| Disodium edetate anhydrous USP PARENTEX 5KG | |||
| P2035SR500 | 42688H219AX | ||
| USP PARENTEX | 42688H2 | ||
| 139-33-3 | 101062 | ||
| C10H14N2Na2O8 | January 2024 | ||
| 336.21 | December 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | White, crystalline powder. | White, crystalline powder. |
| 2 | Solubility | Complies | Soluble in water. |
| 3 | Identification A (By IR) | Complies | To Comply the test |
| 4 | Identification B (By Chemical test) | Complies | the red color is discharged, leaving a yellow solution. |
| 5 | Identification C (By Chemical test) | Complies | Positive test for Sodium |
| 6 | Assay (on dried basis) | 99.6% | 99.0% - 101.0% |
| 7 | Calcium (Ca) | Complies | No precipitate is formed. |
| 8 | Limit of Nitrilotriacetic acid | Complies | Not more than 0.1% |
| 9 | pH | 4.49 | 4.0-6.0 |
| 10 | Total bacterial count | Less than 100 cfu/g | 100 cfu/g max |
| 11 | Total Fungal count | Less than 10 cfu/g | 10 cfu/g max |
| 12 | Pseud. aeruginosa | Absent/g | Absent/g |
| 13 | Salmonella | Absent/10g | Absent/10g |
| 14 | Staphylococcus aureus | Absent/g | Absent/g |
| 15 | E.coli | Absent/g | Absent/g |
| 16 | Bile-tolerant gram negative bacteria | Absent/g | Absent/g |
| 17 | Becterial endotoxins test | Less than 30 EU/gm | 30 EU/gm max. |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS 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.
