alexa Tablet identification using near-infrared spectroscopy (NIRS) for pharmaceutical quality control.
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Bioequivalence & Bioavailability

Author(s): Alvarenga L, Ferreira D, Altekruse D, Menezes JC, Lochmann D

Abstract Share this page

Abstract A need for more reliable and faster analytical methods for the identification of the active pharmaceutical ingredient (API) in finished pharmaceutical products is launched by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, Q6A (1999). The use of infrared spectroscopy is suggested as a means to obtain specific identification. Near-infrared spectroscopy (NIRS) is a reliable method that offers important advantages for the large-scale production of tablets, such as high-throughput and accurate multiparametric data collection. Despite the grown number of reported NIRS identification methods, only a few methods have been approved by the regulatory authorities, which might be due to difficulties on clearly presenting the methods in official documents and audits. Motivated by the lack of clear protocols for the NIRS method's development, here we propose a process for building reliable identification NIRS methods. For illustration purposes, a method is described for the identification of API in coated tablets containing 2\%, 4\% and 8\% of thiamazole. The method described was successfully validated according to the International Conference on Harmonisation (ICH) of Technical Requirement for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology, Q2 (2005). The described method was subsequently approved by European national authorities and thus is suitable for use in cGMP environment. This article was published in J Pharm Biomed Anal and referenced in Journal of Bioequivalence & Bioavailability

Relevant Expert PPTs

Relevant Speaker PPTs

Recommended Conferences

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords