| Meglumine USP/Ph.Eur/BP PARENTEX 5KG | |||
| P1884SR500 | 37231B215CV | ||
| USP/Ph.Eur/BP PARENTEX | 37231B2 | ||
| 6284-40-8 | 85070 | ||
| C7H17NO5 | March 2022 | ||
| 195.2 | February 2024 | ||
| 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, sparingly soluble in ethanol (96 %). 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 | 0.026 | The solution is clear and its absorbance should not be more than 0.030. |
| 6 | Melting range | 129°C to 130°C | Between 128°C to 132°C. |
| 7 | Specific rotation | -16.5° | Between -15.7° to -17.3°. |
| 8 | Specific optical rotation (Dried substance) | -16.5° | Between -16.0 to -17.0. |
| 9 | Loss on drying | 0.2% | NMT 0.5 %. |
| 10 | Residue on ignition /Sulfated ash | 0.05% | NMT 0.1 % . |
| 11 | Absence of reducing substances | Passes | The colour of the solution does not change. |
| 12 | Reducing substances | Less than 0.2% | NMT 0.2% as glucose. |
| 13 | Assay | 99.8% | 99.0 % - 100.5 % of C7H17NO5 on dried basis. |
| 14 | chloride | Less than 100 ppm | NMT 100 ppm. |
| 15 | Sulphate | Less than 150 ppm | NMT 150 ppm. |
| 16 | Aluminium (Al) | 0.80 ppm | NMT 5 ppm. |
| 17 | Iron | Less than 10 ppm | NMT 10 ppm. |
| 18 | Nickel (Ni) | 3.12 ppm | NMT 5 ppm. |
| 19 | Residual Solvents (Methanol) | 332 ppm | NMT 3000 ppm. |
| 20 | Total aerobic microbial count | Less than 1000 CFU/gm | NMT 1000 CFU /gm |
| 21 | Total combined yeast and molds count | Less than 100 CFU/gm | NMT 100 CFU/ gm |
| 22 | Bacterial endotoxins | Less than 1.5 IU/gm | NMT 1.5 IU / 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.
