Development of a sample preparation method for accurate analysis of 24 elemental impurities in oral drug products by ICP-MS according to USP/ICH guidelines-Reference-Cited by-同舟云学术

Development of a sample preparation method for accurate analysis of 24 elemental impurities in oral drug products by ICP-MS according to USP/ICH guidelines

Published:2021 Issue:3 Volume:36 Page:512-517
ISSN:0267-9477
Container-title:Journal of Analytical Atomic Spectrometry
language:en
Short-container-title:J. Anal. At. Spectrom.

Author:

Gu Xiao¹²³⁴⁵^ORCID,Zhu Siqi⁶⁷⁴⁵,Yan Linqi¹²³⁴⁵,Cheng Lei¹²³⁴⁵,Zhu Peixi⁸⁹⁴⁵,Zheng Jinqi¹²³⁴⁵^ORCID

Affiliation:

1. Zhejiang Institute for Food and Drug Control

2. Key Laboratory of Core Technology for Generic Drug Evaluation

3. China Drug Administration

4. Hangzhou

5. China

6. National Anti-Drug Laboratory Zhejiang Regional Center

7. Zhejiang Anti-Drug Technology Center

8. College of Pharmaceutical Sciences

9. Zhejiang University of Technology

Abstract

A novel sample preparation strategy was developed for accurate analysis of all 24 USP/ICH target elements in oral drug products.

Publisher

Royal Society of Chemistry (RSC)

Subject

Spectroscopy,Analytical Chemistry

Link

http://pubs.rsc.org/en/content/articlepdf/2021/JA/D0JA00519C

Reference20 articles.

1. The United States Pharmacopeial Convention , “232” Elemental Impurities-Limits , 2018

2. A rapid ICP-MS screen for heavy metals in pharmaceutical compounds

3. A multi-element ICP-MS survey method as an alternative to the heavy metals limit test for pharmaceutical materials

4. The United States Pharmacopeial Convention , “233” Elemental Impurities—Procedures , 2018

5. The United States Pharmacopeial Convention , “231” Heavy Metals , 2018

Cited by 8 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Greening microwave-assisted digestion method using hydrogen peroxide for determination of elemental impurities by ICP-OES in antihypertensive active pharmaceutical ingredients;Journal of Pharmaceutical and Biomedical Analysis;2024-01

2. Determination of trace elements in ibuprofen drug products using microwave-assisted acid digestion and inductively coupled plasma-mass spectrometry;Heliyon;2024-01

3. Elemental impurities determination in bromhexine hydrochloride injections;Journal of Pharmaceutical and Biomedical Analysis;2023-05

4. Determination of Trace Elements in Ibuprofen Drug Products Using Microwave-Assisted Acid Digestion and Inductively Coupled Plasma-Mass Spectrometry;2023

5. Iridium nanoclusters as high sensitive-tunable elemental labels for immunoassays: Determination of IgE and APOE in aqueous humor by inductively coupled plasma-mass spectrometry;Talanta;2022-07