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THE PHARMA REVIEW (SEPTEMBER 2009)

Role of Reference Standard in Analysis of Drugs and Pharmaceuticals

Rakesh Kr. Rishi, Dr. Anjan Pal

Introduction: Any drug analysis comprises a series of operations, usually from sampling via measurements to evaluations leading to the analytical result. Appropriate methods, procedures, and practices have to be designed and applied to ensure that the end result will meet “fitness-for-purpose” requirements. Reference standards were originally introduced for biological assays but with the development and extensive use of newer sophisticated method of analysis like chromatography, spectrophotometry etc. that require measurement relative to a reference standard to attain accurate and reproducible results time to time new reference standards are issued by the issuing body. The application of reference standards in ascertaining quality of drugs and pharmaceuticals is now well established and followed by a wide range of international, national and professional organizations. The purpose of having reference standards is to achieve accuracy and reproducibility of the analytical results required by pharmacopoeial testing and pharmaceutical control in general. Each standard is generally established for a specific analytical purpose, defined by the issuing body. Its use for any other purpose becomes the responsibility of the users and a suitable caution like “ not intended for administration to humans or animals as drugs or medical devices” is included in the accompanying information sheet.

A reference standard or reference material (RM) is a “material or substance one or more of whose property values 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”, whereas a certified reference material (CRM) is a “reference material accompanied by a certificate issued by a certifying body, one or more of whose property values are certified by a technically valid 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 uncertainty at a stated level of confidence.” According to these definitions, CRMs form a subgroup of RMs, namely, that RMs which possesses additional characteristics - a certificate and traceable assigned values with an uncertainty statement.
 
Types of Reference Materials
Certified Reference Material: A reference material or substance one or more of whose property values are certified by a technically valid procedure, accompanied by or documentation which is issued by a certifying body.
Chemical Reference substance: A chemical reference substance is an authenticated, uniform material that is intended for use in specific chemical and physical tests, in which its properties are compared with the properties of a product under examination, and which possesses a degree of purity adequate for its
intended use.
 
Chemical reference substances can sub-divided into two category namely :

 

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