| Methylene chloride Excipient Grade 2.5LT | |||
| 80550LC250 | 523771730DO | ||
| Excipient Grade | 5237717 | ||
| 75-09-2 | 20494 | ||
| ClCH2Cl | April 2015 | ||
| 84.93 | March 2018 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Description | Clear colourless,volatile liquid. | Clear colourless,Volatile liquid,having an odour resembling to that of Chloroform. |
| 2 | Solubility | Passes | Sparingly soluble in water, Miscible with ethanol (96%),with ether and with fixed and volatile oils. |
| 3 | Appearance of solution | Complies | It is Clear & Colourless. |
| 4 | Identification by IR | Complies | To comply the test |
| 5 | Identification A,B, C, D, & E | Complies | To comply the test. |
| 6 | Relative density,20°C | 1.324 | 1.320 - 1.332 |
| 7 | Specific gravity, 25°C | 1.319 | 1.318 - 1.322 |
| 8 | Refractive index, 20°C ± 0.5°C | 1.423 | 1.423 - 1.425 |
| 9 | Residue on evaporation | 0.0005% | 0.0020% max. |
| 10 | Limit of hydrogen chloride | NMT 0.001% | 0.001% max. |
| 11 | Acidity(as HCl) | Passes | NMT 0.15ml of 0.1M sodium hydroxide is required. |
| 12 | Free Chlorine(Cl) | Complies | To comply the test. |
| 13 | Iodine test | Complies | To comply the test |
| 14 | Heavy metals | NMT 0.0001% | 0.0001% max. |
| 15 | Impurity A | Not detected | NMT 4 ppm V/V (Carbon tetra chloride) |
| 16 | Impurity B | NMT 50ppm | NMT 50 ppm V/V (Chloroform) |
| 17 | Ethanol(C2H5OH) | Not detected | NMT 2.0% max. m/m |
| 18 | 2-methylbut-2-ene | NMT 0.03% | NMT 0.03% V/V (Stabilizer) |
| 19 | Total impurity other than Ethanol & 2-methylbut-2-ene | NMT 0.1% | NMT 0.1% V/V |
| 20 | Water | 0.0078% | 0.02% max. m/m |
| 21 | Assay (GC) (with stabilizer) | 99.96% | Min. 99.50% |
| 22 | Residual solvent (ICH) | Complies | To comply the test |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, 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.
