Glycerol for Injection

Category

Solvent; Suspending Agents

Molecular Formula

C3H8O3

Molecular Weight

92.09

Grade

Pharmceutical Excipients

UNII

PDC6A3C0OX

Chemical Name

1, 2, 3-Propanetriol; Propane-1, 2, 3-triol

CAS Number

56-81-5

Synonyms

Glycerin(USP); Concentrated Glycerin(JP); glycerolum(PhEur)

Administration route

Absorbent; Injection; Nasal and ocular; Oral; Ear, rectum, local, transdermal, vaginal

Dosage Form

Absorbent; Injection; Nasal and ocular preparations; Oral capsules; A solution; Suspension agent; Tablets; Ear, rectum, local, transdermal, vaginal administration preparations

Stability and Storage Conditions

Glycerin is hygroscopic. Under normal storage conditions, pure glycerol is not easily oxidized by air, but when heated, it degrades and generates toxic acrolein. Glycerol is chemically stable with the mixture of water, ethanol and propylene glycol. Glycerol may crystallize if stored at low temperature, and the crystals will not melt until above 20℃. Glycerin should be stored in a cool, dry place in an airtight container.

Source and Preparation

Glycerol is mainly produced from oils and fats as a by-product in the production of soap and fatty acids, or from natural products such as beetroot molasses fermented in the presence of large quantities of sodium sulfite. In terms of chemical synthesis, propylene can be prepared by chlorination and saponification.

Applications

Glycerol is mainly used as solvent and suspending agent in injectable preparations.

Safety

Glycerol is found naturally in animal and vegetable fats and oils and can be digested as part of regular food. Glycerol is easily absorbed by the small intestine and metabolized as carbon dioxide, liver sugar, or synthetic body fat. Glycerin is widely used in oral, ophthalmic, topical and injectable preparations, and the adverse reactions mainly come from the dewatering of glycerin. No toxicity was observed after delayed administration. LD50 (mouse, IP): 8.98 g/kg LD50 (mouse, IV): 4.25 g/kg LD50 (mouse, SC): 0.09 g/kg LD50 (rabbit, IV): 0.05 g/kg LD50 (rat, IP): 4.42 g/kg LD50 (rat, SC): 0.1 g/kg Maximum dosage of intravenous injection 22.50%; The maximum dosage of intramuscular injection is 15.36%; The maximum dosage of subcutaneous injection was 32.50%.

Incompatibilities

Glycerin may explode if mixed with strong oxidants (e.g., chromium trioxide, potassium chlorate, potassium permanganate, etc.). The reaction rate is low in dilute solution, and several oxidation products are generated. Glycerol turns black when exposed to light or contact with basic bismuth nitrate and zinc oxide. Mixtures containing phenol, salicylic acid, and danic acid can be blackened if iron contaminants are involved. Glycerol forms a boric acid complex (glyceroborate), which is more acidic than boric acid.