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)
Posted by Tim Sandle
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