Primary API reference standards

Primary API reference standards
Product Description

Mikromol reference standards for Active Pharmaceutical Ingredients (APIs) are primary quantitative standards – the majority accredited to ISO 17034 and designed to ensure the highest analytical accuracy and reliability. Their intended use is for potency assessments, drug substance and drug product release testing, therefore they have a tight target measurement uncertainty – M(u)- of 0.5 per cent.

Many of our API reference standards fulfil International Council for Harmonisation (ICH), Food and Drug Administration (FDA) and other regulatory requirements for pharmaceutical quality control. They also come with detailed COAs, including identity checks by several qualitative techniques. Assay information is usually provided by an ISO/IEC 17025 accredited technique, such as 100% mass balance, and is confirmed by a second independent method (e.g. Quantitative Nuclear Magnetic Resonance Spectroscopy (qNMR).

LGC

  • GB
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other

LGC

  • GB
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other

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LGC resources (4)