• Home
  • LGC Standards
  • Active Pharmaceutical Ingredient (API) Primary Reference Standards

Active Pharmaceutical Ingredient (API) Primary Reference Standards

Active Pharmaceutical Ingredient (API) Primary 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, calibrations, 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 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)).

Read more Show less

LGC Standards

  • Country/Region:
    United States
  • On CPHI since:
    2017
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
Other
View company profile
Categories
more categories Show less

LGC Standards

  • Country/Region:
    United States
  • On CPHI since:
    2017
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
Other
View company profile

More Products from LGC Standards (2)

  • Custom Reference Standards

    Product Custom Reference Standards

    Creating pharmaceutical reference standards to customer specification has always been at the heart of the Mikromol business.

    We understand that you are constantly discovering new actives and impurities of interest – each year, our dedicated, highly-qualified customs team produces severa...
  • Excipient and Concomitant Component Standards

    Product Excipient and Concomitant Component Standards

    Designed to deliver the highest accuracy and reliability, Mikromol excipient standards are primary quantitative standards that are suitable for calibration, assay development or as working standards. Most of the 170+ excipient products in our range are ISO 17034 accredited, and all are supplied with de...

LGC Standards resources (1)

  • LGC in Luckenwalde

    Video LGC in Luckenwalde

    At our reference standards manufacturing site in Luckenwalde, Germany, we have produced high quality API, impurity and excipient reference standards for the pharmaceutical industry for over 28 years. These reference standards are used by our customers for method development and validation, as well as in critical quality control applications. We're accredited to ISO/IEC 17025 and GMP, and a range of our standards are manufactured under ISO 17034. We are experts in a wide range of analytical techniques – from NMR through to HRMS, UPLC and Elemental Analysis. Our expansive site is also the heart of LGC's global distribution network. From here we supply high quality reference standards to thousands of customers worldwide.  Enjoy this view inside the workings of our Luckenwalde site!
    2022-04-25