Folic Acid CAS 59-30-3

What is Folic Acid?

Folic acid is pteroyl-L-glutamic acid, C₁₉H₁₉N₇O₆ — a pterin ring joined through para-aminobenzoic acid to a glutamic acid residue. It is the synthetic, fully oxidised form of vitamin B9, more stable and better absorbed than the natural folates found in food.

It is a yellow to orange-yellow crystalline powder, practically insoluble in water at neutral pH and readily soluble in dilute alkali. That solubility behaviour shapes how it is formulated: aqueous products usually need a slightly alkaline vehicle or a solubilised form, and solid dosage forms need good blending to compensate for the very low dose.

Stability is the defining commercial issue. Folic acid degrades under light, under acid conditions, with heat and in the presence of oxidising agents and some metals, breaking down to pterin fragments and para-aminobenzoylglutamic acid. Light protection in storage and in packaging is not optional.

Its single largest public health application is the prevention of neural tube defects, which has driven mandatory flour fortification programmes in a great many countries. Prenatal supplements, anaemia treatment, general multivitamins and feed premixes make up the rest of the demand.

Why folic acid specifically

• More stable and better absorbed than natural folates. The synthetic fully oxidised form survives processing and storage far better than the reduced folates in food, which is why fortification programmes specify it.
• Established public health role. Its effect on neural tube defect prevention is the basis of mandatory fortification in many countries, which makes the demand both large and regulated.
• Effective at microgram doses. Typical doses are hundreds of micrograms, so the material cost per dose is negligible — the formulation challenge is uniformity, not cost.
• Compendial everywhere. IP, BP, Ph. Eur. and USP monographs all cover it, which makes specification straightforward once the grade is named.

How Folic Acid is Manufactured

Folic acid is made by assembling three fragments in one condensation. The reaction is efficient but leaves a characteristic set of related pterin impurities.

• Fragment preparation. A triaminopyrimidinone, a three-carbon unit such as a trichloroacetone or dihydroxyacetone derivative, and para-aminobenzoyl-L-glutamic acid are prepared or sourced.
• Condensation. The three fragments are condensed in one step, forming the pterin ring and attaching the para-aminobenzoylglutamate side chain.
• Purification. The crude product is dissolved in alkali, treated and reprecipitated by acidification. Related pterin substances are the characteristic impurities and the figures the monographs limit.
• Drying under light protection. Dried under controlled conditions with light excluded, because degradation begins during processing if it is not.
• Milling and particle size control. Milled to the agreed particle size, which matters enormously because the dose is so small that blend uniformity depends on it.

Typical Commercial Specification

Figures below are representative of pharmacopoeial grade. Food fortification and feed grades, and specific particle sizes for premix uniformity, are available — send us the specification or the monograph you work to.

Physical & Chemical Properties

Behaviour in the formulation

Folic acid is one of the less forgiving vitamins, and almost every formulation decision around it is about protecting it:

• Photodegradation. Light cleaves the molecule to pterin and para-aminobenzoylglutamic acid fragments. Amber glass, opaque blisters and light-protected storage are standard practice for a reason.
• Acid instability. It degrades in acidic conditions, which constrains liquid formulation and matters in gastric-exposed products.
• Low aqueous solubility. Practically insoluble at neutral pH, so liquid formulations need an alkaline vehicle or a solubilising approach.
• Low-dose uniformity. At a few hundred micrograms per dose, blend uniformity depends on particle size and on trituration or premix technique rather than on chemistry.
• Interaction with other vitamins. Riboflavin in solution under light accelerates its degradation, and oxidising agents and some metal ions attack it directly — which complicates multivitamin formulation.

Folic Acid vs the Folate Forms and Related Vitamins

Several folate forms reach the market, and the choice is about stability, cost and the regulatory position in your territory.

Stated plainly: folic acid is the stable, inexpensive, well-documented form, which is why every fortification programme in the world uses it. The reduced folates have a formulation and marketing case but cost far more and are harder to keep stable — and in a fortified flour supply, stability over months of storage is the entire requirement.

