Measurement Uncertainty Estimation for the Quantitative Determination of Elemental Impurities in Active Pharmaceutical Ingredients Using Microwave Digestion Followed by ICP-OES According to USP <232> and <233> Specifications-Reference-Cited by-同舟云学术

Measurement Uncertainty Estimation for the Quantitative Determination of Elemental Impurities in Active Pharmaceutical Ingredients Using Microwave Digestion Followed by ICP-OES According to USP <232> and <233> Specifications

Published:2022-02-14 Issue:2 Volume:37 Page:269-283
ISSN:0970-3950
Container-title:MAPAN
language:en
Short-container-title:MAPAN

Author:

Satyanarayana G. N. V.,Bala Subrahanyam Seetha,Silpa N. Yamini Sai,Rao T. Nageswara,Sharma Manisha T.,Mudiam Mohana Krishna Reddy

Funder

Department of Science and Technology, Ministry of Science and Technology

Publisher

Springer Science and Business Media LLC

Subject

Physics and Astronomy (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s12647-022-00537-6.pdf

Reference35 articles.

1. U.F. Guideline, Elemental impurities in drug products guidance for industry, pharmaceutical quality/CMC, (2018).

2. U. Chapter, <233> Elemental impurities limits, United state Pharmacopeia, the national formulary, USP-38-NF33, US Pharmacopeial Forum, (2015).

3. U. Chapter, <232> Elemental impurities limits, United state Pharmacopeia, the national formulary, USP-40-NF35, US Pharmacopeial Forum, (2017).

4. Q.D.R. ICH Guideline for elemental impurities, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, (2019).

5. K. Janchevska, T. Stafilov, S. Memed-Sejfulah, M. Bogdanoska, S. Ugarkovic and G. Petrushevski, ICH Q3D based elemental impurities study in liquid pharmaceutical dosage form with high daily intake–comparative analysis by ICP-OES and ICP-MS. Drug Dev Ind Pharm., 46 (2020) 456–461.

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