Thursday, 24 April 2014

New USP Pharmacopeial Forum 40 (1)

Some proposed USP changes in the new edition of the USP Pharmacopeial Forum of interest to laboratory staff are:

Chapter 41     Balances (Interim Revision 1 July 2014)

Comments received indicate the potential existence of a problem with the repeatability requirement. When following the procedure as written in the chapter, the use of a large test weight may produce an unintended passing result. In order to correct this problem, the EC proposes to modify the test using the “desired smallest net weight” value as the divisor. The desired smallest net weight can be selected on the basis of the weighing operations performed in that particular balance.

Chapter 852   Atomic Absorption Spectroscopy [NEW] (Revision proposal target, USP38-NF33)


Accuracy and Precision requirements are revised, and other minor corrections are also incorporated.

Chapter 853   Flourescence Spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Additional changes in the section Accuracy in Validation and Verification. The revision clarifies that the acceptance criteria apply to the mean value obtained.

Chapter 854   Mid-Infrared spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Changes are proposed for this new general test chapter. In Wavenumber Accuracy, additional peaks of the polystyrene spectrum are mentioned. In Procedure, the microscope sampling technique is reinstated. In Accuracy in Validation and Verification, the acceptance criteria has been clarified to apply to the mean value obtained. Other minor corrections are also incorporated.

Chapter 857   Ultraviolet-Visible Spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Several changes are proposed in this new general chapter. Under Qualification of UV–Vis Spectrophotometers, the acceptance criteria for Control of Wavelengths are revised. Clarifications are introduced in the Limit of Stray Light test. Accuracy requirements are revised to indicate that the acceptance criteria apply to the mean value obtained. Other minor corrections are also incorporated.

Chapter 1852 Atomic Absorption Spectroscopy – Theory and Practice [NEW] (Revision proposal target, USP38-NF33)

Additional changes are proposed for this new general information chapter.

Chapter 1853 Flourescence Spectroscopy – Theory and practice [NEW] (Revision proposal target, USP37-NF32)

Additional changes are proposed for this new general information chapter.

Chapter 1854 Mid-Infrared Spectroscopy – Theory and Practice [NEW] (Revision proposal target, USP38-NF33)

Additional changes are proposed for this new general information chapter

Posted by Tim Sandle

Special offers