Green Chromatographic Method for Determination of Active Pharmaceutical Ingredient, Preservative, and Antioxidant in an Injectable Formulation: Robustness by Design Expert-Reference-Cited by-同舟云学术

Green Chromatographic Method for Determination of Active Pharmaceutical Ingredient, Preservative, and Antioxidant in an Injectable Formulation: Robustness by Design Expert

Published:2022-09-16 Issue:38 Volume:7 Page:34098-34108
ISSN:2470-1343
Container-title:ACS Omega
language:en
Short-container-title:ACS Omega

Author:

Kowtharapu Leela Prasad¹²,Katari Naresh Kumar²³,Sandoval Christian A.¹,Rekulapally Vijay Kumar⁴,Jonnalagadda Sreekantha Babu³^ORCID

Affiliation:

1. Analytical Development Department, Shenzhen DEC Pharmaceutical Co., Ltd, Shenzhen 518057, China

2. Department of Chemistry, GITAM School of Science, Gandhi Institute of Technology and Management, Hyderabad, Telangana 502329, India

3. School of Chemistry & Physics, College of Agriculture, Engineering & Science, Westville Campus, University of KwaZulu-Natal, P Bag X 54001, Durban-4000, South Africa

4. Analytical Research and Development, Hikma Pharmaceuticals USA Inc, Columbus, Ohio 43228, United States

Publisher

American Chemical Society (ACS)

Subject

General Chemical Engineering,General Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acsomega.2c03387

Reference35 articles.

1. The European agency for the evaluation of the medical products. https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-antioxidants-antimicrobial-preservatives-medicinal-products_en.pdf. (Accessed on October 7, 2021).

2. The European agency for the evaluation of the medical products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf. (Accessed on October 7, 2021).

3. USP 43 NF 38 General Chapters: ⟨341⟩ Antimicrobial agents-content; United States Pharmacopeial Convention, Rockville, Maryland, USA, 2020.

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