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Eurofins Japan >> Eurofins Biopharma Product Testing Kyoto >> Services

Services

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Eurofins Analytical Science Laboratories, Inc. provides the following testing services of pharmaceuticals.

 

Method Development & Quality Testing
  • We provide services for low-molecule pharmaceuticals and also biopharmaceuticals such as antibodies.
  • We offer services of method development and validation to prepare filing.
  • We perform various testing in a timely manner.

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Microbiological Testing
  • We offer services of method development and validation for any dosage form.
  • We support method transfer to any other laboratories.

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Impurity Testing
  • We offer services of Residual Solvents / Impurities (ICH-Q3C), and Trace Metals (ICH-Q3D) testing.
  • We offer services of Extractables & Leachables testing (ICH-Q3E to be adopted).
  • We offer nitrosamine testing (NDMA,NDEA, and NMBA etc.).

Details

Formulation Development Support

We support formulation development by non-destructive analysis and imaging analysis.

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Foreign Matter Analysis

We analyze foreign matters in tablets and insoluble matters in liquids.

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Stability Testing

We offer stability testing under various conditions.

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Reference Standards Management

We comprehensively support quality control, storage management, and shipment of reference standards. (Purchasing is negotiable.)

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Biosafety Testing

We provide mycoplasma testing and viral clearance studies for biopharmaceuticals.

Details

Others
  • We provide testing services under quality system management in compliance
    with Pharmacopoeia (JP, USP, EP).
  • We utilize the global network of Eurofins companies.

 

How to Order