Pharmaceutical Materials

Folic Acid Overview

Category	Details
Basic Information
– Chemical Name	Pteroylglutamic Acid (Vitamin B9).
– CAS Number	59-30-3.
– Molecular Formula	C₁₉H₁₉N₇O₆.
– Molecular Weight	441.40 g/mol.
– Appearance	Yellow crystalline powder; slightly soluble in water; degrades in alkaline pH.
Biological Role
– Key Functions	Cofactor in DNA synthesis; supports cell division; aids methylation processes.
– Deficiency Risks	Megaloblastic anemia; neural tube defects (NTDs) in pregnancy.
Applications
– Pharmaceutical	Prenatal vitamins; anemia treatments.
– Food Fortification	Enriched cereals; dietary supplements.
– Agricultural	Livestock feed additive.
Safety & Storage
– Daily Intake Limits	Adults: 400–800 μg (varies by region); avoid overdose (>1,000 μg/day).
– Storage Conditions	Cool (<25°C), dry, light-protected; shelf life 24 months.
Regulatory Compliance	USP/NF, EP, JP; GRAS status for food use.

Summary:

Folic acid is a water-soluble vitamin essential for DNA replication and cellular growth. It acts as a coenzyme in nucleotide biosynthesis and plays a critical role in preventing birth defects during early pregnancy. Commercially, it is used in prenatal supplements, fortified foods, and animal feed. Stability is compromised in moisture and light, necessitating controlled storage. Regulatory bodies set strict guidelines for its use in healthcare and food industries.

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