| Meglumine CDMF PARENTEX 500GM | |||
| P3884SG500 | 37093C301CV | ||
| CDMF PARENTEX | 37093C3 | ||
| 6284-40-8 | 83285 | ||
| 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.(USP/Ph.Eur./CP) |
| 2 | Solubility | Passes | Freely soluble in water, sparingly soluble in alcohol. Practically insoluble in dichloromethane and in trichloromethane. (USP/Ph.Eur./CP) |
| 3 | Identification (By chemical test 1) | Complies | The mixture turns bright yellow and becomes clear. (USP) |
| 4 | Identification (By chemical test 2) | Complies | Silver mirror should form. (CP) |
| 5 | Identification (By chemical test 3) | Complies | Initial brown-red precipitate appears, and then it is dissolved into a brown-red solution. (CP) |
| 6 | Identification (By chemical test 4) | Complies | Yellow green precipitate should form. (CP) |
| 7 | Identification (By IR) | Complies | The IR absorption spectra of a substance should concomitant with the corresponding standard. (Ph.Eur) |
| 8 | Appearance of solution | 0.024 | The solution is clear and its absorbance should be NMT 0.030. (USP/Ph.Eur/CP) |
| 9 | Melting range | 129°C to 130°C | Between 128°C to 132°C (USP/Ph.Eur) |
| 10 | Specific Rotation /Optical rotation | -16.3° | Between -15.7° to -17.3°. (USP) |
| 11 | Specific Rotation /Optical rotation (Dried substance) | -16.3° | Between -16.0Ôü░ to -17.0Ôü░ (Ph.Eur) |
| 12 | Loss on drying | 0.1% | NMT 0.5 % w/w (USP/Ph.Eur./CP) |
| 13 | Residue on ignition /Sulfated ash | 0.06% | NMT 0.1 % w/w . (USP/Ph.Eur./CP) |
| 14 | Absence of reducing substances | Passes | The colour of the solution does not change. (USP) |
| 15 | Reducing substances | Less than 0.2% | NMT 0.2% w/w as glucose. (Ph.Eur/CP) |
| 16 | Assay | 99.8% | 99.0 % to 100.5 % w/w on dried basis. (USP/Ph.Eur.) |
| 17 | Chloride (Cl) | Less than 100 ppm | NMT 100 ppm. (Ph.Eur) |
| 18 | Sulphate | Less than 150 ppm | NMT 150 ppm. (Ph.Eur) |
| 19 | Aluminium (Al) | 0.58 ppm | NMT 5 ppm. (Ph.Eur) |
| 20 | Iron | 1.03 ppm | NMT 10 ppm. (Ph.Eur) |
| 21 | Nickel (Ni) | 0.25 ppm | NMT 5 ppm. (Ph.Eur/CP) |
| 22 | Related substances: Single impurity | Not detected | NMT 0.25%. (CP) |
| 23 | Related substances: Total impurity | Not detected | NMT 0.5%. (CP) |
| 24 | Residual Solvents (Methanol) | Less than 3000 ppm | NMT 3000 ppm. (In-house) |
| 25 | Total aerobic microbial count | Less than 100 CFU/g | NMT 100 CFU /g (In-house) |
| 26 | Total combined yeast and molds count | Less than 10 CFU/g | NMT 10 CFU / g (In-house) |
| 27 | Bacterial endotoxins | Less than 1.5 IU/g | NMT 1.5 IU / g (In-house) |
Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, BP AND Ch.P 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.
