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Handbook of pharmaceutical excipients: 6th Revised edition

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Albuconn; albumin human solution; Albuminar; Albumisol; Albuspan; Albutein; Buminate; human serum albumin; normal human serum albumin; Plasbumin; plasma albumin; ProBumin; Proserum. 3 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 Acetone is a colorless volatile, flammable, transparent liquid, with a sweetish odor and pungent sweetish taste. Written by over 160 pharmaceutical scientists from around the world, expert in the manufacture, analysis or use of excipients. It is an essential reference for those involved in the development, production, control and regulation of pharmaceutical preparations.

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)

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Acacia is the dried gummy exudate obtained from the stems and branches of Acacia senegal (Linne´) Willdenow or other related species of Acacia (Fam. Leguminosae) that grow mainly in the Sudan and Senegal regions of Africa. The bark of the tree is incised and the exudate allowed to dry on the bark. The dried exudate is then collected, processed to remove bark, sand, and other particulate matter, and graded. Various acacia grades differing in particle size and other physical properties are thus obtained. A spray-dried powder is also commercially available. 14 Identification Characters Appearance of solution Acidity or alkalinity Relative density Related substances Matter insoluble in water Reducing substances Residue on evaporation Water Assay 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 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). 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

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 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.

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. Total ash Acid-insoluble ash Insoluble residue Arsenic Lead Heavy metals Starch, dextrin, and agar Tannin-bearing gums Tragacanth Sterculia gum Glucose and fructose Solubility and reaction Organic volatile impurities (a) GE Amidon Pharmacia Corporation Kalamazoo, Michigan, USA GP Andrews The Queen’s University of Belfast Belfast, UK

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/kgAcetyltributyl citrate is prepared by the esterification of citric acid with butanol followed by acylation with acetic anhydride. Paul J. Sheskey - Principal Research Scientist (retired), The Dow Chemical Company, Midland, MI, USA; been more selective in including data relating to the physical properties of an excipient. However, comparative data that show differences between either source or batch of a specific excipient have been retained as this was considered relevant to the behavior of a material in practice. The Suppliers Directory (Appendix I) has also been completely updated with many more international suppliers included. In a systematic and uniform manner, the Handbook of Pharmaceutical Excipients collects essential data on the physical properties of excipients such as: boiling point, bulk and tap density, compression characteristics, hygroscopicity, flowability, melting point, moisture content, moisture-absorption isotherms, particle size distribution, rheology, specific surface area, and solubility. Scanning electron microphotographs (SEMs) are also included for many of the excipients. The Handbook contains information from various international sources and personal observation and comments from monograph authors, steering committee members, and the editors. All of the monographs in the Handbook are thoroughly cross-referenced and indexed so that excipients may be identified by either a chemical, a nonproprietary, or a trade name. Most monographs list related substances to help the formulator to develop a list of possible materials for use in a new dosage form or product. Related substances are not directly substitutable for each other but, in general, they are excipients that have been used for similar purposes in various dosage forms. The Handbook of Pharmaceutical Excipients is a comprehensive, uniform guide to the uses, properties, and safety of pharmaceutical excipients, and is an essential reference source for those involved in the development, production, control, or regulation of pharmaceutical preparations. Since many pharmaceutical excipients are also used in other applications, the Handbook of Pharmaceutical Excipients will also be of value to persons with an interest in the formulation or production of confectionery, cosmetics, and food products. Observe normal precautions appropriate to the circumstances and quantity of material handled. Acetyltriethyl citrate may be irritating to the eyes or the respiratory system as a mist or at elevated temperatures. Gloves and eye protection are recommended for normal handling and a respirator is recommended if used at elevated temperatures. 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 recognised as the authoritative source of information on pharmaceutical excipients and a comprehensive guide to uses, properties and safety.

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