Handbook of pharmaceutical excipients: 6th Revised edition

Product Information

Acesulfame potassium is used as an intense sweetening agent in cosmetics, foods, beverage products, table-top sweeteners, vitamin and pharmaceutical preparations, including powder mixes, tablets, and liquid products. It is widely used as a sugar substitute in compounded formulations,(1) and as a toothpaste sweetener.(2) The approximate sweetening power is 180–200 times that of sucrose. It enhances flavor systems and can be used to mask some unpleasant taste characteristics. 8 Observe normal precautions appropriate to the circumstances and quantity of the material handled. When heated to decomposition, agar emits acrid smoke and fumes. 16

BP: Glacial acetic acid JP: Glacial acetic acid PhEur: Acidum aceticum glaciale USP: Glacial acetic acid

What Is Semantic Scholar?

Acetone is a colorless volatile, flammable, transparent liquid, with a sweetish odor and pungent sweetish taste. GRAS listed. Accepted for use in Europe as a food additive. Included in the FDA Inactive Ingredients Guide (oral preparations and buccal or sublingual tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 17

The USP 28 describes albumin human as a sterile nonpyrogenic preparation of serum albumin obtained from healthy human donors; see Section 13. It is available as a solution containing 4, 5, 20, or 25 g of serum albumin in 100 mL of solution, with not less than 96% of the total protein content as albumin. The solution contains no added antimicrobial preservative but may contain sodium acetyltryptophanate with or without sodium caprylate as a stablizing agent. The PhEur 2005 similarly describes albumin solution as an aqueous solution of protein obtained from human plasma; see Section 13. It is available 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. Not less than 95% of the total protein content is albumin. 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. Aqueous albumin solutions are slightly viscous and range in color from almost colorless to amber depending upon the protein concentration. In the solid state, albumin appears as brownish amorphous lumps, scales, or powder. 9 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. Acacia storage conditions, pH, and the presence of salts. Viscosity increases slowly up to about 25% w/v concentration and exhibits Newtonian behavior. Above this concentration, viscosity increases rapidly (non-Newtonian rheology). Increasing temperature or prolonged heating of solutions results in a decrease of viscosity owing to depolymerization or particle agglomeration. See also Section 12. Acesulfame potassium is synthesized from acetoacetic acid tertbutyl ester and fluorosulfonyl isocyanate. The resulting compound is transformed to fluorosulfonyl acetoacetic acid amide, which is then cyclized in the presence of potassium hydroxide to form the oxathiazinone dioxide ring system. Because of the strong acidity of this compound, the potassium salt is produced directly. An alternative synthesis route for acesulfame potassium starts with the reaction between diketene and amidosulfonic acid. In the presence of dehydrating agents, and after neutralization with potassium hydroxide, acesulfame potassium is formed. 14

My Book Notes

Notice to Readers The Handbook of Pharmaceutical Excipients is a reference work containing a compilation of information on the uses and properties of pharmaceutical excipients, and the reader is assumed to possess the necessary knowledge to interpret the information that the Handbook contains. The Handbook of Pharmaceutical Excipients has no official status and there is no intent, implied or otherwise, that any of the information presented should constitute standards for the substances. The inclusion of an excipient, or a description of its use in a particular application, is not intended as an endorsement of that excipient or application. Similarly, reports of incompatibilities or adverse reactions to an excipient, in a particular application, may not necessarily prevent its use in other applications. Formulators should perform suitable experimental studies to satisfy themselves and regulatory bodies that a formulation is efficacious and safe to use. While considerable efforts were made to ensure the accuracy of the information presented in the Handbook, neither the publishers nor the compilers can accept liability for any errors or omissions. In particular, the inclusion of a supplier within the 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 Included in the FDA Inactive Ingredients Guide for oral and sublingual preparations. Included in the Canadian List of Identification Appearance Characters Specific gravity Refractive index Sulfated ash Acidity Water Heavy metals Assay (anhydrous basis)

