Working Standards

High Quality API Working Standards are used to help ensure the identity, potency, quality and purity of drug products and drug substances. This is accomplished by analyzing the substance against its qualified reference standard, so the accuracy of reference materials is essential to manufacture quality APIs.

Working Standards can be compendial, referred to as Primary Reference Standard, or a highly characterized in-house standard or a Secondary Reference Standard. Primary Working Standards can be obtained from the standards-setting Pharmacopeias, such as the USP or EP.

At Chromato Scientific, we regularly synthesize and qualify materials as Working Standards for a variety of projects, such as the following:

• To quantitatively determine the producy assay.
• To detect impurities in the sample.
• For releasing raw materials.
• For in-process monitoring.
• As a retention time reference marker.
• For stability studies.