Industries We Supply Folic Acid To

The same yellow powder goes to a prenatal supplement line, a flour mill and a feed premix plant. What changes between them is the grade, the particle size and the documentation each sector expects.

Where Folic Acid is Used

Folic acid is bought for a small number of well-defined applications, most of them regulated. These are the end uses our customers buy it for.

In prenatal supplements and fortification

The public health case for folic acid is unusually well established, and it drives both the prenatal supplement market and the mandatory flour fortification programmes operating in many countries. In both, the practical challenge is the same: the dose is a few hundred micrograms against a tablet or a tonne of flour, so everything depends on uniform distribution. Fortification premixes exist precisely to solve this, and particle size is specified as carefully as purity.

Formulating around the stability

Folic acid degrades under light, in acid and with heat, and those three constraints shape every formulation it appears in. Solid dose products use opaque packaging; liquid products need a neutral to slightly alkaline vehicle and light protection; and multivitamin formulations have to account for interactions with riboflavin and with oxidising components. Overage is common practice, but it is not a substitute for protecting the material, since the degradation continues through shelf life.

In feed and clinical nutrition

Feed premixes include folic acid as a required nutrient, with the same uniformity challenge and generally looser purity specifications than pharmaceutical use. Clinical nutrition products face the sharpest version of the stability problem, since they are often aqueous, stored for long periods and sometimes exposed to light during administration — which is why light-protective administration sets are used with some parenteral products.

Quality Control & Testing

Every lot is released against a batch-specific Certificate of Analysis written against the monograph you nominate, with the water and particle size figures your potency and uniformity depend on reported alongside.

• Assay — on the anhydrous basis, which is the figure your charge calculation must use alongside the water content.
• Water content — Karl Fischer. Up to 8.5%, and directly relevant to how much you charge per batch.
• Related substances — the pterin impurities that reflect how cleanly the condensation and purification ran.
• Free para-aminobenzoylglutamic acid — both a process impurity and a degradation marker.
• Particle size — reported where a distribution has been agreed, which is critical at these dose levels.
• Residue on ignition and heavy metals — inorganic residue and elemental impurity control.
• Light-protected sampling — samples are drawn and stored protected from light, because unprotected handling degrades the material before it reaches the instrument.

Common Process Problems & Likely Causes

When folic acid causes trouble, it is almost always light, moisture or low-dose uniformity. This table is the shortcut our technical desk works through before anyone opens a complaint file.

Packaging, Storage & Shipping

• Standard packing. 25 kg net in fibre drums with opaque polyethylene liners, palletised and shrink-wrapped.
• Light protection. This is the governing storage rule. Keep the material in its original opaque packing, store in a dark area, and minimise the time drums spend open under plant lighting.
• Storage. Cool, dry and well-ventilated, away from acids, oxidising agents and heavy metal salts.
• Moisture. The material is hydrated, and its water content affects the potency calculation. Keep liners tied so the figure on the certificate remains meaningful.
• Low-dose handling. At microgram doses, use a trituration or premix rather than adding the neat powder to a large blend, and treat the blending step as critical.
• Dust control. Charge under local exhaust ventilation; the fine coloured powder stains and travels.
• Shelf life. Typically 24 to 36 months in unopened original packing under those conditions. Re-test assay, water and related substances rather than assume.
• Transport classification. Not classified as a dangerous good for transport.

Hazards & Safe Handling

Folic acid is a vitamin with a long record of safe use in food, supplements and medicines. It is not classified as hazardous, and the handling considerations are physical rather than toxicological.

• Dust explosion risk. Like any fine organic powder, airborne folic acid presents a dust explosion hazard. Earth and bond transfer equipment and control ignition sources.
• Nuisance dust. Not toxic, but airborne dust irritates the respiratory tract mechanically. Local exhaust ventilation at charging and dispensing points.
• Staining. The yellow powder stains skin, clothing and equipment. Contained transfers and prompt clean-up save considerable effort.
• Eye contact. Mechanical irritation only. Safety glasses during dispensing and transfer.
• PPE. Dust mask where dust is generated, safety glasses and normal plant workwear. No special chemical protection is required.
• Incompatibilities. Oxidising and reducing agents, acids and heavy metal ions — relevant to product stability more than to worker safety.
• Spill response. Sweep or vacuum avoiding dust clouds; expect staining and allow time for cleaning.
• Environment. Not hazardous to the aquatic environment. Dispose as ordinary industrial waste in line with local regulations.

