Ferric Carboxymaltose
Introduction:
Ferric carboxymaltose is a new type of intravenous iron preparation, which is a complex formed by a trivalent polynuclear iron core (β-FeOOH) surrounded by carboxymaltodextrin (the oxidation product of maltodextrin) (codenamed "VIT- 45"), this core-shell structure can stably complex iron and control the release of iron, thus preventing toxic oxides produced by saturation of ferroportin and ferritin due to excessive blood iron concentration. Iron carboxymaltose contains high iron content (24-32%, the iron content in its injection is 47.5-52.5mg/mL, and 500-1500mg of iron can be quickly injected within 15 minutes), the frequency of administration is small, and the iron supplement effect is good and large. It improves patient compliance to a certain extent and is a good intravenous iron supplement.
Specifications:
| Test Items | Specifications | |
| Description | Red-brown powder | |
| Identification | A: Iron (Ferric) | Positive |
| B: Dextrin | Meets the requirements | |
| C: Molecular Weight determination | Mw=110,000~230,000 Da Mn≥60,000 Da Mw/Mn≤1.9 |
|
| pH Value | 5.0 ~ 7.0 | |
| Loss on Drying | Not more than 10.0% | |
| Content of Chloride | Not more than 6.0% | |
| Limit of Iron (Ⅱ) | Not more than 1.2% | |
| Arsenic (As) | Not more than 11 ppm | |
| Cuprum (Cu) | Not more than 320 ppm | |
| Lead (Pb) | Not more than 135 ppm | |
| Microbial Limits | Total aerobic microbial count | Not more than 100 CFU/g |
| Moulds & Yeasts | Not more than 10 CFU/g | |
| Escherichia coli, Staphylococcus aureus and Pseudomonas aeruginosa | Negative/g | |
| Salmonella | Negative/10g | |
| Bacterial endotoxins | Less than 0.1 EU/mg Iron | |
| Assay for Iron | 24.0% ~ 32.0% (on the anhydrous basis) | |
| Assay for dextrin (as glucose) | 25.0% ~ 50.0% (on the anhydrous basis) | |
Packaging:
1kg/Aluminum Foil Bag or 10kg/Carton.
Storage Conditions:
Preserved in unopened original containers in a cool dry place before using; kept away from direct sunlight, heat and moisture.
Shelf Life:
36 months if stored under above mentioned conditions.
