| Meglumine CPH4 PARENTEX 5KG | |||
| P0884SR500 | 35593G528HU | ||
| CPH4 PARENTEX | 35593G5 | ||
| 6284-40-8 | 80003 | ||
| C7H17NO5 | August 2021 | ||
| 195.2 | July 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, 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 | 0.006 | The solution is clear and its absorbance should not be more than 0.030. |
| 6 | Melting range | 128°C to 130°C | Between 128°C to 132°C. |
| 7 | Specific rotation | -16.1° | Between -15.7° to -17.3°. |
| 8 | Specific optical rotation (Dried substance) | -16.4° | Between -16.0 to -17.0. |
| 9 | Loss on drying | 0.3% | NMT 0.5 %. |
| 10 | Residue on ignition /Sulfated ash | 0.04% | 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) | 0.81 ppm | NMT 5 ppm. |
| 17 | Iron | Less than 10 ppm | NMT 10 ppm. |
| 18 | Nickel (Ni) | 0.14 ppm | NMT 5 ppm. |
| 19 | Residual Solvents (Methanol) | 66 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, 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.
