LC-MS multi-attribute method for characterization of biologics
نویسندگان
چکیده
منابع مشابه
LC-MS multi-attribute method for characterization of biologics
(mAbs), are complex protein molecules produced from mammalian tissue culture cells through recombinant DNA technology. As a result of naturally-occurring molecular heterogeneity as well as chemical and enzymatic modifications during manufacture, process, and storage, there are many product quality attributes (PQAs) presenting in therapeutic proteins. These PQAs can potentially include: product-...
متن کاملLC, MSn and LC–MS/MS studies for the characterization of degradation products of amlodipine
In the present study, comprehensive stress testing of amlodipine (AM) was carried out according to International Conference on Harmonization (ICH) Q1A(R2) guideline. AM was subjected to acidic, neutral and alkaline hydrolysis, oxidation, photolysis and thermal stress conditions. The drug showed instability in acidic and alkaline conditions, while it remained stable to neutral, oxidative, light ...
متن کاملLC-MS/MS Method for Serum Creatinine: Comparison with Enzymatic Method and Jaffe Method
Accurate quantification of creatinine (Cre) is important to estimate glomerular filtration rate (GFR). Differences among various methods of Cre quantification were previously noted. This study aims to develop a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for serum Cre and compare this method with clinical routine methods. LC-MS/MS analysis was performed on API 4000 triple q...
متن کاملA statistical method for chromatographic alignment of LC-MS data.
Integrated liquid-chromatography mass-spectrometry (LC-MS) is becoming a widely used approach for quantifying the protein composition of complex samples. The output of the LC-MS system measures the intensity of a peptide with a specific mass-charge ratio and retention time. In the last few years, this technology has been used to compare complex biological samples across multiple conditions. One...
متن کاملA stability-indicating LC–MS/MS method for zidovudine: Identification, characterization and toxicity prediction of two major acid degradation products
Zidvovudine (AZT) is a nucleoside analogue reverse transcriptase inhibitor (NRTI), a class of anti-retroviral drug. A stability-indicating assay method for AZT was developed in line with ICH guideline. Successful separation of AZT and its degradation products was achieved by gradient elution mode on reverse phase C18 column using 10 mM ammonium acetate: acetonitrile as the mobile phase at 0.8 m...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Journal of Applied Bioanalysis
سال: 2017
ISSN: 2405-710X
DOI: 10.17145/jab.17.003