Meglumine USP/Ph.Eur/BP PARENTEX 5KG Go Back


: 6284-40-8

Molecular Formula

: C7H17NO5

Molecular Weight

: 195.2
Appearance/Description: White to faintly yellowish –white, odorless crystalline powder.
Solubility: Freely soluble in water, Practically insoluble in dichloromethane.
Identification (By Chemical test): The mixture turns bright yellow and becomes clear.
Identification (By IR): The IR absorption spectra of a substance should concomitant with the corresponding standard.
Completeness and color of solution / Appearance of solution: The solution is clear and its absorbance should not be more than 0.030.
Melting range: Between 128°C to 132°C
Specific rotation: Between -15.7° to -17.3°
Specific optical rotation (Dried substance): Between -16.0 to -17.0
Loss on drying: NMT 0.5 %.
Residue on ignition /Sulfated ash: NMT 0.1 %
Absence of reducing substances: The colour of the solution does not change
Reducing substances: NMT 0.2% as glucose
Assay: 99.0 % - 100.5 % of C7H17NO5 on dried basis
chloride: NMT 100 ppm
Sulphate: NMT 150 ppm
Aluminium (Al): NMT 5 ppm
Iron: NMT 10 ppm
Nickel (Ni): NMT 5 ppm
Residual Solvents (Methanol): NMT 3000 ppm
Total aerobic microbial count: NMT 100 CFU/gm
Total Yeast and mold count: NMT 10 CFU/gm
Bacterial endotoxins: NMT 1.5 IU/gm
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