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Vitamins / Nutritional

Folic Acid API Supplier

CAS 59-30-3  ·  Vitamins / Nutritional · B9 · Oncology Support

GMP-certified Folic Acid (Vitamin B9) API in pharmaceutical grade. USP and Ph.Eur. compliant. cGMP ICH Q7 manufactured. Emprove-grade documentation package available on request.

Request Complete Source Quote View Specifications
Purity≥99.5%HPLC
MOQ5 kgcGMP / Emprove-grade docs
RegulatoryUSP / Ph.Eur.cGMP ICH Q7
Response24 hrFull dossier
OriginMultiIndia / China
Technical Specifications

Folic Acid API — Full Technical Profile

INN / Generic NameFolic Acid
CAS Number59-30-3
Molecular FormulaC₁₉H₁₉N₇O₆
Molecular Weight441.4 g/mol
Mechanism / ClassFolate / Vitamin B9 — cofactor for nucleotide synthesis and methylation reactions
Therapeutic UseFolate deficiency, neural tube defect prevention, oncology support, prenatal vitamins
Purity (HPLC)≥99.5%
AppearanceYellow to orange-yellow crystalline powder; odourless
StorageStore below 25°C; protect from light and moisture
MOQ (commercial)5 kg
MOQ (R&D)100 g – 500 g
Lead Time2–4 weeks
Regulatory FilingsUSP / Ph.Eur.
Country of OriginIndia / China
Regulatory Documentation

Complete Source Quote — What's Included

Every Folic Acid API inquiry returns a complete regulatory package in 24 hours.

📋
Certificate of Analysis
Full CoA — assay ≥99.5%, heavy metals, residual solvents, particle size distribution, loss on drying.
✓ Included
📖
USP / Ph.Eur. Compliance
Manufactured and tested against both USP and European Pharmacopoeia monographs.
✓ Dual-compendial
🏭
cGMP ICH Q7
Manufactured under current GMP in compliance with ICH Q7 Active Pharmaceutical Ingredient guidance.
✓ Certified
📁
Emprove-Grade Docs
Extended documentation package — master production record summaries, process validation overview, supply chain traceability — available on request.
On Request
📊
Stability Data
ICH Q1A stability data at 25°C/60% RH (long-term) and 40°C/75% RH (accelerated). Photostability data included.
✓ Included
🧪
Impurity Profile
Full related substances characterisation — pteridine, aminobenzoic acid derivatives, and synthesis-related impurities.
✓ Included
Market Context

Folic Acid — Key Figures

$500M+
Global folic acid market
USP + Ph.Eur
Dual pharmacopoeial
5 kg
Commercial MOQ
2–4 wk
Lead time
Complete Source Quote

Get Your Folic Acid API Quote

Submit your requirements. We'll respond with a complete package within 24 business hours.

  • Certificate of Analysis (CoA)
  • USP / Ph.Eur. — reference letter / status
  • Full impurity profile per ICH Q3A
  • Stability data summary
  • GMP certificate + site details
  • Pricing, MOQ, and lead time
  • Country of origin confirmation
Folic Acid API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Folic Acid API — FAQ

Is Folic Acid available in both USP and Ph.Eur. grades?
Yes — our Folic Acid API is manufactured and tested against both USP and European Pharmacopoeia (Ph.Eur.) monographs, providing a single source suitable for both US and European formulations.
What is 'Emprove-grade' documentation?
Emprove-grade refers to an extended documentation package that includes master production record summaries, process validation data, supply chain maps, and risk assessments — originally developed by Sigma-Aldrich/Merck. We can provide equivalent documentation on request for buyers with enhanced supply chain requirements.
Is pharmaceutical-grade Folic Acid suitable for injectable formulations?
Pharmaceutical-grade Folic Acid is used in both oral solid and parenteral formulations. For injectable-grade, additional testing for particulate matter, endotoxins, and sterility indicators is required — we can confirm injectable-specific specifications at the quote stage.
Does Generic Specialty Group manufacture Folic Acid?
No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.
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