Quality control of active pharmaceutical ingredients of plant origin inline by specific optical rotation





inulin, specific optical rotation, quality control


Inulin is a reserve polysaccharide that is common in nature, it is accumulated in the underground organs of many plants, and its largest amount is observed in the family of Asteraceae. Depending on the source of obtaining and manufacturing process conditions, they produce inulin of excellent physical and chemical properties, and this inulin finds its application in food industry, cosmetics, including the pharmaceutical industry. One of the quality indicators for the active pharmaceutical ingredient (API) of plant origin inulin is considered to be its compliance with “Specific optical rotation” test requirements, which allows not only to identify and characterize the purity of optically active medicinal substance, but also to determine the finished product functional characteristics and the possibility of its industrial production.

Aim. To carry out quality control of nine inulin substances of plant origin obtained from chicory, Jerusalem artichoke, agave (batches 01-09) and two standard samples – inulin from chicory (batch 10) and dahlias (batch 11) by specific optical rotation (SOR) in accordance with the requirements of existing regulatory documents – Food Chemicals Codex 7 (FCC), monographs “Inulin” of the British Pharmacopoeia 2010 (BP) and US Pharmacopoeia 36 (USP).

Results. The optimal time for determining the rotation angle of API of inulin, which is 30 minutes after its preparation, has been found. By SOR calculated for the samples of the inulin substances analyzed it has been confirmed that batches 02, 03, 10, 11 and 02, 03, 08, 10, 11 meet the requirements of the monographs “Inulin” of the BP and USP; they can be recommended for manufacture of drugs with inulin. The rest of the batches (01, 05-09) satisfy the requirements of the FCC and can be used as a dietary fiber when manufacturing dietary supplements (DS) with inulin, as well as a filler, a structure former and a binder.

Conclusions. The results of the study obtained can be used when developing national regulatory documents for API of inulin of plant origin. They also can be the basis for quality risk management at the stage of pharmaceutical development of a drug.


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Quality, standardization and certification in pharmacy