Regulatory & Compliance Notes

Folic acid is a compendial vitamin, a permitted and often mandated fortificant, and an approved feed additive. Because obligations differ by territory and use, the notes below are orientation rather than legal advice — confirm your own position with your regulatory adviser.

• Pharmacopoeial status. Monographs in IP, BP, Ph. Eur. and USP. We supply against the monograph you nominate, with a compliance statement on the COA.
• Mandatory fortification. Many countries mandate folic acid fortification of flour or other staples, with defined addition levels. Fortification-grade material and supporting documentation are quoted for those programmes specifically.
• Upper intake levels. Several territories set upper limits on folic acid in supplements, partly because high intakes can mask vitamin B12 deficiency. Confirm the permitted level for your market and product type.
• Feed additive status. Approved as a nutritional feed additive in the major regulatory systems, with feed-grade documentation available.
• Supporting statements. BSE/TSE, allergen, GMO, halal and kosher statements available; it is a wholly synthetic product with no animal-derived input.
• Excipient and active GMP. Where folic acid is the active rather than a nutrient, the GMP and documentation expectations are those applying to an API. Tell us which position it occupies in your product.

We Supply Folic Acid Worldwide

Chelora Chemicals is a supplier and export partner, not a single-plant trader. We ship Folic Acid from India to customers across Asia, Europe, the Middle East, Africa, and North and South America, handling the export documentation, pharmacopoeial and fortification documentation and freight so the material arrives ready to use.

• Incoterms. EXW, FOB, CIF, CFR and DAP quoted to suit your purchasing terms and freight arrangements.
• Ports. Regular shipments through Nhava Sheva (JNPT) and Mundra, with other Indian ports arranged where it suits the routing.
• Documentation. Commercial invoice, packing list, certificate of origin, COA, SDS and the monograph compliance and supporting statements issued as a complete set.
• Flexible volumes. A single drum for laboratory qualification, through LCL consolidations, up to repeat full container loads on a supply contract.
• Supply continuity. Because we are independent of any one producer, a plant turnaround or a shipping disruption at one source does not have to become your stock-out.

Buying Folic Acid from Chelora

We are an independent sourcing and supply partner. For folic acid that means settling two things at enquiry: the particle size your blend uniformity depends on, because the dose is measured in micrograms, and whether the material is an active, a supplement ingredient or a fortificant — because the documentation differs accordingly.

• Documentation on every lot. Batch-specific COA written against the nominated monograph, with water content and particle size reported, plus SDS, TDS and supporting statements.
• Samples before commitment. Trial quantities, light-protected, for formulation qualification ahead of a commercial order.
• Quantities. From a single 25 kg drum through to full container loads on contract supply.
• Light-protected packing. Opaque liners as standard, with additional protection where your storage conditions require it.
• Export experience. Packing, labelling and export documentation handled for sea and air freight.
• Related vitamins. Niacinamide, vitamin E acetate and the wider vitamin and excipient range from one supplier, which keeps a prenatal or multivitamin formula on a single order.

How ordering works

• Send the enquiry. Product, grade or pharmacopoeia standard, quantity, destination port and the Incoterm you buy on. If you have a spec sheet, attach it — it saves a round trip.
• We quote. Price, lead time, packing and a sample COA, normally within one working day.
• Sample and qualify. For first orders or critical applications, we send a trial quantity so your lab can sign off before you commit.
• Confirm the order. Proforma invoice issued; payment terms agreed against the volume and the relationship.
• Production and QC. Material allocated and released against a batch-specific COA, with a pre-shipment sample where the application calls for it.
• Ship and document. Packed, labelled and loaded with the full export document set, and tracked through to arrival.

Related Vitamins, Nutraceuticals & Excipients

Buyers of folic acid usually source several of these alongside it — prenatal and fortification programmes typically buy three or four together. Consolidating them on one order cuts freight cost and gives you a single point of contact for documentation.