| Dimethyl acetamide Ph.Eur PARENTEX 2LT | |||
| P6590LC200 | 44835G708KX | ||
| Ph.Eur PARENTEX | 44835G7 | ||
| 127-19-5 | 108084 | ||
| CH3CON(CH3)2 | November 2024 | ||
| 87.12 | October 2027 | ||
| Sr.No. | Test | Result | Specification | Method Reference |
|---|---|---|---|---|
| 1 | Appearance | Clear, colourless, slightly hygroscopic liquid. | Clear, colourless, slightly hygroscopic liquid. | Ph.Eur |
| 2 | Solubility | Complies | Miscible with water, with ethanol (96 per cent), and with most common organic solvents. | Ph.Eur |
| 3 | Boiling point | 166°C | About 165°C | Ph.Eur |
| 4 | Identification A ( By Relative density, 20°C) | 0.943 | 0.941 - 0.944 | Ph.Eur |
| 5 | Identification B (By Refractive index, 20±0.5°C) | 1.437 | 1.435 - 1.439 | Ph.Eur |
| 6 | Identification C (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. | Ph.Eur |
| 7 | Identification D (By Chemical test) | Complies | A reddish-brown color develops, reaching a maximum intensity after about 5 minutes. | Ph.Eur |
| 8 | Appearance of solution | Clear, colorless slightly hygroscopic liquid. | Clear and not more intensely coloured than reference solution Y7 | Ph.Eur |
| 9 | Acidity | 1.2ml of 0.02M potassium hydroxide required | NMT 5.0ml of 0.02M potassium hydroxide is required to restore the initial bluish-green color. | Ph.Eur |
| 10 | Alkalinity | 0.3ml of 0.02M hydrochloric acid required | NMT 0.5ml of 0.02M hydrochloric acid is required to restore the initial yellow color. | Ph.Eur |
| 11 | Related substances (Any impurity) | 0.02% | NMT 0.1% | Ph.Eur |
| 12 | Related substances (Total impurity) | 0.03% | NMT 0.3% | Ph.Eur |
| 13 | Non-volatile matter | 12ppm | NMT 20ppm | Ph.Eur |
| 14 | Water (By KF) | 0.072% | NMT 0.1% | Ph.Eur |
| 15 | Bacterial endotoxin | Less than 0.2 EU/mg | NMT 0.2 EU/mg | In-house |
| 16 | Total aerobic bacterial count | Less than 100 CFU/ml | NMT 100 CFU/ml | In-house |
| 17 | Total Yeast and mold count | Less than 10 CFU/ml | NMT 10 CFU/ml | In-house |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS Ph.Eur 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.
