| Meglumine CPH4 5KG | |||
| 10884SR500 | 364734916LU | ||
| Customised pharma grade 4 | 3647349 | ||
| 6284-40-8 | 80978 | ||
| C7H17NO5 | December 2021 | ||
| 195.2 | November 2023 | ||
| Sr.No. | Test | Result | Specification |
|---|---|---|---|
| 1 | Appearance/Description | White, odorless crystalline powder. | White to faintly yellowish –white, odorless crystalline powder. |
| 2 | Solubility | Passes | Freely soluble in water, slightly soluble in alcohol. Practically insoluble in dichloromethane. |
| 3 | Identification (By Chemical test) | Complies | The mixture turns bright yellow and becomes clear. |
| 4 | Identification (By IR) | Complies | The IR absorption spectra of a substance should concomitant with the corresponding standard. |
| 5 | Completeness and color of solution / Appearance of solution | 0.017 | The solution is clear and its absorbance should not be more than 0.030. |
| 6 | Melting range | 128°C to 131°C | Between 128°C to 132°C. |
| 7 | Specific rotation | -16.9° | Between -16.0° to -17.3°. |
| 8 | Specific optical rotation (Dried substance) | -16.9 | Between -16.0 to -17.0. |
| 9 | Loss on drying | 0.4% | Not more than 0.5 %. |
| 10 | Residue on ignition /Sulfated ash | 0.05% | Not more than 0.1 % . |
| 11 | Absence of reducing substances | Passes | The colour of the solution does not change. |
| 12 | Reducing substances | Less than 0.2% | 0.2% max. as glucose. |
| 13 | Assay | 99.8% | 99.0 % - 100.5 % of C7H17NO5 on dried basis. |
| 14 | chloride | Less than 100 ppm | Not more than 100 ppm. |
| 15 | Sulphate | Less than 150 ppm | Not more than 150 ppm. |
| 16 | Aluminium (Al) | 1.8 ppm | Not more than 5 ppm. |
| 17 | Iron | 7.7 ppm | Not more than 10 ppm. |
| 18 | Nickel (Ni) | 1.2 ppm | Not more than 5 ppm. |
| 19 | Residual Solvents (Methanol) | 545 ppm | Not more than 3000 ppm. |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur AND 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.
