Ultra-high Speed Analysis of USP methods conforming to the New USP General Chapter 621 Allowed Limits

The United States Pharmacopeia (USP) defines allowed adjustments of HPLC and GC parameters in the general chapter 621 <chromatography>&gh;. If the system suitability is met, method parameters can be changed within the allowed limits without revalidation. The general chapter 621 was revised in the first supplement to USP37-NF32 published on February 1st 2014 and became official on August 1st 2014. The feature of the new general chapter 621 is that a column packed with small particles can be used if column length and particle ratio (L/dp) is kept constant between the designated and modified column. This enables high speed analysis of USP methods more than ever.

Key parameters of allowed HPLC adjustments in the current and new general chapter 621 were shown in Table 1 and 2, respectively. The allowed adjustments for column length and particle size have been changed in the new general chapter 621. This adjustment can be applied only for isocratic analysis.

Content Type:
Paper
Document Number:
PO-CON1501E
Product Type:
Liquid Chromatography
Keywords:
United States Pharmacopeia USP General chapter 621, USP37-NF32, HPLC, Water Purification System, Pharmaceutical, Life Science, Manufacturing, QA/QC, Prominence, Nexera X2
Language:
English
File Name:
sil215012.pdf
File Size:
139kb

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