Calcium Folinate, USP
Product Description
| Product | Calcium Folinate, USP |
| CAS | 1492-18-8 |
| Formula | C20H 21CaN7O7 |
| Synonym | Leucovorin Calcium |
Typical Product Specifications
| Purity Test, 5-formyltetrahydropteoric acid | NMT 1.0% |
| Absorbance (420nm) | NMT 0.60 |
| Purity Test 7,8-dihydrofolic acid | NMT 1.0% |
| Water Content (by Karl Fischer) | NMT 17.0% |
| Sieve analysis, particles<100 um | NLT 80% |
| Sieve analysis, particles>200 um | NMT 10% |
| Tapped Density | 0.45 - 0.75 g/ml |
| Optical rotation, 2.5% in H2O | 14.4-18.0° |
| Purity Test, 10-formylfolic acid | NMT 1.0% |
| Appearance of solution (2.5 aqueous solution) | Clear |
| Sum impurities | NMT 2.0% |
| Loose Density | 0.20 - 0.50 g/ml |
| Appearance | White to light yellow powder |
| Total Aerobic Microbial Count | NMT 500 cfu/g |
| IR spectrum | Comparable to reference spectrum |
| Purity Test, p-aminobenzoylglutamic acid | NMT 1.0% |
| Residual methanol | NMT 0.3% |
| Heavy Metals | NMT 50ppm |
| Bacterial endotoxins (LAL test) | NMT 0.350EU/mg |
| Purity Test, folic acid | NMT 1.0% |
| Purity Test, Individual unidentified impurities | NMT 0.1% |
| Chlorides | NMT 0.5% |
| Purity Test, 10-formyltetrahydrofolic acid | NMT 1.0% |
| Total molds and yeast | NMT 100 cfu/g |
| Platinum | NMT 20ppm |
| Residual acetone | NMT 0.5% |
| Purity Test 5,10-diformyltetrahydrofolic acid | NMT 1.0% |
| pH (2.5% aqueous solution) | 6.8-8.0 |
| Color value (1% aqueous solution) | NMT 250 APHA |
| Residual ethanol | NMT 0.5% |
| Assay, Calcium Folinate (by HPLC) | 97.0 - 102.0% |
| Assay, Calcium | 7.54 - 8.14% |
| Notes | Store at up to 25C in an airtight container. Do not freeze. |
| Class | Active Pharmaceutical Ingredients (API) & Intermediates |
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