Method Development

Method Development
Product Description

We are specialist in the method development of analytical methods for analysis of API, Final Drug Products or low level impurities. Usually followed by full validation in accordance to ICH guidelines.

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Brightlabs

  • NL
  • 2021
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service
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Categories
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Specifications
  • Supplied from
    Netherlands
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Sales Markets
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Brightlabs

  • NL
  • 2021
    On CPHI since
  • 2
    Certificates
  • 25 - 49
    Employees
Company types
Contract Service
View company profile

More Products from Brightlabs (3)

  • Elemental Impurities

    Product Elemental Impurities

    Brightlabs has in-house validated methods for the analysis of elemental impurities in accordance to ICH-Q3D. Brightlabs has a unique approach for ICHQ3D, which guarantees quick turnaround times at reduced cost
  • Herbal Drugs Analysis

    Product Herbal Drugs Analysis

    Since 2018 Brightlabs possesses an opium exemption from the BMC (Bureau for Medicinal Cannabis), for the analysis of cannabis and related products. The combination of this opium exemption, combined with our GMP accreditation, makes Brightlabs an important partner for the analysis of cannabis and related ma...
  • Nitrosamine Analysis

    Product Nitrosamine Analysis

    In response to nitrosamines present in pharmaceutical products, the European Medical Agency (EMA) and the US Food and Drug Administration (US FDA) have published requirements and limits related to nitrosamine contaminants. Therefore Brightlabs has developed and validated multiple methods to determine low l...

Brightlabs resources (1)

  • NDSRI analysis

    Brochure NDSRI analysis

    Brightlabs has developed and validated multiple methods (GC-MS/MS & LC-MS/MS) to determine low level concentrations of Nitrosamines and NDSRIs in Drug Products