| Diethanolamine USP-NF PARENTEX PLUS 25L | |||
| I7553LL025 | 45644F728BY | ||
| USP-NF PARENTEX PLUS | 45644F7 | ||
| 111-42-2 | 110606 | ||
| C4H11NO2 | February 2025 | ||
| 105.14 | January 2028 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Description | Clear, colorless liquid, deliquescing in moist air. | A White or clear, colorless liquid or crystals, deliquescing in moist air. | USP-NF |
| 2 | Solubility | Complies | Miscible with water, with alcohol, with acetone, with chloroform, and with glycerin. Slightly soluble to insoluble in benzene, in ether, and in petroleum ether. | USP-NF |
| 3 | Identification by IR | Complies | IR spectra of the sample should concomitant with IR spectra of the standard | USP-NF |
| 4 | Refractive index (at 30°C) | 1.474 | 1.473 - 1.476 | USP-NF |
| 5 | Water | 0.051% | NMT 0.15% | USP-NF |
| 6 | Limit of Triethanolamine | 0.56% | NMT 1.0% | USP-NF |
| 7 | Assay (Anhydrous basis) | 99.80% | 98.5% - 101.0% | USP-NF |
| 8 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 9 | Total combined yeast and molds count | Less than 10 CFU/ml | NMT 10 CFU/ml | In-house |
| 10 | Bacterial endotoxins | Less than 2.5 EU/ml | NMT 2.5 EU/ml | In-house |
| 11 | E.coli | Absent/ml | should be absent/ml | In-house |
| 12 | Pseudomonas aeruginosa | Absent/ml | should be absent/ml | In-house |
| 13 | S.aureus | Absent/ml | should be absent/ml | In-house |
| 14 | Bile-tolerant gram negative bacteria | Absent/ml | should be absent/ml | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF SPECIFICATION.
Actylis 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.
