Excipient and Concomitant Component Standards

Excipient and Concomitant Component Standards
Product Description

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 detailed COAs featuring identity, purity, and assay data. Although there is not yet an official guideline for excipient testing, our excipient standards are manufactured according to the same stringent requirements as our API standards, as excipients are a significant component of the drug product being released for human consumption. We also provide the impurity and concomitant substance standards required to assess an excipient’s quality and performance. The analysis of concomitant substances is the main challenge in achieving excipient quality control, as they are often a natural part of the excipient and can also influence its performance significantly. 

Mikromol offers high-quality concomitant component standards to enable you to set meaningful excipient specifications.

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LGC Standards

  • US
  • 2017
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other
View company profile
Categories
more categories Show less

LGC Standards

  • US
  • 2017
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Other
View company profile

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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