Agar-agar; Bengal isinglass; Ceylon isinglass; Chinese isinglass; E406; gelosa; gelose; Japan agar; Japan isinglass; layor carang. 3 Acetone reacts violently with oxidizing agents, chlorinated solvents, and alkali mixtures. It reacts vigorously with sulfur dichloride, potassium t-butoxide, and hexachloromelamine. Acetone should not be used as a solvent for iodine, as it forms a volatile compound that is extremely irritating to the eyes.(4) 13 The information below shows imperial to SI unit conversions for the units of measurement most commonly used in the Handbook. SI units are used throughout with, where appropriate, imperial units reported in parentheses. Area 1 square inch (in2) = 6.4516  10–4 square meter (m2) 1 square foot (ft2) = 9.29030  10–2 square meter (m2) 1 square yard (yd2) = 8.36127  10–1 square meter (m2) Density 1 pound per cubic foot (lb/ft3) = 16.0185 kilograms per cubic meter (kg/m3) Energy 1 kilocalorie (kcal) = 4.1840  103 joules (J)

Albumin human (USP 28) Albumin human is a sterile nonpyrogenic preparation of serum albumin that is obtained by fractionating material (source blood, plasma, serum, or placentas) from healthy human donors. The source material is tested for the absence of hepatitis B surface antigen. It is made by a process that yields a product safe for intravenous use. Albumin solution, human (PhEur 2005) Human albumin solution is an aqueous solution of protein obtained from plasma. Separation of the albumin is carried out under controlled conditions so that the final product contains not less than 95% albumin. Human albumin solution is prepared as a concentrated solution containing 150–250 g/L of total protein or as an isotonic solution containing 35–50 g/L of total protein. A suitable stabilizer against the effects of heat such as sodium caprylate (sodium octanoate) or N-acetyltryptophan or a combination of these two at a suitable concentration, may be added, but no antimicrobial preservative is added at any stage during preparation Improve acceptability to patients, aid identification and prevent counterfeiting. Increase stability of light-sensitive drugs. Identification Specific gravity Refractive index Acidity Water Heavy metals Assay (anhydrous basis) E260; ethanoic acid; ethylic acid; methane carboxylic acid; vinegar acid. See also Sections 17 and 18.Acacia is used in cosmetics, foods, and oral and topical pharmaceutical formulations. Although it is generally regarded as an essentially nontoxic material, there have been a limited number of reports of hypersensitivity to acacia after inhalation or ingestion.(6,7) Severe anaphylactic reactions have occurred following the parenteral administration of acacia and it is now no longer used for this purpose.(6) The WHO has not set an acceptable daily intake for acacia as a food additive because the levels necessary to achieve a desired effect were not considered to represent a hazard to health.(8) LD50 (hamster, oral): >18 g/kg(9) LD50 (mouse, oral): >16 g/kg LD50 (rabbit, oral): 8.0 g/kg 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 K; E950; 6-methyl-3,4-dihydro-1,2,3-oxathiazin4(3H)-one 2,2-dioxide potassium salt; Sunett; Sweet One. 3 Jensen JL, Appel LE, Clair JH, Zentner GM. Variables that affect the mechanism of drug release from osmotic pumps coated with acrylate/methacrylate copolymer latexes. J Pharm Sci 1995; 84: 530–533. 2 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. 3 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. Internationally recognized as the world’s most authoritative source of information on pharmaceutical excipients. It provides you with a one stop resource when researching an excipient for use. 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

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Acid value: 0.02 Boiling point: 2948C (decomposes) Flash point: 1888C Pour point: 438C Solubility: soluble 1 in 140 of water; miscible with acetone, ethanol, and propan-2-ol. Viscosity (dynamic): 54 mPa s (54 cP) at 258C. Acesulfame potassium is widely used in beverages, cosmetics, foods, and pharmaceutical formulations and is generally regarded as a relatively nontoxic and nonirritant material. Pharmacokinetic studies have shown that acesulfame potassium is not metabolized and is rapidly excreted unchanged in the urine. Long-term feeding studies in rats and dogs showed no evidence to suggest acesulfame potassium is mutagenic or carcinogenic.(6) The WHO has set an acceptable daily intake for acesulfame potassium of up to 15 mg/kg body-weight.(6) LD50 (rat, IP): 2.2 g/kg(5) LD50 (rat, oral): 6.9–8.0 g/kg 15 Published by the Pharmaceutical Press Publications division of the Royal Pharmaceutical Society of Great Britain 1 Lambeth High Street, London SE1 7JN, UK 100 South Atkinson Road, Suite 206, Grayslake, IL 60030-7820, USA and the American Pharmacists Association 2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA # Pharmaceutical Press and American Pharmacists Association 2006 Glacial and diluted acetic acid solutions are widely used as acidifying agents in a variety of pharmaceutical formulations and food preparations. Acetic acid is used in pharmaceutical products as a buffer system when combined with an acetate salt such as sodium acetate. Acetic acid is also claimed to have some antibacterial and antifungal properties. Similar action to glidants, however, they may slow disintegration and dissolution. The properties of glidants and lubricants differ, although some compounds, such as starch and talc, have both actions.

MP Mullarney Pfizer Inc Groton, CT, USA S Murdande Pfizer Inc Groton, CT, USA RA Nash St John’s University Jamaica, NY, USA S Nema Pfizer Inc Chesterfield, MO, USA Ideally, an excipient is pharmacologically inactive, non-toxic, and does not interact with the active ingredients or other excipients. However, in practice few excipients meet these criteria. Toxicity may relate to compounds used as excipients in the final dosage form, or to residues of compounds (such as solvents) used during the manufacturing process. 2 Table 2 shows examples of adverse reactions that have occurred with excipients. Identification Appearance Characters Specific gravity Refractive index Sulfated ash Acidity Water Heavy metals Assay (anhydrous basis)

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The Handbook of Pharmaceutical Excipients collects together essential data on the physical properties of excipients as well as providing information on their safe use and applications. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. It is internationally recognized as the authoritative source of information on pharmaceutical excipients and a comprehensive guide to uses, properties and safety. Identification Characters Appearance of solution Acidity or alkalinity Relative density Related substances Matter insoluble in water Reducing substances Residue on evaporation Water Assay Saccharin ammonium Saccharin calcium Self-emulsifying glyceryl monostearate Shellolic acid Sodium bisulfite Sodium borate anhydrous Sodium edetate Sodium erythorbate Sodium laurate Sodium myristate Sodium palmitate Sodium sorbate Sodium sulfite heptahydrate Soft water Sorbitol solution 70% Spermaceti wax Stearalkonium hectorite Sterile water for inhalation Sterile water for injection Sterile water for irrigation Sunset yellow FCF Synthetic paraffin DL-(
)-Tartaric acid Tartrazine Theobroma oil Tocopherols excipient Tribasic sodium phosphate Trimethyl-b-cyclodextrin Trimethyltetradecylammonium bromide Trisodium edetate Virgin olive oil Water for injection White petrolatum Zinc propionate chlorofluorocarbon. centimeter(s). square centimeter(s). cubic centimeter(s). critical micelle concentration. central nervous system. centipoise(s). centistoke(s). Cosmetic, Toiletry, and Fragrance Association. designation applied in USA to dyes permitted for use in drugs and cosmetics. Department of Health (UK).