[e-drug] Reference Standards

["Irfan Michael and Debbie Roy" <imderoy@super.net.pk>]

E-drug: Reference Standards
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Dear Colleagues
Pharmaceutical preparations which are made and tested according to BP and
USP Pharmacopoeia require USP or BP reference standards for their testing.
Most multinationals provide their sister concerns AWS (Analytical working
standards ) from their parent companies which are generally tested against
USP/BP reference standards or their equivalent. Unfortunately for many
national companies (as far as I know) the USP and BP reference standards are
too costly and are not used and they generally rely on the manufacturer of
the raw material to provide them 'Standards' the traceabilty of which to
official reference standards is often not available.
Are there any institutions /organisations which are providing official
reference standards to pharmaceutical concerns in developing countries at a
cost considerably less than the USP or BP reference standards.
Can a preparation still comply with BP or USP Pharmacopoeia even if the
Analytical standard against which it is tested is of uncertain traceability.

Dr Irfan Michael Roy
A National Pharmaceutical Company
Karachi
"Irfan Michael and Debbie Roy" <imderoy@super.net.pk>
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