Acetyltributyl citrate should be stored in a well-closed container in a cool, dry location at temperatures not exceeding 388C. When stored in accordance with these conditions, acetyltributyl citrate is a stable product. 12 6

Acesulfame potassium possesses good stability. In the bulk form it shows no sign of decomposition at ambient temperature over many years. In aqueous solutions (pH 3.0–3.5 at 208C) no reduction in sweetness was observed over a period of approximately 2 years. Stability at elevated temperatures is good, although some decomposition was noted following storage at 408C for several months. Sterilization and pasteurization do not affect the taste of acesulfame potassium.(5) The bulk material should be stored in a well-closed container in a cool, dry place. 12 Paul J. Sheskey - Principal Research Scientist (retired), The Dow Chemical Company, Midland, MI, USA; Identification Characters Appearance of solution Acidity or alkalinity Relative density Related substances Matter insoluble in water Reducing substances Residue on evaporation Water Assay Steurnagel CR. Latex emulsions for controlled drug delivery. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, 1989: 1–61. 4 Gutierrez-Rocca JC, McGinity JW. Influence of aging on the physical-mechanical properties of acrylic resin films cast from aqueous dispersions and organic solutions. Drug Dev Ind Pharm 1993; 19(3): 315–332. 5 Repka MA, Gerding TG, Repka SL. Influence of plasticisers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion. Drug Dev Ind Pharm 1999; 25(5): 625–633. 6 Lieb S, Szeimies RM, Lee G. Self-adhesive thin films for topical delivery of 5-aminolevulinic acid. Eur J Pharm Biopharm 2002; 53(1): 99–106. 7 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 3512. 8 Goulas AE, Riganakos KA, Ehlermann DA, et al. Effect of highdose electron beam irradiation on the migration of DOA and ATBC plasticizers from food-grade PVC and PVDC/PVC films, respectively, into olive oil. J Food Prot 1998; 61(6): 720–724. 9 Dorfer CE, Kim TS, Steinbrenner H, et al. Regenerative periodontal surgery in interproximal intrabony defects with biodegradable barriers. J Clin Peridontol 2000; 27(3): 162–168.

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millimeter of mercury (mmHg) = 133.322 pascals (Pa) 1 pound per square inch (psi) = 6894.76 pascals (Pa) Surface tension 1 dyne per centimeter (dyne/cm) = 1 millinewton per meter (mN/m) Temperature Celsius (8C) = (1.8  8C) þ 32 Fahrenheit (8F) Fahrenheit (8F) = (0.556  8F) –17.8 Celsius (8C) Viscosity (dynamic) 1 centipoise (cP) = 1 millipascal second (mPa s) 1 poise (P) = 0.1 pascal second (Pa s) Acetic acid; artificial vinegar; dilute acetic acid. Acetic acid Comments: a diluted solution of glacial acetic acid containing 30–37% w/w of acetic acid. See Section 18. Artificial vinegar Comments: a solution containing 4% w/w of acetic acid. Characters Identification Appearance of solution Acidity or alkalinity Acetylacetamide Impurity B and related substances Fluorides Heavy metals Loss on drying Assay

