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Wednesday, May 22, 2019

What is working standard in pharma?

Laboratory standard, In-house standard, and secondary standard are the names of the working standard. It can be utilized for the regular analytical evaluation of active pharmaceutical ingredients or dosage forms in conditions which high purity analytical reference standard is tricky to obtain. The working standard is typically specific to pharmaceutical drug development phase in which it is utilized. The purity of the working standard is usually very high; however, an analytical reference can be assigned without the same rigidity applied to the qualification of the reference standard. Working standards are frequently used widely in place of Analytical reference standard to preserve the material. Preferably, the working standard must be prepared by the normal synthetic route used to manufacture active pharmaceutical ingredients and should be subjected to further purification, if necessary.

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