Active Pharmaceutical Ingredient

Folic Acid

CAS 59-30-3 · C₁₉H₁₉N₇O₆ · MW 441.40

The essential Vitamin B9 for prenatal health, multivitamin formulations and mandatory food fortification programmes. Chelora supplies pharmacopoeia-grade folic acid — IP, BP and USP — in light-protective packaging with certificate of analysis and complete documentation on every batch.

  • IP / BP / USP grades
  • Non-hazardous transport
  • Light-protective packing
Folic acid sample quality inspection
Microscopic analysis of folic acid crystals

Vitamin B9

essential nutrient

CAS number

59-30-3

Assay (dried)

96 – 102 %

Pharmacopoeia

IP · BP · USP

Transport

Non-DG

Product overview

From pteridine chemistry to public health

Folic acid (pteroylglutamic acid) is the synthetic, fully oxidised form of Vitamin B9 — a water-soluble B-group vitamin essential for one-carbon metabolism, DNA synthesis and repair, amino acid interconversion and red blood cell formation. It was first isolated from spinach leaves in 1941 and takes its name from the Latin folium (leaf).

In the body, folic acid is reduced by dihydrofolate reductase to tetrahydrofolate, the metabolically active coenzyme form. This coenzyme transfers one-carbon units required for purine and thymidylate biosynthesis — processes critical to rapidly dividing cells, which is why folate adequacy is vital during pregnancy, infancy and periods of growth.

The clearest public-health impact of folic acid supplementation is the prevention of neural tube defects (NTDs) such as spina bifida and anencephaly. Periconceptional supplementation with 400 – 800 µg daily has been shown to reduce NTD risk by up to 70 %, and over 80 countries now mandate folic acid fortification of wheat flour or other staple foods.

Folic acid is also used therapeutically to treat megaloblastic anaemia caused by folate deficiency, as an adjunct in methotrexate chemotherapy (leucovorin rescue), and in animal nutrition to support embryo viability and hatchability in breeding programmes. Its yellow to orange-yellow colour, light sensitivity and very limited water solubility are key considerations in formulation and packaging.

Technical specifications

IUPAC nameN-(4-{[(2-Amino-4-hydroxypteridin-6-yl)methyl]amino}benzoyl)-L-glutamic acid
SynonymsPteroylglutamic acid, Vitamin B9, Folacin, Vitamin Bc
CAS number59-30-3
Molecular formulaC₁₉H₁₉N₇O₆
Molecular weight441.40 g/mol
AppearanceYellow to orange-yellow crystalline powder
Melting point≈ 250 °C (decomposes, chars)
Solubility in waterVery slightly soluble; sparingly soluble in dilute acid and alkali
Purity (assay)96 – 102 % (dried basis, IP/BP/USP)
Loss on drying≤ 8.5 %
Residue on ignition≤ 0.3 %
Heavy metals (as Pb)≤ 20 ppm
Related substancesComplies with IP/BP/USP limits (HPLC)
Organic volatile impuritiesMeets USP requirements
pH (1 % w/v in NaOH soln)8.0 – 11.0
Specific absorbance (E 1%, 1 cm)560 – 600 at 256 nm in 0.1 M NaOH
Light sensitivitySensitive; protect from light during storage and handling
StorageCool, dry place; light-resistant containers; 15 – 25 °C
TransportNot classified as dangerous goods (Non-DG)

Applications & end uses

Industries that depend on Folic Acid

Prenatal supplements (neural tube defect prevention)

Folic acid is the cornerstone of prenatal nutrition. Adequate intake before conception and during early pregnancy significantly reduces the risk of neural tube defects such as spina bifida and anencephaly. Health authorities worldwide recommend 400 – 800 µg daily supplementation for women of childbearing age.

Multivitamin formulations

As Vitamin B9, folic acid is a standard component of multivitamin and B-complex tablets, capsules and liquid formulations. It supports DNA synthesis, red blood cell formation and amino acid metabolism, making it essential in daily health supplements.

