Journal article
Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia.
- Arnet I Pharmaceutical Care Research Group, Department of Pharmaceutical Sciences, University of Basel , Basel, Switzerland.
- Altermatt M
- Roggo Y
- Schnetzler G
- 2014-08-22
Published in:
- Journal of chemotherapy (Florence, Italy). - 2015
Ceftriaxone
Eastern Asia
Generics
Pharmaceutical quality
Rocephin
Administration, Intravenous
Anti-Bacterial Agents
Ceftriaxone
Chemistry, Pharmaceutical
China
Drug Contamination
Drugs, Generic
Humans
India
Indonesia
Injections, Intramuscular
Quality Control
English
OBJECTIVES
To compare the pharmaceutical quality of original and generic ceftriaxone sodium preparations for injection produced in Eastern Asia.
METHODS
Standard physical and chemical laboratory tests were performed. Participants/material: Ceftriaxone (Rocephin®, Roche, Switzerland) was the reference material. Generics produced in China, India, and Indonesia were sampled in China and Myanmar within their expiration dates.
RESULTS
Eight generics obtained from Eastern Asia markets in January 2013 were analysed. All eight generics failed the specifications in three or more tests. Residues of solvents and metals were detected in all generics, four were not particle free, and two were not sterile.
CONCLUSIONS
All tested generic ceftriaxone products failed to meet the pharmaceutical quality standards of the branded original. The high levels of impurities and the identified contamination of particles and residues are of clinical concern, as they could impact tolerability and safety in patients in need of an effective parenteral antibiotic.
To compare the pharmaceutical quality of original and generic ceftriaxone sodium preparations for injection produced in Eastern Asia.
METHODS
Standard physical and chemical laboratory tests were performed. Participants/material: Ceftriaxone (Rocephin®, Roche, Switzerland) was the reference material. Generics produced in China, India, and Indonesia were sampled in China and Myanmar within their expiration dates.
RESULTS
Eight generics obtained from Eastern Asia markets in January 2013 were analysed. All eight generics failed the specifications in three or more tests. Residues of solvents and metals were detected in all generics, four were not particle free, and two were not sterile.
CONCLUSIONS
All tested generic ceftriaxone products failed to meet the pharmaceutical quality standards of the branded original. The high levels of impurities and the identified contamination of particles and residues are of clinical concern, as they could impact tolerability and safety in patients in need of an effective parenteral antibiotic.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1179/1973947814Y.0000000208
- PMID 25144924
- Persistent URL
- https://sonar.ch/global/documents/150072
Statistics
Document views: 16
File downloads: