Ferrous Fumarate (IP/BP/USP/EP)
| PRODUCT NAME | FERROUS FUMARATE – IP/BP/USP/EP |
| Chemical formula | C4H2FeO4 |
| Molecular weight | 169.90 |
| Standard pack size | 25 KG. PAPER BAG / 50 KG. HDPE BAG |
| Retest period | 5 Years from the date of manufacture |
| Application |
| No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | A Reddish orange to reddish Brown, fine Powder may contain soft lumps that Produce a yellow streak when crushed; Odor, slight. | IP |
| 2. | Solubility | Slightly Soluble in Water; very slightly soluble in ethanol (96%) | IP |
| 3. | Identification | A) Filtrate gives reaction a of ferrous salt. (B) Potassium permanganate is Decolorized and A brownish solution is obtained. (C) An orange-yellow solution without any fluorescence is obtained | IP |
| 4. | ARSENIC | Not more than 5 ppm | IP |
| 5. | HEAVY METALS | Not more than 20 ppm. | IP |
| 6. | SULPHATE | Not more than 0.1%. | IP |
| 7. | FERRIC IRON | Not more than 2.0 %. | IP |
| 8 | LOSS ON DRYING | Not more than 1.0%. | IP |
| 9 | ASSAY | NLT 93.0% & NMT 101.0% | IP |
| No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | Fine Reddish orange or reddish Brown Powder. | BP |
| 2. | Solubility | Slightly Soluble in Water; very slightly soluble in ethanol (96%) | BP |
| 3. | Identification | (A) The principle spot in the Chromatogram obtained with the test solution is similar in position and size to the principle spot in the chromatogram obtained with the Reference solution. (B) An orange-yellow color develops and the solution shows no Fluorescence. (©The obtained for the Test solution in identification test A shows reaction (a) of iron. | BP |
| 4. | Sulphate | Not more than 0.2%. | BP |
| 5. | Arsenic | Not more than 5 ppm. | BP |
| 6. | Ferric iron | Not more than 2.0 %. | BP |
| 7. | Cadmium | Not more than 10 ppm. | BP |
| 8 | Chromium | Not more than 200 ppm. | BP |
| 9 | Lead | Not more than 20 ppm. | BP |
| 10 | Mercury | Not more than 1 ppm | BP |
| 11 | Nickel | Not more than 200 ppm. | BP |
| 12 | Zinc | Not more than 500 ppm. | BP |
| 13 | Lod | Not more than 1.0 %. | BP |
| 14 | Assay (On Dry Basis) | NLT 93.0% & NMT 101.0% | BP |
| No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | Reddish -orange to red Brown, Odourless Powder. May contain soft lumps that Produce a yellow streak when crushed. | USP |
| 2. | Solubility | Slightly Soluble in Water; very slightly soluble in alcohol. Solubility in dilute hydrochloride acid is limited by the separation of Fumaric acid | USP |
| 3. | Identification | (A) The IR absorption of a potassium bromide dispersion of the dried precipitate exhibits maxima only at the same wavelengths as that of a similar preparation of USP Fumaric Acid RS. (B) A portion of the filtrate obtained in identification test A meets the requirements. | USP |
| 4. | Lod | Not more than 1.5 %. | USP |
| 5. | Sulphate | Not more than 0.2%. | USP |
| 6. | Arsenic | Not more than 3 ppm. | USP |
| 7. | Ferric iron | Not more than 2.0 %. | USP |
| 8. | Lead | Not more than 10 ppm | USP |
| 9. | Mercury | NMT 3 ppm | USP |
| 10. | Assay(on dry basis) | NLT 97.0% & NMT 101.0% | USP |
| No. | TEST | SPECIFICATION | REFERENCE |
| 1. | Description | Fine, Reddish orange or reddish Brown Powder. | EP |
| 2. | Solubility | Slightly Soluble in Water; very slightly soluble in ethanol (96%) | EP |
| 3. | Identification | (A) TLC The principle spot in the Chromatogram obtained with the test solution is similar in position and size to the principle spot in the chromatogram obtained with the working standard solution. (B) An orange-yellow color develops and the solution shows no Fluorescence. © The filtrate obtained during preparation of test solution in the identification test A shows reaction (a) of iron | EP |
| 4. | Sulphate | Not more than 0.2%. | EP |
| 5. | Arsenic | Not more than 5 ppm. | EP |
| 6. | Ferric iron | Not more than 2.0 %. | EP |
| 7. | Cadmium | Not more than 10 ppm. | EP |
| 8 | Chromium | Not more than 200 ppm. | EP |
| 9 | Lead | Not more than 20 ppm. | EP |
| 10 | Mercury | Not more than 1 ppm | EP |
| 11 | Nickel | Not more than 200 ppm. | EP |
| 12 | Zinc | Not more than 500 ppm. | EP |
| 13 | Lod | Not more than 1.0 %. | EP |
| 14 | Microbial contamination | Total aerobic microbial count (1AMC) 103CFU per 1g Total yeast and mould count (1YMC) 102CFU per 1g | EP |
| 15 | Assay (On Dry Basis) | Not Less than 93.0% &Not More than 101.0% | EP |