COA-I3720LM500-40281B403CW

Product Name	Glycerin CDMF PARENTEX PLUS 500ML
SAP Code	I3720LM500	Batch No	40281B403CW
Grade	CDMF PARENTEX PLUS	IR No	40281B4
CASR No.	56-81-5	QC Ref. No	92938
Molecular Formula	C3H8O3	Manufacture Date	March 2023
Molecular Weight	92.10	Expiry Date	February 2026

Sr.No.	Test	Result	Specification
1	Description	Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. Is hygroscopic. Its solutions are neutral to litmus.	Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. Is hygroscopic. Its solutions are neutral to litmus.
2	Solubility	Complies	Miscible with water, ethanol (96%) and with alcohol. Slightly soluble in acetone. Insoluble in fatty oils, in essential oils, in chloroform, in ether and in fixed and volatile oils.
3	Identification (By IR)	Complies	IR spectra of the sample should be concomitant with IR spectra of the standard.
4	Identification (Diethylene glycol)	Not detected	NMT 0.10%
5	Identification (Ethylene glycol)	Not detected	NMT 0.10%
6	Identification (By GC Chromatogram)	Complies	The retention time of the glycerine peak of the Sample solution corresponds to that obtained in the Standard solution.
7	Identification 1 (By Chemical test)	Complies	Within 10 min, the blue colour does not diffuse into the lower layer.
8	Identification 2 (By Chemical test)	Complies	Vapours (acrolein) are evolved which blacken filter paper impregnated with alkaline potassium tetraiodomercurate solution.
9	Appearance of solution	Complies	Clear and colorless solution.
10	Color	Complies	The colour should not be darker than reference solution.
11	Acidity or alkalinity	Complies	Pink colour should produce after adding 0.2 mL of 0.1 mol/L sodium hydroxide solution.
12	Refractive index, 20°C	1.474	1.470 - 1.475
13	Relative density (20°C)	1.264	1.258 - 1.268
14	Aldehydes and reducing substances	Complies	The light absorption of the test solution at 655 nm should not be more than that of 2.0 mL of the reference solution.
15	Fatty acids and esters	Complies	NMT 2.0 mL of sodium hydroxide (0.1 mol/L) VS should require.
16	Related substances: Impurity A (Diethylene glycol)	Not detected	NMT 0.1%
17	Related substances: Any other impurity with a retention time less than the retention time of glycerol	0.01%	NMT 0.1%
18	Related substances: Total of all impurities with retention times greater than the retention time of glycerol	Not detected	NMT 0.5%
19	Related substances: Individual impurity	0.01%	NMT 0.1%
20	Related substances: Total impurities	0.01%	NMT 1.0%
21	Halogenated compounds	Less than 35 ppm	NMT 35 ppm
22	Sugars	Complies	The solution should remain blue and no precipitate should form.
23	Chlorides	Less than 0.0006%	NMT 0.0006%
24	Sulphate	Less than 0.002%	NMT 0.002%
25	Water	0.3%	NMT 2.0%
26	Residue on ignition	0.005%	NMT 0.01%
27	Assay (Anhydrous basis)	99.8%	99.0% - 101.0%
28	Chlorinated substances	Less than 0.003%	NMT 0.003%
29	Readily carbonizable substances	Complies	Any colour produced should not more intense than that of an equal volume of a reference solution.
30	Ammonium	Complies	No odour of ammonia should produced.
31	Calcium	Complies	The solution should be clear.
32	Iron	Less than 0.00005%	NMT 0.00005%
33	Total aerobic microbial count	Less than 100 CFU/gm	NMT 100 CFU/gm
34	Total combined yeast and mold count	Less than 10 CFU/gm	NMT 10 CFU/gm
35	Bacterial endotoxins	Less than 5 EU/gm	NMT 5 EU/gm
36	E.coli	Not detected	Should not be detected.

Remarks: THE CAPTIONED BATCH MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF THE ABOVE SPECIFICATION AS WELL AS USP, Ph.Eur, 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.