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We founded “Pharmaceutical Analysis Center”, which is fully equipped with HPLC, UPLC, GC and other highly standard instruments and a sampling room. We perform quality tests to choose new generic APIs, establish specifications, and quality tests of imported APIs. We also manage various tests requested by Licensed Marketing Approval Holders.

  • Service for Development
    We have well-equipped laboratories with the latest models　of various (analytical) equipment such as HPLC, UPLC and GC on the second floor of our Pharmaceutical Analysis Center where our competent analysts perform the following services:
    ・Quality tests and establishment of specifications to select new generic APIs
    ・Modification of specifications of APIs which have already been used in approved dosage forms when they are added with new dosage forms or partly changed
    ・Tests requested by Licensed Marketing Approval Holders for new generic drugs’ approval
  • Routine Service
    We have another laboratory on the 1st floor of the Center to offer the following routine services. Regarding the service for development as well, experts examine APIs’ specifications with equipment　as HPLC, GC and DSC to confirm the quality of imported APIs by ourselves.
    ・Quality tests and quality control of imported APIs
    ・Validation
    ・Quality tests of APIs requested by Licensed Marketing Approval Holders
    For sampling, which is a part of quality test, we exclusively set a sampling room to avoid contamination or cross-contamination. Particularly, regarding the safety of the employees and environment, sampling of highly activated APIs is done with an isolator system. And after that, we weigh and prepare sample solution for instrumental analysis in a safety cabinet.
Main Test Equipment

HPLC&UPLC

ISOLATOR

GC