| Appearance (USP) |
Clear, colourless syrupy liquid; hygroscopic |
| Appearance (EP, BP) |
Colourless or almost colourless, syrupy liquid; very hygroscopic |
| Appearance (JP) |
A clear colourless and viscous liquid; hygroscopic |
| Appearance (IP) |
A clear colourless or almost colourless, syrupy liquid; very hygroscopic |
| Solubility (USP) |
Insoluble in chloroform, in ether and in fixed and volatile oils. Miscible with water and with alcohol. |
| Solubility (EP, BP) |
Miscible with water and with ethanol (96%), slightly soluble in acetone, Practically insoluble in fatty oils in essential oil. |
| Solubility (JP) |
Miscible with water and with ethanol (99.5%) |
| Solubility (IP) |
Miscible with water and with ethanol (95%); slightly soluble in acetone; practically insoluble in ether and in fixed oils and volatile oils |
| Identification : FTIR (JP) |
Matches with the standard pattern |
| Identification A : FTIR (USP, IP) |
Matches with the standard pattern |
| Identification A : RI (EP, BP) |
1.4700 - 1.4750 |
| Identification B, System suitability : Resolution (GC) (USP) |
>= 1.5 between diethylene glycol & glycerin |
| Identification B : Diethylene glycol & ethylene glycol : GC (USP) |
<= 0.10% (each for diethylene glycol & ethylene glycol is found) |
| Identification B : FTIR (EP, BP) |
Matches with the standard pattern |
| Identification B (IP) |
A blue ring develops at the interface of the two liquids. Allow to stand for 10 min., the blue colour does not diffuse into the two layer |
| Identification C (USP) |
The retention time of the glycerin peak of the sample solution corresponds to that obtained in the standard solution |
| Identification C : Relative density (EP, BP) |
1.258 - 1.268 |
| Identification C (IP) |
Complies |
| Identification D : RI (IP) |
1.4700 - 1.4750 (at 20°C) |
| Appearance of solution (EP, BP, IP) |
20% Solution in water is colourless. |
| Acidity or alkalinity (EP, BP) |
<= 0.2 mL of 0.1M NaOH is required to change the colour of the indicator to pink |
| Acidity or alkalinity (JP) |
The solution in neutral |
| Acidity or alkalinity (IP) |
<= 0.2 mL of 0.1M NaOH is required to produce a pink colour |
| Residue of ignition (USP, JP) |
<= 0.01% |
| Ester (EP, BP) |
>= 8.0 mL of 0.1M HCl is required to change the colour of the indicator |
| Colour (USP, JP) |
Passes Test |
| Iron (IP) |
<= 0.0004% |
| Chloride (IP) |
<= 0.0025% |
| Chloride (USP, EP, BP, JP) |
<= 0.001% |
| Calcium (JP) |
The solution remains unchanged |
| Heavy metals (JP, IP) |
<= 0.0005% |
| Arsenic (JP) |
<= 0.0002% |
| Aldehyde (EP, BP) |
<= 0.001% |
| Sulphate (USP, JP) |
<= 0.002% |
| Sulphate (IP) |
<= 0.003% |
| Ammonium (JP) |
The gas evolved does not change moistened red litmus paper to blue |
| Acrolin, glucose or other reducing substances (JP) |
The colour of the solution does not change and no turbidity is produced |
| System suitability : Resolution 1 : GC (JP) |
>= 40 (between the peak of ethylene glycol and diethylene glycol) |
| System suitability : Resolution 2 : GC (JP) |
>= 10 (between the peak of diethylene glycol and glycerin) |
| Ethylene glycol, diethylene glycol & related substances 1 (JP) |
<= 0.1% (the amount of the peaks other than the glycerin, ethylene glycol and diethylene glycol) |
| Ethylene glycol, diethylene glycol & related substances 2 (JP) |
<= 1.0% (the total amount of the peaks other than the glycerin) |
| Fatty acid & ester (JP) |
<= 3.0 mL of 0.1 mol/L NaOH is consumed |
| Suger (EP, BP, IP) |
The solution remains blue and no precipitate is formed. |
| Halogenated compound (EP, BP) |
<= 0.0035% |
| Readily carbonizable substances (JP) |
The solution has no more colour than matching fluid H |
| Aldehyde and reducing substances (IP) |
The test is not valid unless the standard solution is pink |
| Ethylene glycol, diethylene glycol and related substances : GC (IP) |
The area of any secondary peak in the chromatogram obotained with the test solution is less than the area of the peak corresponding to diethylene glycol in the chromatogram obtained with the reference solution |
| Ester (IP) |
>= 8.0 mL of 0.1M hydrochloric acid is required to decolourise the solution |
| Sulphated ash (EP, BP, IP) |
<= 0.01% |
| Related substance: System suitability : Resolution : GC (EP, BP) |
>= 7.0 between the peaks due to impurity A and glycerol |
| Related substance : Impurity A : GC (EP, BP) |
<= 0.1% |
| Related substance : Any other impurity : GC (EP, BP) |
<= 0.1% |
| Related substance: Total impurity : GC (EP, BP) |
<= 0.50% |
| Organic impurities 1: Related compound : System suitability: Resolution : GC (USP) |
>= 7.0 between diethylene glycol and glycerin |
| Organic impurities 2: Related compound : Individual impurity (USP) |
<= 0.1% |
| Organic impurities 3: Related compound : Total impurity: GC (USP) |
<= 1.0% |
| Organic impurities : Limit of chlorinated compound (USP) |
<= 0.003% of Cl |
| Organic impurities : Fatty acids and esters (USP) |
<= 1.0 mL of 0.5N NaOH is consumed |
| Specific gravity (USP) |
>= 1.249 |
| Specific gravity (JP) |
>= 1.258 |
| Refractive index (JP) |
>= 1.470 |
| Refractive index (EP, BP) |
1.4700 - 1.4750 |
| Water (K.F.) (USP) |
<= 5.0% |
| Water (K.F.) (EP, BP, JP, IP) |
<= 2.0% |
| Assay (NaOH T, anhydrous basis) (USP) |
99.00 - 101.00% |
| Assay (NaOH T, anhydrous basis) (EP, BP, JP, IP) |
98.00 - 101.00% |