A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach-Reference-Cited by-同舟云学术

A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach

Published:2020 Issue:3 Volume:12 Page:304-316
ISSN:1759-9660
Container-title:Analytical Methods
language:en
Short-container-title:Anal. Methods

Author:

Kumar K. Y. Kiran¹²³⁴⁵^ORCID,Dama Venugopala Rao¹²³⁴⁵,Suchitra Ch.¹²³⁴⁵,Maringanti Thirumala Chary⁶⁴⁷^ORCID

Affiliation:

1. Analytical Research and Development

2. IPDO

3. Dr Reddy's Laboratories

4. Hyderabad

5. India – 500090

6. Jawaharlal Nehru Technological University

7. India – 500085

Abstract

Among all chemical sameness characterization tests of Therapeutic Peptides (TPs), one of the most significant and challenging aspects is to demonstrate comparable impurity profiles (both qualitative & quantitative) between a generic product and reference listed drug (RLD).

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2020/AY/C9AY01998G

Reference31 articles.

1. 2018 Transparency Market Research Report on Peptides: Peptide Therapeutics Market, Transparency Market Research, 2016–2024

2. FDA Website Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations , http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm , 2019

3. Peptide therapeutics: current status and future directions

4. Future directions for peptide therapeutics development

5. Orthogonality of Separation in Two-Dimensional Liquid Chromatography

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