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|English to English translations [PRO]|
Medical - Medical (general) / API Expiry and Retest dating
|English term or phrase: compendial or customer requirements|
|I've already posted this question on the English to Italian section of Kudoz. Please help me with this translation: |
The Certificate should list each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained (if test results are numerical).
Another sentence (Reserve/ Retention samples of APIs)
Sufficient quantities (of samples od APIs) should be retained to conduct at leaset two full compendial analyses or, when there is no pharmacopeial monograph, two full specification analyses.
In the Italian section two possible translations have been proposed: summary and normative.
Thanks a lot
Selected response from:
Hassan Al-Haifi (wordforword)
Local time: 18:34
|2 KudoZ points were awarded for this answer |
2 hrs confidence:
OEd gives Compendious, brief; expeditious as adjective meaning of compendiary, which I believe is an alternative to compendial
Local time: 17:34
Native speaker of: English
PRO pts in category: 32
|Login to enter a peer comment (or grade)|17 hrs confidence: 18 hrs confidence: 20 hrs confidence: peer agreement (net): +1
USP (United States Pharmacopoeia) requirements or specific customer requirements
"Compendial" refers to the compendium, which in this case is the USP.
in accordance with compendial requirements = in accordance with the USP (United States Pharmacopoeia) requirements
customer requirements = requirements specified by the customer
United States Pharmacopoeia (USP) Official compendium recognized by the Federal Food, Drug, and cosmetic Act. Serves as the basis for enforcement actions by the U.S. Food and Drug Administration involving official (USP) drugs. Published every five years by the United States Pharmacopoeia Convention, a non-profit organization. It is combined with the National Formulary. The USP is the official pharmacopoeia of the United States and several other countries. http://www.labcompliance.com/glossary/u-z-glossary.htm
The United States Pharmacopeial Convention, Inc. (USPC) is an independent organization that sets the standards for determining the quality of pharmaceutical products marketed in the United States of America. The USPC is responsible for publishing the United States Pharmacopeia (USP), a legally recognized compendium used by the pharmaceutical industry. Established in 1820 as a collection of recipes for pharmacists, the USP has evolved into a collection of test methodologies and associated specifications used primarily by proprietary and generic pharmaceutical manufacturers. These standards govern the quality, strength, purity, and potency of excipients, active pharmaceutical ingredients (APIs), pharmaceutical
dosage forms, and many of the reagents, solutions, and indicators used to test these materials. Because of the extensive industry applicability of USP methods, any pharmaceutical testing laboratory must be capable of using the technologies and performing the procedures described in this world-recognized compendium. http://www.pharmtech.com/pharmtech/article/articleDetail.jsp...
| Elizabeth Rudin|
Local time: 16:34
Specializes in field
Native speaker of: Hungarian, Romanian
PRO pts in category: 60
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