Glycerol Anhydrous, 1Ltr

anhidro, adecuado para uso como excipiente EMPROVE® exp Ph Eur,BP,JP,USP,E 422,FCC

Manufacturer: Merck

Catalog ID: 104093.1000

Stock: In Stock

 

Description

Catalogue Number 104093
Synonyms 1,2,3-Propanetriol, Trihydroxylpropane, Protol, Glycerin
Description Glycerol

Product Information

CAS number 56-81-5
EC number 200-289-5
Grade Ph Eur,BP,JP,USP,E 422,FCC
Hill Formula C₃H₈O₃
Chemical formula (HOCH₂)₂CHOH
Molar Mass 92.1 g/mol
HS Code 2905 45 00

Physicochemical Information

Boiling point 290 °C (1013 hPa) (descomposición)
Density 1.26 g/cm3 (20 °C)
Explosion limit 2.6 - 11.3 %(V)
flash point 199 °C
Ignition temperature 400 °C
Melting Point 18 - 20 °C
pH value 5 (100 g/l, H₂O, 20 °C)
Vapor pressure <0.001 hPa (20 °C)

Toxicological Information

LD 50 oral DL50 Rata 12600 mg/kg
LD 50 dermal DL50 Conejo > 18700 mg/kg

Storage and Shipping Information

Storage Store at +5°C to +30°C.

Specifications

Assay (alkalimetric, calculated on anhydrous substance) 99.0 - 100.5 %
Identity passes test
Acidity or alkalinity passes test
Color passes test
Appearance of solution passes test
Refractive index (n 20/D) 1.471 - 1.474
Density (d 20/20) ≥ 1.258
Density (d 25/25) ≥ 1.259
Chloride (Cl) ≤ 0.0010 %
Sulfate (SO₄) ≤ 0.0010 %
halogenated compounds (as Cl) ≤ 0.0030 %
Heavy metals (as Pb) ≤ 0.0005 %
As (Arsenic) ≤ 0.0001 %
Ca (Calcium) ≤ 0.0001 %
Calcium (JP) passes test
Cd (Cadmium) ≤ 0.0001 %
Hg (Mercury) ≤ 0.0001 %
NH₄ (Ammonium) passes test
Pb (Lead) ≤ 0.0001 %
1,2,4-Butantriol (GC) ≤ 0.2 %
3-Monochlorpropan-1,2-diol (3-MCPD) ≤ 0.1 ppm
Acetone ≤ 0.5 %
Other residual solvents (ICH Q3C) ...excluded by production process
Diethylene glycol and related Substances (impurity A) ≤ 0.1 %
Diethylene glycol and related Substances (any further impurity) ≤ 0.1 %
Diethylene glycol and related Substances (Sum of all impurities) ≤ 0.5 %
Diethylene glycol and ethylene glycol impurities (diethylene glycol) ≤ 0.10 %
Diethylene glycol and ethylene glycol impurities (ethylene glycol) ≤ 0.10 %
Acrolein, glucose and ammonium compounds passes test
Acrolein, glucose and other reducing substances passes test
Aldehydes ≤ 10 ppm
Fatty acids and esters (as Butyric acid) ≤ 0.05 %
Readily carbonizable substances passes test
Sugar passes test
Sulfated ash ≤ 0.01 %
Water ≤ 1.0 %
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to Ph Eur, BP, JP, USP, E 422, FCC. Conforms to the purity criteria on food additives according to the current European Commission Regulation. 3-Monochlorpropan-1,2-diol (3-MCPD) test performed by a qualified external laboratory.
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