approximately. Addendum. acceptable daily intake. approximately. atmosphere. British Approved Name. boiling point. British Pharmacopoeia. British Standard (specification). British Standards Institution. calorie(s). Chemical Abstract Service. Agar-agar; Bengal isinglass; Ceylon isinglass; Chinese isinglass; E406; gelosa; gelose; Japan agar; Japan isinglass; layor carang. 3 Characters Identification Appearance of solution Acidity or alkalinity Acetylacetamide Impurity B and related substances Fluorides Heavy metals Loss on drying Assay Volume 1 cubic inch (in3) = 1.63871  10–5 cubic meter (m3) 1 cubic foot (ft3) = 2.83168  10–2 cubic meter (m3) 1 cubic yard (yd3) = 7.64555  10–1 cubic meter (m3) 1 pint (UK) = 5.68261  10–4 cubic meter (m3) 1 pint (US) = 4.73176  10–4 cubic meter (m3) 1 gallon (UK) = 4.54609  10–3 cubic meter (m3) 1 gallon (US) = 3.78541  10–3 cubic meter (m3) Agar is incompatible with strong oxidizing agents. Agar is dehydrated and precipitated from solution by ethanol (95%). Tannic acid causes precipitation; electrolytes cause partial dehydration and decrease in viscosity of sols.(9)

differential scanning calorimetry. European Community. exemplit gratia, ‘for example’. European Inventory of Existing Commercial Chemical Substances. et alii, ‘and others’. European Union. Food and Agriculture Organization of the United Nations. Food and Agriculture Organization of the United Nations and the World Health Organization. Food Chemicals Codex. Food and Drug Administration of the USA. designation applied in USA to dyes permitted for use in foods, drugs, and cosmetics. Flat face beveled edge. gram(s). Good Manufacturing Practice. generally recognized as safe by the Food and Drug Administration of the USA. hydrocarbon. hydrochlorofluorocarbon. hydrofluorocarbon. human immunodeficiency virus. hydrophilic–lipophilic balance. Health and Safety Executive (UK). id est, ‘that is’. intramuscular. International Nonproprietary Name. intraperitoneal. International Organization for Standardization. International Units. intravenous. joule(s). Japanese Pharmacopeia. Japanese Pharmaceutical Excipients kilocalorie(s). kilogram(s). kilojoule(s). kilopascal(s). liter(s). Limulus amoebocyte lysate. a concentration in air lethal to 50% of the specified animals on inhalation. a dose lethal to 50% of the specified animals or microorganisms. lowest lethal dose for the specified animals or microorganisms. meter(s). square meter(s). cubic meter(s). molar. maximum. Medicines Control Agency (UK). 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 mg MIC min mL mm mM mm2 mm3 mmHg mmol mN mol mp mPa MPa mg mm N nm o/w o/w/o Pa pH PhEur pKa pph ppm psia RDA rpm s SC SEM SI TPN TWA UK US or USA USAN USP USPNF UV v/v v/w WHO w/o w/o/w w/v w/w Glacial acetic acid occurs as a crystalline mass or a clear, colorless volatile solution with a pungent odor.

Acetone is used as a solvent or cosolvent in topical preparations, and as an aid in wet granulation.(1,2) It has also been used when formulating tablets with water-sensitive active ingredients, or to solvate poorly water-soluble binders in a wet granulation process. Acetone has also been used in the formulation of microspheres to enhance drug release.(3) Owing to its low boiling point, acetone has been used to extract thermolabile substances from crude drugs.(4) 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 Acceptable Non-medicinal Ingredients. Accepted for use in Europe as a food additive. It is also accepted for use in certain food products in the USA and several countries in Central and South America, the Middle East, Africa, Asia, and Australia. 17Boiling point: 56.28C Flash point: –208C Melting point: 94.38C Refractive index: n20 D = 1.359 Solubility: soluble in water; freely soluble in ethanol (95%) Vapor pressure: 185 mmHg at 208C 11 Human serum albumin has a molecular weight of about 66 500 and is a single polypeptide chain consisting of 585 amino acids. Characteristic features are a single tryptophan residue, a relatively low content of methionine (6 residues), and a large number of cysteine (17) and of charged amino acid residues of aspartic acid (36), glutamic acid (61), lysine (59), and arginine (23). 5 thanks for their support over many years. Thanks are also extended to excipient manufacturers and suppliers who provided helpful information on their products. Thanks are also gratefully extended to the staff of the Pharmaceutical Press and American Pharmacists Association who were involved in the production of the Handbook: Eric Connor, Tamsin Cousins, Simon Dunton, Laurent Galichet, Julian Graubart, Louise McIndoe, Karl Parsons, Paul Weller, and John Wilson. Once again, the diligent copy-editing and challenging questions asked by Len Cegielka helped the authors and editors, we hope, to express their thoughts clearly, concisely, and accurately. Raymond C Rowe, Paul J Sheskey and Siaˆn C Owen August 2005