| N,N-Dimethyl acetamide CDMF PARENTEX PLUS 2.5LT | |||
| I3590LC250 | 38803B426IV | ||
| CDMF PARENTEX PLUS | 38803B4 | ||
| 127-19-5 | 89068 | ||
| CH3CON(CH3)2 | September 2022 | ||
| 87.12 | August 2024 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear, colourless liquid with a characteristic odour. | Clear colourless liquid with a chracteristic odour |
| 2 | Appearance | Complies | The substance to be examined is clear and not more intensely coloured than reference solution Y7. |
| 3 | Miscibility | Complies | Miscible with ethanol (95%), water & most common solvent |
| 4 | Identification by IR | Complies | IR spectra of the sample should be concomittant with IR spectra of the corresponding standard. |
| 5 | Identification by Chemical test | Complies | A reddish-brown colour develop, reaching a maximum intensity after about 5 min |
| 6 | Boiling range (95%) | 164.5°C to 167.5°C | 164.5°C to 167.5°C |
| 7 | Relative density, 20°C | 0.942 | 0.941 to 0.944 |
| 8 | Refractive index (20°C ± 0.5°C) | 1.438 | 1.437 - 1.438 |
| 9 | Acidity | Complies | NMT 5.0 mL of 0.02M potassium hyrodxide should require to restore the initia (Bluish-green) colour |
| 10 | Alkalinity | Complies | NMT 0.5 mL of 0.02M hydrochloric acid should require to restore the initial (Yellow) colour |
| 11 | Non-volatile matter | 8ppm | NMT 20ppm |
| 12 | Chloride (Cl) | Less than 10ppm | NMT 10ppm |
| 13 | Sulphate (SO4) | Less than 10ppm | NMT 10ppm |
| 14 | Lead (Pb) | 0.13ppm | Not more than 0.5ppm |
| 15 | Arsenic (As) | Not detected | NMT 1.5ppm |
| 16 | Cadmium(Cd) | Not detected | NMT 0.2ppm |
| 17 | Mercury(Hg) | Not detected | NMT 0.3ppm |
| 18 | Related substances (Any impurity) | 0.03% | NMT 0.1% |
| 19 | Related substances (Total impurity) | 0.04% | NMT 0.3% |
| 20 | UV absorbance profile (10mm cell)@270nm | 0.620 | NMT 1.0 |
| 21 | UV absorbance profile (10mm cell)@300nm | 0.030 | NMT 0.1 |
| 22 | UV absorbance profile (10mm cell)@360nm | 0.001 | NMT 0.01 |
| 23 | Purity (By GC) | 99.92% | NLT 99.8% |
| 24 | Water (By KF) | 0.048% | NMT 0.1% (w/w) |
| 25 | Bacterial endotoxins | Less than 2.0 EU/mL | NMT 2.0 EU/mL |
| 26 | Total aerobic bacterial count | Less than 100 CFU/mL | NMT 100 CFU/mL |
| 27 | Total combined yeast and molds count | Less than 10 CFU/mL | NMT 10 CFU/mL |
| 28 | E.coli | Absent/mL | should be absent/mL |
| 29 | Salmonella | Absent/10 mL | should be absent/10 mL |
| 30 | Pseud. aeruginosa | Absent/mL | should be absent/mL |
| 31 | Staphylococcus aureus | Absent/mL | should be absent/mL |
| 32 | Bile-tolerant gram negative bacteria | Absent/mL | should be absent/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.
