Prenatal Multivitamin Tablets

A prenatal multivitamin is a multi-micronutrient tablet built to a maternal specification rather than a general adult one, and the composition differs from a standard multivitamin mainly in the weighting given to folate, iron and iodine. Thovek formulates to the buyer's brief, with folate supplied either as folic acid (CAS 59-30-3, C19H19N7O6, 441.40 g/mol) at 400–800 µg or as the calcium salt of L-5-methyltetrahydrofolate; elemental iron at 27–60 mg from ferrous fumarate (CAS 141-01-5, C4H2FeO4, 32.87 % elemental iron), ferrous bisglycinate or carbonyl iron; and iodine at 150–220 µg from potassium iodide (CAS 7681-11-0, KI). Around these sit vitamin D3 at 400–600 IU, vitamin B12 at 2.6–5 µg as cyanocobalamin or methylcobalamin, calcium, zinc, magnesium, the remaining B-complex, vitamin C and vitamin E. Where DHA is part of the brief it is supplied as an algal or fish-oil softgel alongside the tablet, since an oil cannot be compressed into the same unit. The formulation work in this category is mostly about keeping reactive actives apart. Iron salts are hygroscopic and interact with ascorbic acid, folic acid and B12, so ferrous fumarate is granulated or taken in as a coated grade to limit contact and to stop the reddish-brown colour migrating through the tablet; overages are then set per active from stability data rather than applied uniformly. Tablets are almost always HPMC film-coated — the coat masks the metallic note of iron, carries the pigment that hides colour variation, and gives moisture-sensitive folate and B12 a barrier. Typical tablet weight runs 800–1,300 mg depending on the mineral load. Compositions are written to the RDA schedule and permitted-additive list of the destination market, whether that is the FSSAI nutraceutical schedule for India, Directive 2002/46/EC annexes for the EU, or a buyer's own specification sheet. Release testing covers assay of each declared active (HPLC for the vitamins, ICP for the minerals), disintegration, friability, uniformity of weight and content, heavy metals and microbiological limits. Each shipment carries the batch certificate of analysis, MSDS, allergen, gluten and GMO statements, a vegetarian or non-gelatin declaration where the coating system allows it, halal and kosher certificates on request, GMP/ISO 22000/HACCP certificates, stability data and FSSAI export documentation, with a Certificate of Free Sale arranged where the importing authority asks for one. The finished tablet classifies under ITC-HS 2106 90 99 as a food supplement; a version registered and licensed as a medicinal product in the destination market may instead fall to heading 3004. No therapeutic representation is made — the product is offered as a micronutrient supplement and the buyer is responsible for label claims permitted in their market.