select samples. Regulatory and pharmacopoeial expectations vary."
He said that European Pharmacopoeia Commission's latest key policy decisions to impurity control included that if the monograph did not provide suitable control for a new impurity, the manufacturer must develop a suitable test in the specification. The net result would increase the number of reference substances employed as assay standards with an assigned content.
"The problem of the availability of impurity and degradation product standards is already being faced by EO, USP etc. About 37 pharmacopoeias exist in the world and they are set to enter a whirlpool to ensure quality of drug substances and products," said Dr. Saranjith Singh.