Observe normal precautions appropriate to the circumstances and quantity of material handled. Acetyltributyl citrate is A specification for acetone is included in the Japanese Pharmaceutical Excipients (JPE).(7) The EINECS number for acetone is 200-662-2.Acetyltributyl citrate is prepared by the esterification of citric acid with butanol followed by acylation with acetic anhydride. Gutierrez-Rocca JC, McGinity JW. Influence of water soluble and insoluble plasticizer on the physical and mechanical properties of acrylic resin copolymers. Int J Pharm 1994; 103: 293–301. 2 Lehmann K. Chemistry and application properties of polymethacrylate coating systems. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, 1989: 153–245. Solubility: soluble in boiling water to form a viscous solution; practically insoluble in ethanol (95%), and cold water. A 1% w/v aqueous solution forms a stiff jelly on cooling. Anderson DMW, Dea ICM. Recent advances in the chemistry of acacia gums. J Soc Cosmet Chem 1971; 22: 61–76. Anderson DM, Douglas DM, Morrison NA, Wang WP. Specifications for gum arabic (Acacia Senegal): analytical data for samples collected between 1904 and 1989. Food Add Contam 1990; 7: 303–321. Aspinal GO. Gums and mucilages. Adv Carbohydr Chem Biochem 1969; 24: 333–379. Whistler RL. Industrial Gums. New York: Academic Press, 1959. Sweetman SC, ed. Martindale: The Complete Drug Reference, 34th edn. London: Pharmaceutical Press, 2005: 1645. 2 Fenner PJ, Williamson JA. Worldwide deaths and severe envenomation from jellyfish stings. Med J Aust 1996; 165: 658–661. 3 Milner SM. Acetic acid to treat Pseudomonas aeruginosa in superficial wounds and burns. Lancet 1992; 340: 61. 4 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 15–16. 5 Health and Safety Executive. EH40/2002: Occupational Exposure Limits 2002, Sudbury: Health and Safety Executive, 2002.

Acidity/alkalinity: pH = 4.5–5.0 (5% w/v aqueous solution) Acid value: 2.5 Hygroscopicity: at relative humidities of 25–65%, the equilibrium moisture content of powdered acacia at 258C is 8–13% w/w, but at relative humidities above about 70% it absorbs substantial amounts of water. Solubility: soluble 1 in 20 of glycerin, 1 in 20 of propylene glycol, 1 in 2.7 of water; practically insoluble in ethanol (95%). In water, acacia dissolves very slowly, although almost completely after two hours, in twice the mass of water leaving only a very small residue of powder. The solution is colorless or yellowish, viscous, adhesive, and translucent. Spray-dried acacia dissolves more rapidly, in about 20 minutes. Specific gravity: 1.35–1.49 Viscosity (dynamic): 100 mPa s (100 cP) for a 30% w/v aqueous solution at 208C. The viscosity of aqueous acacia solutions varies depending upon the source of the material, processing, Steurnagel CR. Latex emulsions for controlled drug delivery. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, 1989: 1–61. 5 Gutierrez-Rocca JC, McGinity JW. Influence of aging on the physical-mechanical properties of acrylic resin films cast from aqueous dispersions and organic solutions. Drug Dev Ind Pharm 1993; 19(3): 315–332. 6 Siepmann J, Lecomte F, Bodmeier R. Diffusion-controlled drug delivery systems: calculation of the required composition to achieve desired release profiles. J Control Release 1999; 60(2–3): 379–389. 7 Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 58–59. Acetyltriethyl citrate is prepared by the esterification of citric acid with ethanol followed by acylation with acetic anhydride. 14 GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (oral tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 17 JT Stewart University of Georgia Athens, GA, USA Y Sun University of Tennessee Memphis, TN, USA AK Taylor Baton Rouge, LA, USA MS Tesconi Wyeth Research Pearl River, NY, USA

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Agar-agar; Bengal isinglass; Ceylon isinglass; Chinese isinglass; E406; gelosa; gelose; Japan agar; Japan isinglass; layor carang. 3 The Handbook of Pharmaceutical Excipients is internationally recognized as the world’s most authoritative source of information on pharmaceutical excipients. It is the definitive comprehensive guide to uses, properties and safety of excipients providing scientists and researchers with a one stop resource when researching an excipient. Acidity/alkalinity: pH = 6.7–7.3 for a 1% w/v solution, in 0.9% w/v sodium chloride solution, at 208C. Observe normal precautions appropriate to the circumstances and quantity of material handled. Acetone is a skin and eye irritant (see Section 14), therefore gloves, eye protection and a respirator are recommended. In the UK, the long-term (8-hour TWA) exposure limit for acetone is 1210 mg/m3 (500 ppm). The short-term (15-minute) exposure limit is 3620 mg/m3 (1500 ppm).(6) 16