| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 1223640 | Journal of Pharmaceutical and Biomedical Analysis | 2009 | 6 Pages |
Abstract
An UV-HPLC method for the determination of the potency of mPEG-SC, 5 kDa (1) has been developed and validated. Validation acceptance criteria that is typical of small molecule method validation was successfully applied for this method. The method relies on the HPLC separation of mPEG-OH, 5 kDa (2) and a derivatized form of mPEG-SC, 5 kDa (1). 1-Naphthylmethylamine reacts with mPEG-SC, 5 kDa (1) to form a stable, strongly UV absorbing carbamate 3. When the eluent is analyzed by UV detection at 220 nm, the method was shown to be linear, precise and accurate. The limit of detection of the method was 0.1 μg.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Susan D. Van Arnum, Henry J. Niemczyk, Chinfong Chang,