Physics, chemistry, and Hirshfeld surface analyses of gamma-irradiated thalidomide to evaluate behavior under sterilization doses

Author:

Mussel Valner A.F.S.N.,Ferreira Max P.,Marques Maria B.F.,Yoshida Maria I.,Almeida Mariana R.,Rodrigues Bernardo L.,Mussel Wagner N.

Funder

FAPEMIG

CNPq

CAPES

Pró-Reitoria de Pesquisa/UFMG

Publisher

Elsevier BV

Subject

Analytical Chemistry,Electrochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Pharmacy

Reference19 articles.

1. Health Products and Food Branch Inspectorate: Process Validation: Terminal Sterilization Processes for Pharmaceutical Products, Supersedes: GUI-0007, GUI-0009 and GUI-0010, (GUIDE-0074), OTTAWA, Ontario, Canada, 2006.

2. EN ISO 13408-1:2008(en), Aseptic processing of health care products—Part 1: General requirements, compilation prepared by Online Browsing Platform (OBP), 2008, 〈https://www.iso.org/obp/ui/#iso:std:iso:13408:-1:ed-2:v1:en〉.

3. AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (revision of 11137-2: 2012), ISBN(s): 1570205027, 2013.

4. J. Agalloco, USP Microbiology & Sterility Assurance, Expert Committee USP: Activities Impacting Sterilization & Sterility Assurance, USP 35 1211, revision 2008.

5. Gamma sterilization of pharmaceuticals - a review of the irradiation of excipients, active pharmaceutical ingredients and final drug product formulations;Hasanain;J. Pharm. Sci. Technol.,2014

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