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 microg.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jpba.2009.04.005 | DOI Listing |
Publication Analysis
Top Keywords
mpeg-sc kda
12
method validation
8
method
6
hplc method
4
validation studies
4
studies specific
4
specific assay
4
assay monomethoxypolyethylene
4
monomethoxypolyethylene glycol
4
glycol succinimido
4
Similar Publications
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!