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Coming soon: New quality regulations worldwide for botanical materials

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Dilip Charegaonkar, Managing Director, Anchrom Enterprises (I) talks about the effectiveness of HPTLC to know about the chemical fingerprint of a botanical material extract

Dilip Charegaonkar

Pharmacopoeias  of the US, Europe, the UK and others have decided to add ‘HPTLC fingerprint’ as a mandatory test for ‘identification of materials of botanical origin’ and for ‘fixed’ oils (i.e. vegetable oils).

An established chemical analysis method, High Performance Thin Layer Chromatography (HPTLC) , gives an idea about the chemical fingerprint of an extract of a botanical material, without identifying the chemicals present. HPTLC ‘fingerprints’ are unique too and not only establish the identity but also ensure the presence or absence of adulterants, substitutes, similars etc. Since materials of botanical origin are extremely complex, the HPTLC identification test is designed, both to ensure the identity of product by multiple ways of evaluation and the absence of adulterants, substitutes etc.  HPTLC was chosen as the method of choice because it is extremely simple to perform, yet gives a lot of information about the sample at a low cost. A proper fingerprint can also be used for quantification of ‘chemical marker’ substance(s) which is usually done to determine commercial value, in the Western world, markers cannot be used for identification. Sophisticated instrumentation is required for HPTLC analysis, which meets the regulatory and good laboratory practices (GLP) requirements.

20150831ep35‘Botanical origin’ obviously refers to herbal medicines, spices, essential oils, and numerous foods such as vegetable oils, dried fruits, saffron, tea, coffee, natural colours etc. This makes it a very relevant test, especially for our exports worldwide.

India should prepare itself to meet this new requirement by creating HPTLC fingerprints. After August 1, a foreign buyer can ask for a fingerprint of e.g. basmati rice to distinguish it from long grained rice. We need to aggressively safeguard our interests in the worldwide markets, especially for our traditional exports by studying these regulatory changes and creating suitable HPTLC fingerprints proactively.

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