| Methylene chloride CDMF PARENTEX PLUS 2.5LT | |||
| I3550LC250 | 42225B402KW | ||
| CDMF PARENTEX PLUS | 42225B4 | ||
| 75-09-2 | 98932 | ||
| ClCH2Cl | November 2023 | ||
| 84.93 | October 2026 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance | Clear,colourless, volatile liquid having an odor resembling that of chloroform. | Clear,colourless, volatile liquid having an odor resembling that of chloroform. |
| 2 | Solubility | Complies | Sparingly soluble in water, miscible with ethanol (96%) alcohol, with ether, and with fixed and volatile oils. |
| 3 | Identification A (Relative density, 20°C) | 1.322 | 1.320 to 1.332 |
| 4 | Identification B (Refractive index, 20±0.5°C) | 1.424 | 1.423 to 1.425 |
| 5 | Identification C (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
| 6 | Identification D (By chemical test) | Complies | A violet color should produce. |
| 7 | Identification E (By Chemical test) | Complies | The precipitate should dissolve easily with the possible exception of a few large particles which dissolve slowly. |
| 8 | Appearance of solution | Complies | Clear and colorless |
| 9 | Relative density, 20°C | 1.322 | 1.320 to 1.332 |
| 10 | Specific gravity,25°C | 1.320 | Between 1.318 and 1.322 |
| 11 | Refractive index, 20°C ± 0.5°C | 1.424 | 1.423 to 1.425 |
| 12 | Assay | 99.98% | NLT 99.0% |
| 13 | Acidity | Complies | Not more than 0.15 mL of 0.1M sodium hydroxide is required to change the color of the indicator to blue. ( |
| 14 | Limit of hydrogen chloride | Less than 0.001% | NMT 0.001% |
| 15 | Free Chlorine (Cl) | Complies | The lower layer does not show a violet tint. |
| 16 | Ethanol, 2-methylbut-2-ene and volatile impurities: Ethanol | Not detected | NMT 2.0% v/v |
| 17 | Ethanol, 2-methylbut-2-ene and volatile impurities: 2-methylbut-2-ene | 14 ppm | NMT 300 ppm v/v |
| 18 | Impurity A (Carbon tetrachloride) | Not detected | NMT 4 ppm v/v |
| 19 | Impurity B (Chloroform) | Not detected | NMT 50ppm v/v |
| 20 | Sum of impurities other than ethanol and 2-methylbut-2-ene | 0.002% | NMT 0.1% v/v |
| 21 | Residue on evaporation | 8ppm | NMT 20ppm |
| 22 | Water | 0.0090% | NMT 0.02% m/m |
| 23 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
| 24 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
| 25 | E.coli | Absent/gm | should be absent/gm |
| 26 | Bacterial endotoxins | Less than 0.1 EU/mg | NMT 0.1 EU/mg |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, 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.
