Keep in mind

Read the test name and its units before interpreting the number.

Different questions, different tests

Identity, assay and impurities are separate elements of a specification. A percentage headed ‘purity’ should not be treated as the quantity of material in a container. Read the method and the laboratory’s explanation of what the result represents.

Read the complete specification

Look for the test procedure and any acceptance criteria. A single favourable result does not establish that every relevant quality attribute has been assessed. Keep conclusions within the scope of the tests actually reported.

Read the original source

EMA / ICH Q6A — test procedures and acceptance criteria ↗ (opens in a new tab)

These guides explain research concepts. They do not provide individual medical advice or establish the status of any particular product.