Folic Acid Powder
Alternative name: Vitamin B9
Chemical name: Butterfly acid glutamic acid
English name: Vitamin B9
Color: Light yellow crystal
Product specification: 99%
Packaging method: 1KG/aluminum foil bag, 25KG/paper tube packaging
Storage method: dry, cool, sealed, away from light, ventilated
Validity period: 24 months
Bulk Folic Acid Powder (Vitamin B9 API)
Technical Data Sheet (TDS) & Analytical Control
| Analytical Parameter | Target Specification (USP Grade) | Result | Validated Methodology |
|---|---|---|---|
| Assay (Purity) | 97.0% - 102.0% | 99.2% | HPLC |
| Appearance | Yellow to orange-yellow powder | Complies | Visual |
| Water Content | ≤ 8.5% | 6.2% | Karl Fischer |
| Related Substances | Compliant (Impurity A) | Verified | HPLC |
| Residual Solvents | Meets USP <467> limits | Pass | GC-HS |
| Heavy Metals | ≤ 10 ppm Total | < 5 ppm | ICP-MS |
Manufacturing & Engineering Advantages
Dosing Homogeneity
Folic acid is dosed in micrograms. Our precision particle-size control ensures perfect geometric dilution during tablet compression, eliminating "hot-spots" and guaranteeing every finished dose contains the exact labeled amount.
Crystal Stability & Light Shielding
Folic acid degrades upon UV exposure. We optimize the crystalline lattice structure to improve intrinsic photostability and provide light-blocking industrial packaging to safeguard the potency throughout your global supply chain.
USP/EP Regulatory Compliance
Our synthetic route is fully validated. We provide the complete regulatory dossier including impurity profile mapping, residual solvent validation, and heavy metal testing per USP monographs to ensure instant clearance for international audits.
Formulator & Procurement FAQ
Q1: How do I handle pure Folic Acid powder in micro-dosing tablets?
For tablets requiring 400mcg - 800mcg doses, mixing pure API is risky due to potential clustering. We strongly recommend our triturated (diluted) blends (e.g., 1% or 10% on maltodextrin carriers). If you prefer pure API, we provide technical guidance on specific geometric dilution steps to achieve optimal uniform blend density.
Q2: Why is the choice of crystal form/standard relevant for pharmaceutical registration?
Regulators (FDA, EMA) require that all inactive impurities (related compounds) are characterized and within limits. Our Folic Acid is manufactured to meet the specific impurity profiles defined in USP and EP monographs. This means your regulatory team can use our COA and synthesis dossier to verify the impurity specs, saving you months of development time.
Q3: How should I store this API to prevent degradation?
Folic Acid is highly light-sensitive and moderately moisture-sensitive. Store the bulk API in its original, light-blocking fiber drums in a cool, dark, and dry environment. We provide double-bagged, oxygen-barrier inner packaging to ensure the 24-month stability shelf life remains intact.
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