Glycerin may also be used orally in doses of 1.0-1.5 g/kg
`body-weight to reduce intraocular pressure.
`When used as an excipient or food additive, glycerin is not
`usually associated with any adverse effects and is generally
`regarded as a nontoxic and nonirritant material.
`
`LDso (guinea pig, oral}: 7.75 g/kg(S)
`LD50 (mouse, IP}: 8.98 g/kg
`LD 5o (mouse, IV}: 4.25 g/kg
`LD50 (mouse, oral}: 4.1 g/kg
`LD50 (mouse, SC}: 0.09 g/kg
`LD50 (rabbit, IV}: 0.05 g/kg
`LD5o (rat, IP}: 4.42 g/kg
`LD5o (rat, oral}: 12.6 g/kg
`LD5o (rat, SC}: 0.lg/kg
`
`1 S Handling Precautions
`Observe normal precautions appropriate to the circumstances
`and quantity of material handled. Eye protection and gloves
`are recommended. In the UK, the recommended long-term (8-
`9
`hour TWA) exposure limit for glycerin mist is 10mg/m 3
`)
`.(
`Glycerin is combustible and may react explosively with strong
`oxidizing agents; see Section 12.
`
`16 Regulatory Status
`GRAS listed. Accepted as a food additive in Europe. Included
`in the FDA Inactive Ingredients Guide (inhalations; injections;
`nasal and ophthalmic preparations; oral capsules, solutions,
`suspensions and tablets; otic, rectal, topical, transdermal, and
`vaginal preparations). Included in nonparenteral and parent(cid:173)
`eral medicines licensed in the UK.
`
`17 Related Substances
`
`Glycerin
`
`259
`
`19 Specific References
`1 Spiegel AJ, Noseworthy MM. Use of nonaqueous solvents in
`parenteral products. J Pharm Sci 1963; 52: 917-927.
`2 Kumar V, Kang J, Yang T. Preparation and characterization of
`spray-dried oxidized cellulose particles. Pharm Dev Technol 2001;
`6(3) : 449-458.
`3 Palviainen P, Heinamaki J, Myllarinen P, et al. Corn starches as
`film formers in aqueous-based film coating. Pharin Dev Technol
`2001; 6(3): 353-361.
`4 Viegas TX, Van-Winkle LL, Lehman PA, et al. Evaluation of
`creams and ointments as suitable formulations for peldesine. Int J
`Pharm 2001; 219(1-2): 73-80.
`5 Sweetman SC, ed. Martindale: The Complete Drug Reference,
`33rd edn. London: Pharmaceutical Press, 2002: 1616-1617.
`6 Hagnevik K, Gordon E, Lins LE, et al. Glycerol-induced
`haemolysis with haemoglobinuria and acute renal failure. Lancet
`1974; i: 75-77.
`7 Welch KMA, Meyer JS, Okamoto S, et al. Glycerol-induced
`haemolysis. Report of three cases. [letter]. Lancet 1974; 1(7847):
`416-417.
`8 8, Lewis RJ, ed . Sax's Dangerous Properties of Industrial
`ew York: Wiley, 2000: 1874-1875.
`Materials, 10th edn.
`9 Health and Safety Executive. EH40/2002: Occupational Exposure
`Limits 2002. Sudbury: Health and Safety Executive, 2002.
`
`20 General References
`Grissom CB, Chagovetz AM, Wang Z. Use of viscosigens to stabilize
`vitamin B12 solutions against photolysis. J Pharm Sci 1993; 82(6):
`641--643.
`Jungermann E, Sonntag NOV, eds. Glycerine: A Key Cosmetic
`Ingredient. New York: Marcel Dekker, 1991.
`Srnolinske SC. Handbook of Food, Drug, and Cosmetic Excipients.
`Boca Raton, FL: CRC Press, 1992: 199-204.
`Staples R, Misher A, Wardell J. Gastrointestinal irritant effect of
`glycerin as compared with sorbitol and propylene glycol in rats
`and dogs. J Pharm Sci 1967; 56: 398-400.
`
`18 Comments
`The EINECS number for glycerin is 200-289-5.
`Some pharmacopeias also contain specifications for diluted
`glycerin solutions. The JP 2001 contains a monograph for
`that contains 84-87% of propane-1,2,3-triol
`'glycerin'
`(C3Hs03). The PhEur 2002 contains a monograph for
`'glycerol 85 per cent' that contains 83.5--88.5% of propane-
`1,2,3-triol (C3Hs03).
`
`21 Author
`JC Price.
`
`22 Date of Revision
`8 October 2002.
`
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