Glycerol-Synthetic
USP,EP/BP, JP, Injectable Grade
CAS #:
56-81-5
Molecular Formula:
C3H8O3
Synonym:
1,2,3-Propanetriol, Glycerin
Molecular Weight:
92.09 g/mol
Overview
Glycerol is a sugar alcohol (polyol) compound. An odourless, viscous and colourless liquid that has three hydroxyl groups that allow its solubility in water and give it it's hygroscopic nature. Used in the personal care and pharmaceutical industry for improving smoothness and lubrication it is also used as a solvent and preservative.Glycerol, Natural, USP, EP, BP is produced from the hydrolysis of animal or vegetable lipids during soap manufacture but the majority of natural glycerin now comes as a result of it being a side product during the production of biodiesel.It is used in food and beverage, and personal care ingredients with the primary usages in sugar substitutes, moisturizing agent for baked goods and as a thickener in ear drops, toothpaste and jellies.
| Characters | Unit | Specification |
|---|---|---|
| Identity | ||
| Identification A 1,2 | Passes Test | |
| Identification B 2 | Passes Test | |
| Identification B (Diethylene Glycol) 1 | % | ≤ 0.10 |
| Identification B (Ethylene Glycol) 1 | % | ≤ 0.10 |
| Identification C 1,2 | Passes Test | |
| Identification D 2 | Passes Test | |
| Appearance 1,2 | Clear, colorless, viscous liquid | |
| Appearance of Solution 2 | Passes Test | |
| Solubility 1,2 | Passes Test | |
| Assay (LISP) 1,2 | % | ≥ 99.0 – 101.0 |
| Impurity A 1,2& related substances | % | ≤ 0.1 |
| Any other Impurities 1,2 | % | ≤ 0.1 |
| Total impurities 1,2 | % | ≤ 0.5 |
| Specific Gravity (25°C) 1 | ≥ 1.249 | |
| Color (APHA) 1 | ≤ 10 | |
| Acidity or Alkalinity 2 | Passes Test | |
| Residue on Ignition 1 | % | ≤ 0.01 |
| Ash (sulfated) 2 | % | ≤ 0.01 |
| Water (H2O) 1,2 | % | ≤ 2.0 |
| Fatty Acid Esters (0.5N NaOH) 1 | ml | ≤ 0.3 |
| Esters2 | Passes Test | |
| Refractive Index 2 | 1.470 - 1.475 | |
| Aldehydes 2 | ppm | ≤ 10 |
| Halogenated Compounds 2 | ppm | ≤ 35 |
| Sugars 2 | Passes Test | |
| Chlorinated Compounds 1 | ppm | ≤ 30 |
| Chloride (Cl) 1,2 | ppm | ≤ 10 |
| Sulfate (SO4) 1,2 | ppm | ≤ 20 |
| Elemental Impurities | Conforms to USP<232><233> parenteral application | |
| Residual solvents | Meets the requirement | |
| Endotoxin (USP <85>) | EU/g | < 1 |
| Total Plate Count (USP <61>) | CFU/g | < 100 |
| Mold& Yeast Count (USP <61>) | CFU/g | < 100 |
| E. Coli | ND | |
| 1 = USP; 2 = EP/BP; 3 = JP | ||
Shelf Life/Retest Date: The shelf-life for USP, EP, Glycerin/Glycerol is 3 years when the product is stored at 25°C.
Storage/Shipping Conditions:
- Keep container tightly closed in a dry and well-ventilated place.
- There is no need for refrigeration during air transportation.
Pack Sizes: 5 Kg
