Examples of using Compendia in English and their translations into Malay
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Officially recognized compendia methods need not be summarized unless modifications have been made.
Copies of analytical procedures from officially recognized compendia monographs do not need to be submitted.
The compendia methods as published are typically validated based on an API or an FPP originating from a specific manufacturer.
Unless modified it is not necessary to provide copies of officially recognized compendia analytical procedures.
If the officially recognized compendia methods have been modified or replaced, a discussion should be included.
As recognized by regulatory authorities and pharmacopoeias themselves, verification of compendia methods can be necessary.
When choosing excipients those with a compendia monograph are generally preferred and may be required in certain jurisdictions.
Unless modified it is not necessaryto provide copies of analytical procedures described in officially recognized compendia.
If the officially recognized compendia methods have been modified or replaced a discussion of the modifications or replacement method(s) should be included.
A discussion of the tests that are supplementary to those appearing in the officially recognized compendia monograph should be provided.
If an officially recognized compendia standard is claimed and an in-house method is used in lieu of the compendia method(e.g. for assay or for specified impurities), equivalence of the inhouse and compendia methods should be demonstrated.
Strong assurance is provided that samples taken at random will meet regulatoryrequirements if the confidence limits are well within compendia specifications.
Information on polymorphism can come from the scientific literature,patents, compendia or other references to determine if polymorphism is a concern, e.g.
A discussion should be provided on the omission or inclusion of certain tests, evolution of tests, analytical procedures and acceptance criteria,and differences from the officially recognized compendia standard(s).
The standard declared by theapplicant could be an officially recognized compendia standard(e.g. BP, JP, Ph. Eur. Ph. Int., USP) or an in-house(manufacturer's) standard.
List of all components of the dosage form, and their amount on a per unit basis(including overages, if any), the function of the components,and a reference to their quality standards(e.g. compendia monographs or manufacturer's specifications).
If the standard claimed for an excipient is a non-compendia standard(e.g. in-house standard) or includes tests that are supplementary to those appearing in the officially recognized compendia monograph, a copy of the specification for the excipient should be provided.
Compendium of Materia Medica" records"wolfberry fruit smooth and moist, sex nourishing….
Mandarin Dictionary Compendium Yibenhua 2009.
Especially one… I know what"compendium means, Kevin.
It is listed in the book of shennong materia medica, compendium of materia medica.
The Compendium of Environment Statistics(CES) presents statistics on environment for the period 2012-2016/2017 namely air, water(inland and marine), land and urban/human settlements.
According to the Compendium of Materia Medica, a book on Chinese herbal medicine, eating goat and vinegar when concurrent will harm the heart.
The outline of Compendium of Materia Medica includes black wolfberry to treat 33 sides to strengthen the body.
Compendium of Materia Medica" contains black wolfberry to cure 33 prescriptions for strengthening the body.
Compendium": Where the use of wolfberry, pick out branches, take clear-cut washing, liquor moistened overnight, mashed into medicine.
The Compendium ref contains a literature review of general adaptation strategies, management options within those strategy categories, and example design considerations for crafting climate-smart actions.
Group number 12"stationery paper Accessories" Boxes, pouches,wallets and writing compendiums, of paper or paperboard, containing an assortment of paper stationery.
In The 22 Immutable Laws of Marketing,Ries and Trout offer a compendium of twenty-two innovative rules for understanding and succeeding in the international marketplace.