Pharmaceutical Secondary Certified Reference
Materials (CRMs) provide pharmaceutical
laboratories and manufacturers with a convenient
and cost-effective alternative to making in-house
working standards.
Using these commercially available Secondary CRMs
will reduce the need to spend time and resources
preparing in-house working standards.
Our Secondary Standards are Certified Reference
Materials (CRMs) manufactured under the scope of
ISO 17034 and tested in an ISO/IEC 17025
accredited testing lab. Comprehensive Certificates of
Analysis demonstrate traceability to USP, EP and/or
BP primary standards (where available). In addition,
an independent certified purity value is provided.
This allows these Secondary CRMs to be used as
reference materials for quantitative uses in a variety
of applications.
The US Food and Drug Administration (FDA) and the
European Pharmacopoeia (EP) both recognize the use
of secondary standards or working standards which
are established with reference to the corresponding
primary standard (references available on request).
The certificate of analysis for Pharmaceutical Secondary CRMs typically contains:
You can view and download an example COA for any pharmaceutical secondary standard
at SigmaAldrich.com/pharmastandards.
Select your standard of interest, scroll down
to the “Documentation” section, and click “View Sample COA.
The values on the certificate are always traceable
to the current Pharmacopeial lots (where
available). If a valid Pharmacopeial lot changes,
our corresponding Pharmaceutical Secondary CRM
will be re-certified with traceability to the new lot.
Then, a new certificate will be made available on
our website. For this reason, the valid certificate
should always be downloaded from the website
prior to use of the material. To do this, find your
product at SigmaAldrich.com using the part
number or via our standards explorer (located at
SigmaAldrich.com/reference-materials;
bottom of the page) and scroll down to the
Documentation section. Here you can enter the lot
number of your standard.
