| HS Code | 896368 |
| Product Name | Ferrous Bisglycinate Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Active Ingredient | Ferrous Bisglycinate |
| Synonyms | Iron bisglycinate; Ferrous glycinate; Iron(II) glycinate |
| Chemical Name | Iron(II) bis(glycinate) |
| Cas Number | 20150-34-9 |
| Molecular Formula | C4H8FeN2O4 |
| Molecular Weight | 203.96 g/mol |
| Iron Content Typical Pharma Grade | 20% w/w |
| Iron Content Theoretical | 27.4% w/w |
| Appearance | White to off-white or light green powder |
| Odor | Odorless |
| Solubility | Sparingly soluble in water; practically insoluble in ethanol and organic solvents |
| Ph | 4.0 to 7.0 (1% aqueous suspension) |
| Assay | 98.0% to 102.0% (as ferrous bisglycinate) or 20.0% to 22.0% elemental iron |
| Purity | ≥98.0% |
| Loss On Drying | ≤5.0% |
| Water Content | ≤5.0% |
| Particle Size | 90% passes 80 mesh |
| Particle Size Distribution | D50 10-50 µm |
| Bulk Density | 0.4 to 0.8 g/mL |
| Tap Density | 0.5 to 0.9 g/mL |
| Flowability | Good |
| Compressibility | Good |
| Heavy Metals | ≤10 ppm |
| Arsenic | ≤2 ppm |
| Lead | ≤2 ppm |
| Cadmium | ≤1 ppm |
| Mercury | ≤0.1 ppm |
| Elemental Impurities | Meets ICH Q3D |
| Residual Solvents | Meets USP <467> |
| Microbial Limits | Total aerobic count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; E. coli absent |
| Microbial Quality | Meets USP <61> and <62> |
| Endotoxin | ≤5 EU/mg (for injectable grade) |
| Sterility | Sterile (for injectable grade) |
| Pyrogenicity | Pyrogen-free (for injectable grade) |
| Identification | IR, HPLC, ICP-MS |
| Grade | Pharma Grade |
| Dosage Forms | Tablet, Capsule, Granule, Injection |
| Route Of Administration | Oral, Injectable |
| Therapeutic Category | Antianemic, Iron Supplement |
| Usage | Treatment and prevention of iron deficiency anemia |
| Contraindications | Hemochromatosis, hemosiderosis, hemolytic anemia |
| Storage Conditions | Store in a cool, dry place, protected from light and moisture |
| Shelf Life | 2 years |
| Packaging | 25 kg fiber drum with double polyethylene bags |
| Standard | USP/NF, EP, JP, IP or in-house |
| Regulatory Status | Pharmaceutical API |
| Stability | Stable under recommended storage conditions |
| Incompatibilities | Strong oxidizing agents |
| Handling Precautions | Avoid inhalation and contact; use appropriate PPE |
As an accredited Ferrous Bisglycinate Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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Competitive Ferrous Bisglycinate Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8615365186327 or mail to admin@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8615365186327
Email: admin@ascent-chem.com
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