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).

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LGC Standards

  • GB
  • 2015
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other
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Categories
more categories Show less

LGC Standards

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

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LGC Standards resources (2)

  • Why ISO 17034?

    News Why ISO 17034?

    As a provider of reference materials for a broad range of scientific industries, many of LGC Standards’ products are manufactured according to the International Organisation for Standardisation’s accreditation scheme for reference material providers, ISO 17034.

    2 Oct 2020
  • LGC Mikromol brochure

    Brochure LGC Mikromol brochure

    Primary Pharmaceutical Reference Standards and Reference Material Services