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. 17 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

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) 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) All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. Identification Specific gravity Refractive index Acidity Water Heavy metals Assay (anhydrous basis)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 hamster, oral): 6.1 g/kg(10) (mouse, oral): 16.0 g/kg (rabbit, oral): 5.8 g/kg (rat, oral): 11.0 g/kg 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. 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.

Identification Characters Appearance of solution Acidity or alkalinity Relative density Related substances Matter insoluble in water Reducing substances Residue on evaporation Water Assay 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 Abbreviations Some units, terms, and symbols are not included in this list as they are defined in the text. Common abbreviations have been omitted. The titles of journals are abbreviated according to the general style of the Index Medicus.  Ad ADI approx atm BAN bp BP BS BSI cal CAS 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. 17The 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 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. You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer H Wang Pfizer Inc Groton, CT, USA PJ Weller Royal Pharmaceutical Society of Great Britain London, UK AJ Winfield Aberdeen, UK 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

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 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 Acetyltriethyl citrate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritating material. However, ingestion of large quantities may be harmful. LD50 (cat, oral): 8.5 g/kg(7) LD50 (mouse, IP): 1.15 g/kg LD50 (rat, oral): 7 g/kg 15 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 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.Protect 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. Boiling 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