# \[e-drug\] quality of generic clarithromycin

**URL:** <https://talk.edrugplus.org/t/e-drug-quality-of-generic-clarithromycin/8384>\
**Category:** e-drug\
**Created:** [June 11, 2000, 6:19am UTC](https://talk.edrugplus.org/t/e-drug-quality-of-generic-clarithromycin/8384 "2000-06-11T06:19:30Z")\
**Posts on this page:** 1\
**Page:** 1

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**Author:** ![Peter\_Mansfield](https://avatars.discourse-cdn.com/v4/letter/p/c4cdca/32.png) [@Peter\_Mansfield](https://talk.edrugplus.org/u/Peter_Mansfield)\
**Post date:** [June 11, 2000, 6:19am UTC](https://talk.edrugplus.org/t/e-drug-quality-of-generic-clarithromycin/8384/1 "2000-06-11T06:19:30Z")

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E-drug: quality of generic clarithromycin  
--------------------------------------------  
Dear E-druggers,  
The study below will be used by drug companies for anti-generic drug  
promotion. Are any of you willing to look at the full report and  
comment on whether the quality differences found are large enough to be  
likely to produce clinically important differences when used by  
patients?  
Thankyou.  
regards,  
Peter

Reproduced from Medscape under fair use.  
A Survey of the Quality of Generic Clarithromycin Products from 13  
Countries  
C.H. Nightingale, Institute of International Healthcare Studies,  
Hartford Hospital and University of Connecticut School of Pharmacy,  
Hartford, Connecticut, USA=20  
------------------------------------------------------------------  
Abstract  
Objective: This study evaluated the quality of 40 generic clarithromycin  
products from Latin America and Asia.  
Materials and Methods: The generic products were examined visually,  
assayed by high pressure liquid chromatography for clarithromycin  
content and impurities, tested for dissolution properties, and compared  
with the innovator product manufactured by Abbott Laboratories.  
Results: This survey found that many generic clarithromycin products are  
not equivalent to the innovator product, falling short of the approved,  
registered specifications for the innovator product. Overall, 20% (8 of  
40) of all generic tablets tested, and 33% (6 of 18) of tablets from  
Latin America, failed to contain between 95 and 105% of the  
clarithromycin claimed in the label, thus falling short of the approved  
registered specification for the innovator product. A total of 70% (28  
of 40) of products tested released less drug in 30 minutes than did the  
innovator tablets, although they still met the dissolution specification  
requiring that 80% of the drug must dissolve in 30 minutes; one generic  
product failed to meet the specification. A total of 60% (24 of 40) of  
the generic products tested exceeded the Abbott Laboratories' 3% limit  
for total impurities in bulk drug, and 70% (28 of 40) exceeded the  
Abbott Laboratories' 0.8% limit for 6,11 di-O-methyl erythromycin A.  
Conclusions: These results suggest that generic tablets are not  
equivalent to the innovator product, raising concerns that clinical  
trial results achieved with branded clarithromycin (Abbott Laboratories)  
should not be extrapolated to generic products. [Clin Drug Invest  
19(4):293-305, 2000. A9 2000 Adis International Limited]

Dr Peter Mansfield  
GP  
Director, MaLAM (Medical Lobby for Appropriate Marketing)  
MaLAM aims to protect compassionate scientific medical care from  
marketing practices that may be detrimental to health.  
peter.mansfield@flinders.edu.au  
www.camtech.net.au/malam  
PO Box 172 Daw Pk SA 5041 Australia  
ph/fax +61 8 83742245  
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