What an Analytical Record Does and Does Not Establish

Keep the questions separate

A catalog listing identifies a material and nominal size. An analytical report describes tests performed on a submitted sample. Before using a result, identify which question the method addresses and what the laboratory says the result means.

The terms identity, purity, and measured content should not be used interchangeably. A percentage, a mass result, and an identity finding may appear together, but each needs its own method and interpretation.

Identity

An identity analysis concerns whether a sample is consistent with a stated material according to the method used. Read the exact conclusion and any limitations. Do not assume that a catalog code, label, or purity percentage establishes analytical identity.

If sequence, formula, salt form, or another specification is required, obtain an applicable source record. Details copied from a different supplier are not documentation for the supplied sample.

Purity

A reported purity value must be understood in the context of its method, calculation, sample, and qualifications. The number alone does not describe every possible impurity or every property of a material.

Use the laboratory's report to identify what the percentage represents. Avoid turning a limited result into a claim about safety, sterility, or performance that was not evaluated.

Nominal amount and measured content

The nominal amount is the listed or labeled amount. Measured content is a result of an analysis when that analysis is present. Keep the label value and analytical result separate in receiving records.

For a blend, a total nominal amount does not tell you what was measured for each component. Check whether the report addresses the blend, individual components, or a narrower analytical question.

Questions not answered by the report

A COA does not automatically establish sterility, the properties of every container in a lot, clinical suitability, or regulatory approval. A test that does not appear in the report should not be implied by a general testing claim.

When your laboratory needs an additional specification or analysis, ask the supplier for the relevant document. Mark the field as unavailable or unresolved if no supporting record has been provided.

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