text.skipToContent text.skipToNavigation

Primary reference standards

LGC primary standards for APIs and excipients

LGC produces and certifies one of the largest collections of primary reference standards under the QUANT brand. They fulfill all ICH, FDA and other regulatory body requirements for universal qualitative and quantitative pharmaceutical quality control, as well as all the relevant metrological requirements from ISO guidelines.

What is a primary reference standard?

According to definitions by ICH (Guideline Q7), FDA and WHO, primary reference standards of active pharmaceutical ingredients stand at the top (primary position) of any given classification or comparison chain of pharmaceutical standards for active ingredients, based on the methods that are used to characterise them. The term “primary standard” is also used within ISO metrology definitions to describe a high quality range of reference materials. Pharmaceutical primary standards are reference standards which are established by a thorough qualitative and in most cases quantitative characterisation of the candidate material. Their assay value (or identity only) has been established without the need to compare it to any other material of the same structure.

Primary reference standards
Advanced-Search.jpg

Advanced
search

Refine your
search

null

Online Ordering made easy

null

Sign up to our email newsletter

null

Catalogues

Punchout session timeout warning

Your punchout session will expire in 1 min 59 sec.

Select "Continue session" to extend your session.