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 Acetone is considered moderately toxic, and is a skin irritant and severe eye irritant. Skin irritation has been reported due to its defatting action, and prolonged inhalation may result in headaches. Inhalation of acetone can produce systemic effects such as conjunctival irritation, respiratory system effects, nausea, and vomiting.(5) LD50 LD50 LD50 LD50

Agar-agar; Bengal isinglass; Ceylon isinglass; Chinese isinglass; E406; gelosa; gelose; Japan agar; Japan isinglass; layor carang. 3 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. A specification for acetone is included in the Japanese Pharmaceutical Excipients (JPE).(7) The EINECS number for acetone is 200-662-2. Identification Characters Swelling index Arsenic Lead Sulfuric acid Sulfurous acid and starch Gelatin Heavy metals Insoluble matter Water absorption Loss on drying Microbial contamination Total ash Acid-insoluble ash Foreign organic matter Limit of foreign starch Organic volatile impurities Dilute ammonia solution Dilute hydrochloric acid Dilute phosphoric acid Dilute sulfuric acid Dimethyl-b-cyclodextrin Dioctyl phthalate Dipotassium edetate Docusate calcium Docusate potassium Dodecyl gallate Dodecyltrimethylammonium bromide Edetate calcium disodium Eglumine Ethyl gallate Ethylene glycol monopalmitate Ethylene glycol monostearate Ethyl linoleate Ethylparaben potassium Ethylparaben sodium Extra virgin olive oil Fine virgin olive oil Fuming sulfuric acid Gamma tocopherol Hard water Hesperidin Hexadecyltrimethylammonium bromide High-fructose syrup Hyaluronic acid Hydrogenated lanolin Hydrogenated vegetable oil, type II 2-Hydroxyethyl-b-cyclodextrin 2-Hydroxypropyl-b-cyclodextrin 3-Hydroxypropyl-b-cyclodextrin Indigo carmine Invert sugar Isotrehalose Lampante virgin olive oil Lanolin alcohols ointment DL-Leucine Liquefied phenol Liquid fructose Magnesium carbonate anhydrous Magnesium carbonate hydroxide Magnesium lauryl sulfate Magnesium metasilicate Magnesium orthosilicate Magnesium trisilicate anhydrous D-Malic acid L-Malic acid d-Menthol l-Menthol Methyl lactate Methyl linoleate Methyl methacrylate Methyl oleateProtect tablet from the environment (air, light and moisture), increase the mechanical strength, mask taste and smell, aid swallowing, assist in product identification. Can be used to modify release of the active ingredient. May contain flavours and colourings. 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 Agar is a dried, hydrophilic, colloidal polysaccharide complex extracted from the agarocytes of algae of the Rhodophyceae. The structure is believed to be a complex range of polysaccharide chains having alternating a-(1!3) and b-(1!4) linkages. There are three extremes of structure noted: namely neutral agarose; pyruvated agarose having little sulfation; and a sulfated galactan. Agar can be separated into a natural gelling fraction, agarose, and a sulfated nongelling fraction, agaropectin. 6 Acetyltriethyl citrate is used to plasticize polymers in formulated pharmaceutical coatings.(1) The coating applications include capsules, tablets, beads and granules for taste masking, immediate release, sustained-release and enteric formulations.(2–5) It is also used in diffusion-controlled release drug delivery systems.(6) Suppliers Directory is not intended as an endorsement of that supplier or its products and, similarly, the unintentional omission of a supplier or product from the directory is not intended to reflect adversely on that supplier or its product. Although diligent effort was made to use as recent compendial information as possible, compendia are frequently revised and the reader is urged to consult current compendia, or supplements, for up-to-date information, particularly as efforts are currently in progress to harmonize standards for excipients. Data presented for a particular excipient may not be representative of other batches or samples. Relevant data and constructive criticism are welcome and may be used to assist in the preparation of any future editions or electronic versions of the Handbook. The reader is asked to send any comments to the Editor, Handbook of Pharmaceutical Excipients, Royal Pharmaceutical Society of Great Britain, 1 Lambeth High Street, London SE1 7JN, UK, or Editor, Handbook of Pharmaceutical Excipients, American Pharmacists Association, 2215 Constitution Avenue, NW, Washington, DC 20037-2985, USA.

Acidity/alkalinity: pH = 2.4 (1 M aqueous solution); pH = 2.9 (0.1 M aqueous solution); pH = 3.4 (0.01 M aqueous solution). Boiling point: 1188C Dissociation constant: pKa = 4.76 Flash point: 398C (closed cup); 578C (open cup). Melting point: 178C Refractive index: n20 D = 1.3718 Solubility: miscible with ethanol, ether, glycerin, water, and other fixed and volatile oils. Specific gravity: 1.045 11 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. About the Editors Raymond C Rowe BPharm, PhD, DSc, FRPharmS, CChem, FRSC, CPhys, MInstP Raymond Rowe has been involved in the Handbook of Pharmaceutical Excipients since the first edition was published in 1986, initially as an author then as a Steering Committee member. In addition to his position as Chief Scientist at Intelligensys, UK, he is also Professor of Industrial Pharmaceutics at the School of Pharmacy, University of Bradford, UK. He was formerly Senior Principal Scientist at AstraZeneca, UK. In 1998 he was awarded the Chiroscience Industrial Achievement Award, and in 1999 he was the British Pharmaceutical Conference Science Chairman. He has contributed to over 350 publications in the pharmaceutical sciences including a book and eight patents. Paul J Sheskey BSc, RPh Paul Sheskey has been involved in the Handbook of Pharmaceutical Excipients as an author and member of the Steering

Included in the FDA Inactive Ingredients Guide (inhalation solution; oral tablets; topical preparations). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 17

albumin loss. However, the benefits of using albumin in such applications in critically ill patients has been questioned.(5) 8 Compounds which swell or dissolve in water e.g. starch, cellulose derivatives and alginates, crospovidoneAgar solutions are most stable at pH 4–10. Agar should be stored in a cool, dry, place. Containers of this material may be hazardous when empty since they retain product residues (dust, solids). Paul J. Sheskey - Principal Research Scientist (retired), The Dow Chemical Company, Midland, MI, USA; Observe normal precautions appropriate to the circumstances and quantity of the material handled. When heated to decomposition, agar emits acrid smoke and fumes. 16