Iron and Folic Acid Tablets

Iron and Folic Acid Tablets

Two-nutrient tablet · elemental iron with folic acid (CAS 59-30-3)

Compressed tablets combining elemental iron from ferrous fumarate, ferrous bisglycinate or carbonyl iron with folic acid. Lactose-free and vegan by default, strengths and coating built to the buyer's brief.

Specifications

Dosage formCompressed tablet, film-coated or sugar-coated; uncoated, bilayer and modified-release routes available. Also offered as a capsule on the same actives.
Iron source - ferrous fumarateCAS 141-01-5, C4H2FeO4, MW 169.9, EINECS 205-447-7. About 32.9% elemental iron by formula. Brown to reddish-brown powder, slightly soluble in water.
Alternative iron sourcesFerrous bisglycinate CAS 20150-34-9, C4H8FeN2O4, MW 203.96, a 1:2 iron-glycine chelate; carbonyl iron CAS 7439-89-6, USP-NF not less than 98.0% Fe.
Folic acidPteroyl-L-glutamic acid, CAS 59-30-3, C19H19N7O6, MW 441.40. Assay 97.0-102.0% USP anhydrous, 96.0-102.0% Ph. Eur./BP. Water 5.0-8.5% by Karl Fischer.
Typical strengthsElemental iron 14, 18, 20, 27, 45, 60 or 100 mg per tablet with folic acid 400 mcg, 500 mcg or 1 mg. Levels capped to destination-market limits.
Reference dosing benchmarkWHO gives 30-60 mg elemental iron with 400 mcg folic acid daily as its reference for supplementation in pregnancy; quoted only to frame strength selection.
Optional co-activesAscorbic acid, the standard companion in iron tablet design; vitamin B12 as cyanocobalamin or methylcobalamin; zinc; copper; vitamin B6; L-5-methyltetrahydrofolate calcium.
Excipients and diet statusLactose-free by default on microcrystalline cellulose and dicalcium phosphate. Magnesium stearate is vegetable-sourced, not tallow-derived, unless the buyer directs otherwise.
Allergen and origin declarationVegan and vegetarian. Free of milk, egg, soy, fish, crustacean, mollusc, cereal gluten, peanut, tree nut, sesame, mustard, celery, lupin and sulphites.
CoatingAqueous HPMC film coat colour-matched to brand and free of shellac and carmine so the vegan line holds. Sugar coat available where the buyer prefers it.
Stability controlIron catalyses folate loss, so the two are granulated separately or the folate is coated. Alu-Alu blister advised for hot and humid destinations.
Finished-product testingIron by AAS or ICP-OES, folic acid by HPLC, plus uniformity of dosage units, hardness, friability, disintegration, dissolution and microbial limits.
Shelf life and storage24 months from manufacture in unopened original pack, stored below 25 C at relative humidity not above 60%, protected from light and moisture.
HS code (India ITC-HS)21069099 as a food supplement. A drug-licensed tablet in measured doses falls to heading 3004, subheading 3004.50. See the classification note.
This is a two-nutrient tablet built around a buyer-selected iron source and folic acid. Ferrous fumarate, CAS 141-01-5, is the workhorse: at C4H2FeO4 and a molecular weight of 169.9 it carries about 32.9 per cent elemental iron by formula, so a 60 mg elemental dose needs roughly 182 mg of salt before any manufacturing overage. Ferrous bisglycinate, CAS 20150-34-9, is the 1:2 iron-glycine chelate specified where taste, low astringency and a reduced metallic note drive the brief; because commercial chelate is hygroscopic and variably hydrated, the elemental iron figure is taken from the supplier's certificate rather than calculated from the formula. Carbonyl iron, CAS 7439-89-6, is elemental iron at not less than 98.0 per cent to USP-NF with the fine spherical particle size that route produces. Folic acid is pteroyl-L-glutamic acid, CAS 59-30-3, C19H19N7O6, molecular weight 441.40, assayed 97.0 to 102.0 per cent on the anhydrous basis to USP and 96.0 to 102.0 per cent to Ph. Eur. and BP. Typical builds run 14 to 100 mg elemental iron against 400 microgram, 500 microgram or 1 mg of folic acid, with the ceiling set by the destination market rather than by formulation limits. WHO's reference figure for supplementation in pregnancy, 30 to 60 mg elemental iron with 400 microgram folic acid daily, is the anchor most tender specifications are written around and is quoted here only to frame strength selection. Iron catalyses folate degradation on storage, so the two actives are granulated separately or the folate is coated, and Alu-Alu blistering is advised for hot, humid destinations. Excipient choice carries the allergen and diet declaration, and this is where iron tablets most often trip a buyer up. Thovek builds lactose-free as standard on microcrystalline cellulose and dicalcium phosphate, keeping milk off the label, and uses vegetable-sourced magnesium stearate rather than tallow-derived so that the vegan claim holds. The aqueous HPMC film coat is free of shellac and carmine for the same reason. Tablets are vegan and vegetarian and free of milk, egg, soy, fish, crustacean, mollusc, cereal gluten, peanut, tree nut, sesame, mustard, celery, lupin and sulphites. Release testing covers iron by AAS or ICP-OES, folic acid by HPLC, uniformity of dosage units, hardness, friability, disintegration, dissolution and microbial limits. Thovek describes composition only; permitted label wording is the buyer's responsibility in the destination market.

Applications

Prenatal supplement rangesWomen's daily multivitamin linesPublic-health tender supplyPharmacy private-label tabletsVegan iron supplement linesContract manufacturing fill programmesAdolescent nutrition programmesInstitutional export packs

Available grades

Iron from ferrous fumarate, ferrous bisglycinate or carbonyl iron; ferrous ascorbate and iron(III) pyrophosphate on request. Folic acid as standard, L-5-methyltetrahydrofolate calcium on request. Uncoated, HPMC film-coated, sugar-coated or bilayer. Lactose-free and vegan standard. Kosher and halal certification available.

Packaging: Alu-Alu or Alu-PVC/PVDC blisters of 10, 15 or 30; HDPE bottles of 30, 60, 90 or 100 with induction seal and desiccant; bulk 5,000 to 50,000 tablets in double polybag inside an HDPE drum. Alu-Alu is advised for hot and humid destinations. Lot coded, palletised and shrink wrapped.

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