| Dimethyl acetamide Ph.Eur PARENTEX 2.5LT | |||
| P6590LC250 | 37617G724DV | ||
| Ph.Eur PARENTEX | 37617G7 | ||
| 127-19-5 | 85331 | ||
| CH3CON(CH3)2 | April 2022 | ||
| 87.12 | March 2025 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear, colorless, slightly hygroscpic liquid. | Clear, colourless, slightly hygroscopic liquid. |
| 2 | Solubility | Passes | Miscible with water, with ethanol (96 per cent). |
| 3 | Boiling point | 165°C | ~165°C |
| 4 | Identification A ( By Relative density, 20°C) | 0.942 | 0.941 - 0.944 |
| 5 | Identification B (By Refractive index, 20±0.5°C) | 1.438 | 1.435 - 1.439 |
| 6 | Identification C (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
| 7 | Identification D (By Chemical test) | Complies | A reddish-brown color develops, reaching a maximum intensity after about 5 minutes. |
| 8 | Appearance of solution | Passes | The solution is clear and not more intensely coloured than reference solution Y7 |
| 9 | Acidity | 3.0ml of 0.02M potassium hydroxide | NMT 5.0ml of 0.02M potassium hydroxide is required to restore the initial bluish-green color. |
| 10 | Alkalinity | 0.2ml of 0.02M hydrochloric acid | NMT 0.5ml of 0.02M hydrochloric acid is required to restore the initial yellow color. |
| 11 | Related substances (N,N-dimethylformamide) | 0.004% | NMT 0.07% |
| 12 | Related substances (Any impurity) | 0.02% | NMT 0.1% |
| 13 | Related substances (Total impurity) | 0.03% | NMT 0.3% |
| 14 | Heavy metals | Less than 10 ppm | NMT 10 ppm |
| 15 | Non-volatile matter | 8 ppm | NMT 20 ppm |
| 16 | Water (By KF) | 0.04% | NMT 0.05% |
| 17 | Bacterial endotoxins | Less than 0.2 EU/mg | NMT 0.2 EU/mg |
| 18 | Total aerobic bacterial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
| 19 | Total combined yeast and molds count | Less than 10 CFU/ml | NMT 10 CFU/ml |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS Ph.Eur 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.
