Nonclinical and Clinical ServicesWe have renewed our web page for Nonclinical Services. Please find the link hereWe have renewed our web page for Chemical Substance Management. Please find the link here

Nonclinical Studies

The Toxicological Science Division serves to perform nonclinical studies by taking full advantages of a vast array of techniques and renowned reliability that the former Mitsubishi Chemical Safety Institute Ltd. (MSI) had acquired through its broad range of accumulated experience.

Tests on Pharmaceuticals and Agrochemicals

Stability and Specification Studies

We perform analyses in compliance with the pharmaceutical GLP employing a seasoned staff of talented scientists with state-of-the-art test facilities based on our highly developed technology and the confidence we have cultivated over our years of experience in organic and inorganic analytical chemistry, physical property analysis, and GLP compliance.
In addition to our broad range of experience and achievements in specification testing based on JP, USP, and EP standards, we have a selection of storage stability tests, including accelerated tests, stress tests, and photostability tests for drug substance or drug products in reference to ICH guidelines. We perform studies on the basis of reliability standards in compliance with the pharmaceutical GLP. We are now delighted to announce that we can also provide studies under reliability standards in full compliance with GMP.

Stability and Specification Studies

  • Stability Tests for Drug Substance and Drug Products (GMP, GLP)
    • Intermediate Tests
    • Accelerated Tests
    • Stress Tests
    • Photostability Tests (Light sources; D65, white fluorescent light, near-ultraviolet fluorescent light)
  • Characteristic Analysis and Stability Tests
    • Property
    • Purity
    • Content
  • Specification Analysis (JP, JIS, USP, EP)
    • Property
    • Identification Tests
    • Characteristic Values Including pH, Melting Point, Optical Rotation, and Viscosity
    • Purity Tests (Heavy Metal, Arsenic, Related Substances, etc.)
    • Quantitative Determination (Titration, UV, HPLC, GC, etc.)
  • Pharmaceutical Analysis
    • Dissolution Tests
    • Disintegration Tests
    • Grain Size Tests
    • Friability Tests
    • Hardness Tests
    • Content Tests, Content Uniformity Tests
  • Compatibility Tests
    • Injections
    • Powder Formulations, Granules, etc.
  • Others
    • Analytical Method Validations

Major Equipment and Instrument

  • Stability Chamber
  • Photostability Chamber
  • Intensive Data Monitoring System for Stability Testing
  • Dissolution Tester (6-Shaft, Auto Sampler)
  • High Performance Liquid Chromatography
  • Gas Chromatography
  • And much more ...a full selection of state-of-the-art analytical instruments

Validation of Storage Facility/Equipment

  • Maintenance/Control of stability chamber and photostability chamber with intensive data monitoring system
  • Qualification of Storage Facility/Equipment (IQ, OQ, PQ)
    • Operated by the supplier, confirmed by the user
    • Confirmation of precision and distribution (temperature, humidity, lighting intensity) of each instrument
    • Confirmation of system functions (recording and alarming of deviations, etc.)
  • Calibration
    • Regular inspection of each instrument and system by suppliers (annually)
  • Traceability
    • Use of instrument, apparatus, and standards complying with Japan Calibration Service System
  • Inspections
    • Pre-run Inspection: Confirmation of deviations, temperature, humidity, lighting intensity, sample conditions, and system failure
    • Regular inspection: Detailed inspection (by the user), cleaning, and alarm tests once every 3 months
    • Annual inspection: Regular inspection of each instrument and system by the suppliers

All of our research and studies are in strict adherence to the laws concerning protection and management of animals with full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.

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