Drug reference standard

Drug Reference Standard

A Drug Reference Standard is a standardized substance which is used as a measurement base for similar substances. Wherever possible, it is identical to the drug substance in a medicinal product. Drug Reference Standards are highly characterized physical specimens used in the testing of drugs and the preparation of pharmaceutical products.

Definition[edit | edit source]

A Drug Reference Standard, also known as a Pharmaceutical Reference Standard or a Certified Reference Material (CRM), is a defined as a highly purified compound that is well characterized. It is used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments.

Use[edit | edit source]

Drug Reference Standards are used in the pharmaceutical industry to ensure the identity, strength, quality and purity of drug products. They are used in various types of pharmaceutical testing, from the raw material stage through to finished product testing. They are also used in the development of new drugs and in the conduct of clinical trials.

Types of Drug Reference Standards[edit | edit source]

There are several types of Drug Reference Standards, including:

Primary Standards: These are highly pure compounds that are used as the initial reference point in the calibration of equipment or the preparation of standard solutions in analytical chemistry.
Secondary Standards: These are substances whose properties are established through comparison with a primary standard.
Working Standards: These are standards that are used routinely in the laboratory. They are typically a secondary standard that has been prepared for a specific analysis.

Regulation[edit | edit source]

Drug Reference Standards are regulated by various international bodies such as the World Health Organization (WHO), the United States Pharmacopeia (USP), and the European Pharmacopoeia (EP). These organizations ensure that the standards are prepared and distributed in a manner that ensures their quality and traceability.