| Methylene chloride USP-NF/Ph.Eur/BP PARENTEX PLUS 2.5LT | |||
| I0550LC250 | 39266C116KV | ||
| USP-NF/Ph.Eur/BP PARENTEX PLUS | 39266C1 | ||
| 75-09-2 | 89851 | ||
| ClCH2Cl | November 2022 | ||
| 84.93 | October 2025 | ||
| 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 ( By Relative density, 20°C) | 1.321 | 1.320 to 1.332 |
| 4 | Identification B (By 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 | 1.321 | 1.320 to 1.332 |
| 10 | Specific gravity, 25°C | 1.319 | 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 | Not detected | NMT 2.0% |
| 17 | 2-methylbut-2-ene | 49 ppm | NMT 300 ppm |
| 18 | Impurity A (Carbon tetrachloride) | Not detected | NMT 10 ppm |
| 19 | Impurity B (Chloroform) | Not detected | NMT 50 ppm |
| 20 | Sum of impurities other than ethanol and 2-methylbut-2-ene | 0.001% | NMT 0.1% |
| 21 | Residue on evaporation | 10 ppm | NMT 20 ppm |
| 22 | Water | 0.004% | NMT 0.02% |
| 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 10CFU/gm |
| 25 | Bacterial endotoxins | Less than 0.1 EU/mg | NMT 0.1EU/mg |
| 26 | E.coli | Absent/gm | should be absent/gm |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP-NF, Ph.Eur, BP 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.
