In an effort to offer quality international laboratory services for the pharmaceutical industry in the country, the National Institute of Pharmaceutical Education and Research (NIPER) has set the most sophisticated LC-NMR and LC-MS-TOF instruments for stability testing and impurity profiling.
The instruments, to offer impurity tests as per the current most regulated drug safety standards, has been imported from Japan and installed using Rs 5 crore grant from the Pharmaceutical Research Development Programme (PRDP) provided by the central government. The Pharmaceutical Research Development Programme (PRDP) grant was provided through the Ministry of Chemicals and Fertilisers to strengthen the impurity profiling facilities at the premier institute, according to NIPER officials.
"The two instruments are the most sophisticated tools, as of today, for the characterization of impurities in pharmaceuticals, without involving their isolation. These can be also used for prediction, detection and characterization of metabolites," averred Dr Saranjith Singh, professor and head, Department of Pharmaceutical Analysis, NIPER.
With the setting up of the new instruments, the lab is able to render service with world class standards and has received inquiries even from China to prepare impurity profiles. The NIPER has received inquiries from a Chinese company to develop impurity profile of ampicillin and the lab has asked for a timeline of two months for synthesis and development of the profile. The lab officials are waiting for reply from the Chinese firm for further procedures.
Currently, a few companies like Dr Reddy's Laboratory and Nicholas Piramal have installed LC-NMR and LC-MS-TOF instruments at their in-house facility. However, the NIPER lab will demand specific pre-requirements from the individual firm for the impurity profile and stability checking, prior to delivery of its service.
"We have already commenced development of almost five projects using the new instruments and more projects from the entire spectrum of the industry are in pipeline," said Dr Singh.
The lab is currently handling around 30 stability testing and impurity profiling projects from the industry with major clients including Ranbaxy Laboratories, Mohali, Elder Pharmaceutical Ltd, Mumbai, Cadila Pharmaceuticals, Ahmedabad, Bharat Serums and Vaccines Ltd, Mumbai, DSM Anti-Infectives Ltd, Toansa, Flamingo Pharmaceutical Ltd., Mumbai and Strides Acrolab Ltd, Bangalore. The lab also has a number of overseas clients for the stability test and impurity profiling like Morvek Biochemicals, USA, Shiono Chemical Co Ltd, Japan, HFL Ltd, UK, Aldo International Ltd, Canada, Phapros Tbk, Indonesia and Stiefel Research Institute, NY, USA.