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Meglumine CDMF 500GM
93884SG50033491D210LT
CDMF33491D2
6284-40-875840
C7H17NO5December 2020
195.2November 2023
Sr.No.TestResultSpecification
1Appearance/DescriptionWhite, odorless crystalline powder.White to faintly yellowish –white, odorless crystalline powder.(USP/Ph.Eur./CP)
2SolubilityPassesFreely soluble in water, sparingly soluble in alcohol. Practically insoluble in dichloromethane and in trichloromethane. (USP/Ph.Eur./CP)
3Identification (By chemical test 1)CompliesThe mixture turns bright yellow and becomes clear. (USP)
4Identification (By chemical test 2)CompliesSilver mirror should form. (CP)
5Identification (By chemical test 3)CompliesInitial brown-red precipitate appears, and then it is dissolved into a brown-red solution. (CP)
6Identification (By chemical test 4)CompliesYellow green precipitate should form. (CP)
7Identification (By IR)CompliesThe IR absorption spectra of a substance should concomitant with the corresponding standard. (Ph.Eur)
8Appearance of solution0.006The solution is clear and its absorbance should be NMT 0.030. (USP/Ph.Eur/CP)
9Melting range129.0°C to 131.3°CBetween 128°C to 132°C (USP/Ph.Eur)
10Specific Rotation /Optical rotation-16.4°Between -15.7° to -17.3°. (USP)
11Specific Rotation /Optical rotation (Dried substance)-16.4Between -16.0Ôü░ to -17.0Ôü░ (Ph.Eur)
12Loss on drying0.19%NMT 0.5 % w/w (USP/Ph.Eur./CP)
13Residue on ignition /Sulfated ash0.07%NMT 0.1 % w/w . (USP/Ph.Eur./CP)
14Absence of reducing substancesPassesThe colour of the solution does not change. (USP)
15Reducing substancesLess than 0.2%NMT 0.2% w/w as glucose. (Ph.Eur/CP)
16Assay99.5%99.0 % to 100.5 % w/w on dried basis. (USP/Ph.Eur.)
17Chloride (Cl)Less than 100 ppmNMT 100 ppm. (Ph.Eur)
18SulphateLess than 150 ppmNMT 150 ppm. (Ph.Eur)
19Aluminium (Al)0.21 ppmNMT 5 ppm. (Ph.Eur)
20Iron0.16 ppmNMT 10 ppm. (Ph.Eur)
21Nickel (Ni)0.06 ppmNMT 5 ppm. (Ph.Eur/CP)
22Related substances: Single impurity0.038%NMT 0.25%. (CP)
23Related substances: Total impurity0.075%NMT 0.5%. (CP)
24Residual Solvents (Methanol)244ppmNMT 3000 ppm. (In-house)
25Total aerobic microbial countLess than 100 CFU / gNMT 100 CFU /g (In-house)
26Total combined yeast and molds countLess than 10 CFU / gNMT 10 CFU / g (In-house)
27Bacterial endotoxinsLess than 1.5 IU / gNMT 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 AND CP 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.
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