Analytical reference standard is also called gold standard or primary standard. The analytical reference standard is defined as a lot of drug substance; its purity is independently established and accepted by other standards. An Analytical Reference Standard is used to calculate the active ingredients of the drug substance or product.
Content is as accurate as >99.5% achievable with reasonable effort. The material obtained is fully characterized guaranteeing its quality, identity, precision and resistance.
Structural identities are achieved by separate spectral interpretation and, on a weight basis, each impurity is determined to establish full mass balance accountability. Additionally, the inherent stability of the material must be fully understood, after all, analytical reference standards must complete all purity and assay identities.
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