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

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