Revised USP Chapter <1226> Verification of Compendial Procedures

The revised USP general chapter <1226> VERIFICATION OF COMPENDIAL PROCEDURES has been approved for USP42-NF37, second supplement. The draft chapter was published for comment in Pharmacopeial Forum PF 44(3) [May-June 2018].

The second supplement to USP 42–NF 37 will be released in June 2019 and will become official on December 1, 2019. According to the draft the revised general chapter <1226> will introduce changes under "verification requirements" to indicate that the stability of solutions used for testing needs to be evaluated during the verification of the procedure ("It is the user's responsibility to demonstrate the stability of standard and sample preparations throughout the duration of the procedure").

However, if the verification of the compendial procedure is not successful, it may be concluded that the procedure may not be suitable for use with the article being tested. It may then be necessary to develop and validate an alternative method as allowed in USP´s General Notices, 6.30 Alternative and Harmonized Methods and Procedures. Furthermore, the alternative procedure may be submitted to USP, along with the appropriate data, to support a proposal for inclusion or replacement of the current compendial procedure.

More detailed Information can be found in the USP general chapter <1226> Verification of Compendial Procedures.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.