Certificate of Analysis and technical specification for Ferric Hydroxide Polymaltose Complex — CAS 9004-66-4. Applies to all consignments of this product and grade.
| Product Name | Ferric Hydroxide Polymaltose Complex |
|---|---|
| C.A.S. Number | 9004-66-4 |
| Product Category | Vitamins, Minerals & Amino Acids |
| Product Group | Iron Supplements |
| Grade / Standard | ≥98% Pharma Grade |
| Physical Form | Dark brown powder |
| Country of Origin | India |
| Packing | Standard export packing — bags, drums, carboys, IBC or ISO tank as applicable |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
| S. No. | Test Parameter | Specification | Typical Result | Method |
|---|---|---|---|---|
| 1 | Description | Dark brown powder | Complies | Visual |
| 2 | Identification | Conforms to the structure of the substance | Complies | FTIR / Chemical test |
| 3 | Solubility | As per specification | Complies | Visual / Monograph |
| 4 | Assay | Not less than 98.0 % w/w | 99.03 | Titrimetry / Instrumental |
| 5 | Specific Optical Rotation | As per monograph | Conforms | Polarimetry |
| 6 | Loss on Drying | Not more than 0.5 % w/w | 0.22 | Gravimetry |
| 7 | Residue on Ignition | Not more than 0.1 % w/w | 0.033 | Gravimetry |
| 8 | Chloride | Not more than 0.05 % | 0.0045 | Turbidimetry |
| 9 | Lead (Pb) | Not more than 3 ppm | Less than 0.5 ppm | ICP-MS |
| 10 | Heavy Metals (as Pb) | Not more than 10 ppm | Less than 5 ppm | ICP-OES |
| 11 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 108 cfu/g | IP / USP <61> |
| 12 | Total Yeast & Mould Count | Not more than 100 cfu/g | 15 cfu/g | IP / USP <61> |
| 13 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 14 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
This document sets out the standard specification for Ferric Hydroxide Polymaltose Complex and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.
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