For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

Analytical science

Identity, purity and content: three different questions

Why three frequently confused terms require different analytical approaches.

Why three frequently confused terms require different analytical approaches.

Identity

An identity test asks whether the principal signal is consistent with the expected substance. It may use mass, retention time or another characteristic compared with a standard. Identity is a categorical question and does not answer how much material is present.

Purity

Purity often describes the relative distribution of signals in a particular method. It depends on what the method detects and how components respond. A high relative percentage does not exclude substances that are not visible to the selected detector.

Content

Content is a quantitative determination relative to a known standard and stated basis, such as mass or dry substance. It requires suitable calibration and accuracy control. HPLC area percentage should therefore not automatically be presented as the amount of material.

Sources and further reading

  1. ICH Q2(R2) — Validation of Analytical Procedures
  2. EMA / ICH Q14 — Analytical procedure development
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For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

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