Ferric Sodium Edta FCC
| PRODUCT NAME | FERROUS GLUCONATE –IP/BP/USP |
| Chemical formula | C12H24FeO14 |
| Molecular weight | 446.1 |
| Standard pack size | 25 KG. PAPER BAG / 50 KG. HDPE BAG |
| Retest period | 5 Years from the date of manufacture |
| Application |
| Sr.No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | A yellowish grey or pale greenish yellow, fine powder or granules, odor, slight, resembling that of burnt sugar | IP |
| 2. | Solubility | Freely but slowly soluble in water; more readily soluble on warming; Practically insoluble in ethanol (95%) | IP |
| 3. | Identification A. Identification tests-general (2.3.1[a]) B. Thin layer chromatography | Complies IP Complies IP | IP |
| 4. | pH | 4.0 to 5.5 | IP |
| 5. | Loss on drying | 5.0% to 10% | IP |
| 6. | Appearance of solution | As per IP | IP |
| 7. | Arsenic | NMT 2 ppm | IP |
| 8. | Heavy metals | NMT 20 ppm | IP |
| 9. | Chloride | NMT 625 ppm | IP |
| 10 | Sulphates | NMT 500 ppm | IP |
| 11. | Barium | As per IP | IP |
| 14. | Ferric iron | NMT 1.0% | IP |
| 15. | Oxalic acid | As per IP | IP |
| Reducing substance | As per IP | ||
| 16. | Microbial contamination | NMT 103 ppm | IP |
| 17. | Contamination tymc | Aerobic count | IP |
| 18. | Assay | 95.0%-102.0% | IP |
| Sr. No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | Greenish- yellow or grey powder or granules | BP |
| 2. | Solubility | Freely but slowly soluble in water giving a greenish brown solution, morw readily soluble in hot ater, practically insoluble in ethanol. | BP |
| 3. | Identification A. Thin – layer chromatography B. Test B | Shall Pass the test Shall Pass the test | BP |
| 4. | Appearance of solution | Clear | BP |
| 5. | pH | 4.0 to 5.5 | BP |
| 6. | Loss on drying | 5.0% to 10.5% | BP |
| 7. | Chloride | Max. 0.06% | BP |
| 8. | Oxalic acid | Shall Pass the test | BP |
| 9. | Sulphate | Max. 500 ppm | BP |
| 10 | Arsenic | Max. 2 ppm | BP |
| 11. | Limit Ferric iron | Max. 1.0% | BP |
| 14. | Heavy Metals | Max.20 ppm | BP |
| 15. | Reducing Sugars | Shall Pass the test | BP |
| 16. | Barium | Shall Pass the test | |
| 17. | Assay iron (II) (dried substance) | 11.8% to 12.5% | BP |
| Sr. No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | Yellowish grey or pale greenish yellow, fine powder or granules, having a slight odor , resembling that of burned sugar | USP |
| 2. | Solubility | Soluble in water, with slight heating;practically insoluble in alcohol | USP |
| 3. | Identification C. Thin – layer chromatography D. Test B | Shall Pass the test Shall Pass the test | USP |
| 4. | Loss on drying | 6.5% to 10.0% | USP |
| 5. | Chloride | NMT 0.07% | USP |
| 6. | Oxalic acid | Shall Pass the test | USP |
| 7. | Sulphates | NMT 0.1% | USP |
| 8. | Arsenic | NMT 3ppm | USP |
| 9. | Limit Ferric iron | NMT 2.0% | USP |
| 10 | Limit of Lead | NMT 0.001% | USP |
| 11. | Mercury | NMT 3 ppm | USP |
| 14. | Reducing Sugars | Shall Pass the test | USP |
| 15. | Assay | 97.0% to 102.0% | USP |