Pharmaceutical Tests/ Cosmetics, Drugs and Medical Devicesservice

Service

Pharmaceutical Tests/
Cosmetics,
Drugs and Medical Devices

The JFRL performs tests based on the Japanese Pharmacopoeia (JP) and other foreign pharmacopoeias that specify basic quality tests for medical and pharmaceutical products. We also carry out stability tests (long-term storage tests, accelerated tests, and severe tests) on drug substances and drug products based on ICH Guidelines and JP.

Analysis items

    • Standards based testing for drugs (pharmaceutical ingredients and final products) and containers
    • Physicochemical, microbiological, and animal tests based on JP, Japanese Standards for Pharmaceutical Ingredients, Japanese Pharmaceutical Excipients, European Pharmacopoeia (EP), United-States Pharmacopoeia (USP), and various kinds of Japanese and international standards
    • Quantitative and qualitative analysis for cosmetics and quasi-drugs
    • Analysis for active and labeled ingredients and toxic impurities(arsenic, lead, methanol)
    • Stability tests (long-term, loading, accelerated conditions)
    • Standards-based tests for medical devices
    • Physicochemical test , Bacterial endotoxins test , Sterility test , Biological test
    • Microbial tests
    • Microbial limit test , Sterility test , Preservatives-effectiveness test , Bactericidal efficacy test
    • Biological safety tests under GLP
    • Cytotoxicity test , Acute systemic toxicity test , Repeated dose toxicity test , Irritation test , Skin sensitization test , Genotoxicity test ,Implantation test

Certification and accreditation examinations

  • GMP compliance inspections concerning drugs based on the Pharmaceutical Affairs Law:Complied. GMP on drugs and QMS on medical devices.
    [Physicochemical test] Tama, Chitose and Saito Laboratories
    [Tests on animals and cultured cells] Chitose Laboratory
  • GLP compliance inspections concerning medical devices:Complied, “A” in the Chitose Laboratory.

Representative apparatus/
facility

  • GC-MS
  • LC-MS
  • Ion chromatography
  • AAS
  • ICP
  • ICP-MS
  • Capillary electrophoresis apparatus
  • FTIR
  • Light obscuration particle counter
  • Isolator
  • Stability test facility and apparatus:
    Constant temperature room, Constant temperature and humidity room, Photo stability chamber
  • Other facilities:
    Centralized monitoring system for stability test, Emergency power generating system, Constant temperature and humidity chamber
  • in vitro and in vivo Testing facility