top of page

Pharmaceutical Reference Standard – Guidance Update - SFDA

Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished products. They are highly characterized specimens of drug substances, excipients, impurities and degradation products that are used to conduct tests such as:

- Identity

- Purity

- Potency

They are used in many chromatographic and spectrophotometric procedures.

The objective of the policy is to provide information that is required when using the reference standard material during test analysis. This policy will provide sponsors with the SFDA expectations for the use of reference standard material for the analysis of the drug substance (API) and the dosage form.

The scope of this policy includes all New Drugs, Generic Drugs, Veterinary Drugs applications and their supplement and variation. The SFDA expects that the principles established in this policy should be applied in all test analyses of drug products manufactured and marketed in the Kingdom of Saudi Arabia.

Policy of Statement

The SFDA expects that:

  1. The source of the reference standard used in the testing of the drug substance and dosage forms should be properly specified.

  2. The official pharmacopoeial reference standard should be used.

  3. In case the official pharmacopoeial reference standard is not available, a house reference standard is acceptable, providing complete information on the manufacturing and purification process is submitted.

  4. A secondary reference standard can also be used by providing a copy of the certificate of analysis and validating it against a suitable official pharmacopoeial reference standard.

Check out this guideline LINK for detailed information.


bottom of page