| Edetate calcium disodium USP 500GM | |||
| 90656SG500 | 431621819CX | ||
| USP | 4316218 | ||
| 23411-34-9 | 102135 | ||
| C10H12CaN2Na2O8.XH2O | March 2024 | ||
| 374.27 XH2O | February 2027 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White crystalline powder, odourless, slightly hygroscopic, and has a faint, saline taste. Stable in air. | White crystalline granules or white, crystalline powder, odourless, slightly hygroscopic, and has a faint, saline taste. Stable in air. |
| 2 | Solubility | Complies | Freely soluble in water. |
| 3 | Identification A (By IR) | Complies | IR spectrum of sample should be concomitant with IR spectrum of standard |
| 4 | Identification B (By Chemical test) | Complies | A white precipitate should form. |
| 5 | Identification C (By Chemical test) | Complies | A white crystalline precipitate should form. |
| 6 | Assay (Anhydrous basis) | 99.4% | 98.0% - 102.0% |
| 7 | Chloride (Cl) | Less than 0.10% | NMT 0.10% |
| 8 | Organic impurities; disodium Edetate | Less than 1.0% | NMT 1.0% |
| 9 | Limit of Nitrilotriacetic acid | 0.035% | NMT 0.1% |
| 10 | pH (1 in 5) | 6.76 | 6.5 - 8.0 |
| 11 | Water | 9.6% | 5.0% - 13.0% |
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
| Tested By (Chemist - Quality Control) | Approved By (Head - Quality Control) |
Computer Generated Report - Does not require Signature.
