Glycerol Anhydrous Pure 2.5ltr
anhidro, adecuado para uso como excipiente EMPROVE® exp Ph Eur,BP,JP,USP,E 422,FCC
Manufacturer: Merck
Catalog ID: 104093.2500
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
| DL 50 oral | DL50 Rata 12600 mg/kg |
| LD 50 dermal | LD50 Rabbit > 18700 mg/kg |
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. |
