The analytical reference standard also called as the gold standard or primary standard. The analytical reference standard is defined as a batch of drug substance; its purity is established independently and accepted in the context of further standards. An analytical reference standard is used to calculate the active ingredients in the drug product or drug substance. Content is the highest accuracy with > 99.5% that can be gotten with sensible effort. The obtained material is fully characterized to assuring its quality, identity, accuracy, and strength, Structural identities are done through separate spectral interpretation and on the weight basis, every impurity determined to establish full mass balance liability. In addition, the inherent stability of the material should be fully understood, After all, the analytical reference standards have to complete all the identities purity, and assay.
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