Megaloblastic anaemia treatment

Folic acid is used in therapeutic doses to treat megaloblastic anaemia caused by folate deficiency. It restores normal erythropoiesis and is prescribed alongside Vitamin B12 assessment to avoid masking pernicious anaemia.

Food fortification (flour, cereals)

Mandatory folic acid fortification of wheat flour and cereals is implemented in over 80 countries to prevent neural tube defects at a population level. Our food-grade folic acid meets the stability and homogeneity requirements for large-scale fortification programmes.

Methotrexate rescue therapy (leucovorin precursor)

Folic acid and its reduced form folinic acid (leucovorin) are used in oncology as rescue agents during high-dose methotrexate therapy. They protect normal cells from the cytotoxic effects of antifolate chemotherapy regimens.

Animal nutrition (poultry breeding)

In poultry and livestock feed, folic acid supports embryo development, hatchability and growth performance. Feed-grade folic acid is incorporated into premixes for breeding stock and growing birds to prevent folate-deficiency-related production losses.

Available grades

Pharma, food and feed grades

≥ 97 %

Pharma grade (IP/BP/USP)

Prenatal APIs, tablet & capsule formulations

≥ 96 %

Food fortification grade

Flour, cereal and beverage fortification

≥ 95 %

Feed grade

Poultry, livestock and aquaculture premixes

!Light sensitivity notice

Folic acid is photosensitive and degrades on prolonged exposure to light. All grades must be stored in light-resistant containers in a cool, dry place (15 – 25 °C). Our packaging uses aluminium-foil inner liners and amber containers to protect potency throughout the supply chain.

Packaging options

Light-protective and pharmacopoeia-compliant

5 kg — Double HDPE bag in fibre drum (light-protective)

Small-batch pharma and R&D

25 kg — HDPE-lined fibre drum with aluminium-foil inner bag

Standard pharmaceutical unit; protects from light

Sample — Amber HDPE container (light-resistant)

QC evaluation before bulk commitment

Documentation supplied

Complete paperwork for QC and regulatory

Certificate of Analysis (COA)

Batch-specific results for assay, loss on drying, residue on ignition, heavy metals, related substances and specific absorbance.

Safety Data Sheet (SDS)

GHS-format, 16-section SDS covering handling, storage, first aid and disposal.

Specification sheet

Limit values for each test parameter aligned to IP, BP or USP monograph.

Stability data summary

Accelerated and long-term stability data confirming shelf life under recommended storage conditions.

Frequently asked questions

Common questions about Folic Acid

Which pharmacopoeia grades of Folic Acid does Chelora supply?+
We supply folic acid meeting Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) and United States Pharmacopeia (USP) monograph specifications. Food-fortification and feed grades are also available. Every batch ships with a COA confirming compliance with the relevant standard.
Why does Folic Acid need light-protective packaging?+
Folic acid is photosensitive and degrades on prolonged exposure to light, leading to loss of potency. We pack in aluminium-foil-lined drums and amber containers and recommend storing in a cool, dry place away from direct light to maintain assay throughout the shelf life.
What is the difference between Folic Acid and Folate?+
Folic acid is the synthetic, fully oxidised form of Vitamin B9 used in supplements and fortification. Folate is the general term for the family of B9 vitamers, including the natural reduced forms (e.g. 5-methyltetrahydrofolate) found in food. Folic acid is more stable and has higher bioavailability than most dietary folates.
Is your Folic Acid suitable for flour fortification programmes?+
Yes. Our food-fortification grade (≥ 96 % assay) is designed for mandatory and voluntary flour and cereal fortification. It meets the particle size, homogeneity and stability requirements for large-scale blending in flour mills.
What is the typical lead time for a bulk order?+
Standard lead time is 5 – 10 working days for domestic orders and 10 – 14 days for export, depending on grade and volume. We maintain buffer stock of pharma and food grades and can often expedite for urgent requirements.
Do you offer samples before bulk purchase?+
Yes. Sample quantities are available in light-resistant containers so your QC team can verify the material against your specification before you commit to a production order.

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