Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP 〈232〉/〈233〉-Reference-Cited by-同舟云学术

Development and validation of an ICP-MS method for the determination of elemental impurities in TP-6076 active pharmaceutical ingredient (API) according to USP 〈232〉/〈233〉

Published:2017-10 Issue: Volume:145 Page:84-90
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Chahrour Osama,Malone John,Collins Mark,Salmon Vrushali,Greenan Catherine,Bombardier Amy,Ma Zhongze,Dunwoody Nick

Funder

Tetraphase Pharmaceuticals

Publisher

Elsevier BV

Subject

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

Reference20 articles.

1. Trace metals sebate;Thayer,2013

2. Chapter 8–Validation of procedures for elemental impurities;Cecil,2014

3. Flow injection combined with ICP-MS for accurate high throughput analysis of elemental impurities in pharmaceutical products according to USP;Fischer;J. Pharm. Biomed. Anal.,2014

4. 〈233〉 Elemental Impurities—Procedures, in: Second Suppl. to United States Pharmacop. Natl. Formul. (USP 38-NF 33), United States Pharmacopeia Convention, 2012: pp. 243–244.

5. 〈232〉 Elemental Impurities—limits, in: United States Pharmacop. Natl. Formul. (USP 38-NF 33), United States Pharmacopeia Convention, 2012: pp. 245–248.

Cited by 35 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. Impurities in Active Pharmaceutical Ingredients and Drug Products: A Critical Review;Critical Reviews in Analytical Chemistry;2024-07-26

2. Catalysis-Based Fluorometric Method for Semiquantifying Trace Palladium in Sulfur-Containing Compounds and Ibuprofen;The Journal of Organic Chemistry;2024-05-28

3. A new ultrasound-assisted microextraction for elemental impurities determination in tablets by ICP-MS according to USP chapters 232 and 233;Talanta;2024-05

4. Analytical validation of a microwave-assisted ICP-MS method for the quantification of elemental impurities in doxycycline hyclate tablets;Chemical Papers;2024-03-18

5. Specificity of the Icp–Ms Method in Ich Q2 (R2) and Method Development for the Detection of 24 Elemental Impurities in a Complex, High Matrix Mineral, Medicinal Lanthanum Carbonate;2024