![]() ![]() Traceability?AL 2016 EDQM, Council of Europe. CRS (no assigned content value)Īssay determination in the monograph: Titration International vocabulary of metrology Basic and general concepts and associated terms(VIM) 3rd editionĮxample: Paracetamol Ph.Eur. Property of a measurement result whereby the result can berelated to a reference through a documented unbroken chain ofcalibrations, each contributing to the measurement uncertainty The use of secondary standards is permitted once theirtraceability to primary standards has been demonstratedand is documented. Whenever compendial reference standards from an officialsource exist, these should preferably be used as primaryreference standards unless fully justified It is the responsibility of the user to justify/document thesuitability of secondary standards. An official primary standard is used whereverpossible for establishment of secondary standards. The secondarystandard is established by comparison with the primary standard towhich it is traceable. The extent of testing is not so great as is requiredfor the establishment of a primary standard. (for information)A secondary standard should exhibit the same property orproperties as the primary standard, relevant for the test(s) for whichit is established. No expiry date is given: see batch validity statement Items of retesting: All properties which might be subject tochange in the life cycle of a CRS, e.g.: ![]() most pharmacopoeia assay standards) the uncertainties of the assigned values are not stated since they are considered to be negligible in relation to the defined limits of the method specific assays for which they are used.Īfter establishment and adoption there is a standardizedtesting procedure in order to assure the fitness for use ofthe reference standards.ĭepending on the use and the known or predicted stability,substances are retested every 12, 24, 36 or 60 months In some cases that are covered by specific legislation (e.g. assay reference standards why no uncertainty? LC assay Valerian dry extract HRS with assigned content for valerenic acid: Reference material characterized by a metrologically validprocedure for one or more specified properties, accompanied bya certificate that provides the value of the specified property, itsassociated uncertainty, and a statement of metrologicaltraceability. Material, sufficiently homogeneous and stable with respect toone or more specified properties1, which has been established tobe fit for its intended use2 in a measurement process.ġ Properties can be quantitative or qualitative2 Uses may include calibration/assessment of a measurement system/procedure, assigning values to other materials and quality control herbal reference substance (HRS): herbal drug preparation or herbal drug intended for use as stated in a monograph or general chapter of the European Pharmacopoeia. chemical reference substance (CRS) & biological reference preparation (BRP): substance or mixture of substances intended for use as stated in a monograph or general chapter of the European Pharmacopoeia. RS: reference standard established under the aegis of and adopted by the European Pharmacopoeia Commission. Reference standards are used to achieve adequate quality controlof substances for pharmaceutical use and pharmaceuticalpreparations. The term Reference standard is used as a general term coveringreference substances, preparations and spectra. Processing, Labelling, Storage and Distribution No further tolerances are to be applied to the limits prescribedto determine whether the article being examined complies with therequirement of the monograph.ĮUROPEAN PHARMACOPOEIALINK BETWEEN TEXTS AND REFERENCE STANDARDS ![]() General NoticesThe limits prescribed in a monograph are based on data obtained innormal analytical practice they take account of normal analyticalerrors, of acceptable variations in manufacture and compounding andof deterioration to an extent considered acceptable. These reference standards are available from the EuropeanDirectorate for the Quality of Medicines & HealthCare(EDQM). The European Pharmacopoeia Commissionestablishes the official reference standards, which arealone authoritative in case of arbitration. All rights reserved.Ĭertain monographs require the use of referencestandards. European Pharmacopoeia Reference StandardsA Lodi, Head of the Laboratory Department, EDQM, Council of EuropeĪL 2016 EDQM, Council of Europe. ![]()
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