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23.08.49 BDN 1
การใชการใช REFERENCE STANDARDSREFERENCE STANDARDS
ในการควบคุมคุณภาพยาในการควบคุมคุณภาพยา
นิดาพรรณนิดาพรรณ เรืองฤเรืองฤทธินนททธินนท
สํานักยาและวัตถเุสพติดสํานักยาและวัตถเุสพติด
กรมวิทยาศาสตรการแพทยกรมวิทยาศาสตรการแพทย
23 23 สงิหาคมสงิหาคม 25492549
23.08.49 BDN 2
Definition
• Pharmaceutical Reference StandardsA substance prepared for use as the standard in an assay, identification or purity test, whose relevant properties have been determined and are considered appropriate for its intended use(s).
Pharmaceutical reference standards are required for comparative analytical methods which are included in a manufacturer’s specification or pharmacopoeia monograph.
23.08.49 BDN 3
Test Methods in PharmacopoeiaTest Methods in Pharmacopoeia;;Required Reference SubstancesRequired Reference Substances
Classification of Reference StandardsClassification of Reference Standards
• Primary Reference Standard
• Secondary Reference Standard
(Working Standard)
23.08.49 BDN 5
Classification of Reference StandardsClassification of Reference Standards
•Primary Reference Standard
A designated primary chemical reference substance is
one that is widely acknowledged to have the appropriate qualities within a specified context, and whose value when use as an assay standard is accepted without requiring comparison to another chemical substance.
( WHO working document QAS/05.137)
23.08.49 BDN 6
Classification of Reference StandardsClassification of Reference Standards
• Secondary Reference Standard (Working Standard)
A secondary chemical reference standard is a substance whose characteristics are assigned
and/or calibrated by comparison with a primary
chemical reference substance.
( WHO working document QAS/05.137)
23.08.49 BDN 7
Primary Reference StandardPrimary Reference Standard
• USPRS : United States Pharmacopoeia Reference Standard
• BPCRS : British Pharmacopoeia Chemical Reference
Standard
• EPCRS : European Pharmacopoeia Chemical Reference
Standard
• ICRS : International Chemical Reference Standard
• NIBSC : National Institute of Biological Standard and Control
23.08.49 BDN 8
Secondary Reference StandardSecondary Reference Standard
• ARS : ASEAN Reference Standard
• DMScRS : Department of Medical Sciences
Reference Standard
• Inhouse working standards
23.08.49 BDN 9
Use of Reference StandardUse of Reference Standard
• Identification
• Test for impurities or degradation products
• Assay
23.08.49 BDN 10
Use of Reference StandardUse of Reference Standard
• Reference standards must be used
consistently to ensure reliable
measurements.
• Important to the user is the fact that the
proper use of an reference standards
23.08.49 BDN 11
Use of Reference StandardUse of Reference Standard
• Intended information
– Period of validity
– Conditions for storage
– Instruction for use
– Intended use
23.08.49 BDN 12
Use of Reference StandardUse of Reference Standard
• Sources of information
– Certificate of Analysis
– Catalog book
– Recommendation document
– Label on the vial
23.08.49 BDN 13
Use Reference StandardUse Reference Standard
• ICRS, ARS, DMScRS : Certificate of Analysis
• EPCRS, BPCRS : Catalog Book, Booklet
• USPRS : - Recommendation document
- Label on the Vial
• NIBSC : Catalog Book
23.08.49 BDN 14
Certificate of AnalysisCertificate of Analysis
ICRS, ARS, DMScRS
• Assigned value with test methods employed
• Loss on drying / Water content
• Related substances / Degradation products
• Others : IR, Specific optical rotation
• Direction for use and storage
23.08.49 BDN 15
Certificate of AnalysisCertificate of AnalysisDEXAMETHASONEDEXAMETHASONE
Material or substance one or more of whose properties are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method or for assigning values to materials.
23.08.49 BDN 32
Definition
• Certified reference material: ISO Guide 34Reference material, accompanied by a certificate, one or more of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertaintyat a stated level of confidence.