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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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