Identification and characterization of forced degradation products of pralatrexate injection by LC-PDA and LC–MS-Reference-Cited by-同舟云学术

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Identification and characterization of forced degradation products of pralatrexate injection by LC-PDA and LC–MS

Published:2016-11 Issue: Volume:131 Page:400-409
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Sastry R.V.R. Prabhakara,Venkatesan C.S.,Sastry B.S.,Mahesh K.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference12 articles.

1. Australian Public Assessment Report for Pralatrexate, August 2013, https://www.tga.gov.au/auspar/auspar-pralatrexa.

2. Safety and efficacy of pralatrexate in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma;Marchi;Ther. Adv. Hematol.,2012

3. Stability testing of new drug substances and products (step4);ICH Q1A(R2),2003

4. Impurities in new drug substances (step4);ICH Q3A(R2),2006

5. Impurities in new drug products (step4);ICH Q3A(R2),2006

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