Elemental impurities determination in bromhexine hydrochloride injections-Reference-Cited by-同舟云学术

Elemental impurities determination in bromhexine hydrochloride injections

Published:2023-05 Issue: Volume:229 Page:115379
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Xu Shujuan,Zhang Lei,Bai Qingshan,Wang Lihua,Chen Xiao

Publisher

Elsevier BV

Subject

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

Reference36 articles.

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3. Challenges to conclude elemental impurities risk assessment for pharmaceutical dosage form and submission in regulatory dossier;Prajapati;J. Generic Med.: Bus. J. Generic Med. Sect.,2017

4. Elemental impurities in pharmaceutical products adding fuel to the fire;Maithani;Regul. Toxicol. Pharmacol.: RTP,2019

5. ICH. Guideline for Elemental Impurities Q3D [EB/OL].（2014–12-16）[2019–02-03]. 〈https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf〉.

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