Batches are tested by an outside laboratory. Most results on a certificate come from two methods, RP-HPLC-UV and ESI-MS. The tests run on a batch are listed on its certificate.
Release path
The release steps, the tests on the published certificates and the testing laboratory are on the quality page.
Reversed-phase liquid chromatography with UV detection
The sample runs through a C18 column, which separates the active ingredient from related substances. A UV detector at 220 nm measures each of them as it leaves the column. The size of the main peak against a reference standard gives the content, and its share of all peaks gives the purity.
Reported on the certificate
Electrospray ionisation mass spectrometry
The active ingredient is ionised and its molecular mass is measured. The certificate reports identity as a match between the measured and the expected mass, within the tolerance printed beside the method.
Reported on the certificate
Quality controls
The measured mass of the active ingredient matches the formulation record.
Content and related substances are reported against the specification printed on the certificate.
Each certificate belongs to one batch. The unit codes from that batch link to it.
Only certificates with an overall pass are published.
Result status
Each test on a certificate is printed with its specification and its result side by side.
The result is within the specification printed for that test.
The result is outside the specification. A failed test makes the certificate’s overall result a fail, and the certificate is not published.
Next
Verify a unit code to see its linked Certificate of Analysis, or read the FAQ for common questions about verification results.
