Handbook of pharmaceutical excipients: 6th Revised edition

Product Information

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

Identification Characters Appearance of solution Acidity or alkalinity Relative density Related substances Matter insoluble in water Reducing substances Residue on evaporation Water Assay 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 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 15Improve the flow of powders during tablet manufacturing by reducing friction and adhesion between particles. Also used as anti-caking agents. 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

Observe normal precautions appropriate to the circumstances and quantity of material handled. Acacia can be irritant to the eyes and skin and upon inhalation. Gloves, eye protection, and a dust respirator are recommended. 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 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. Bonding index: 0.007 Brittle fracture index: 0.08(3) Flowability: 19% (Carr compressibility index)(3) Density (bulk): 1.04 g/cm3(3) Density (tapped): 1.28 g/cm3(3) Elastic modulus: 4000 MPa(3) Melting point: 2508C Solubility: see Table II. Specific volume: 0.538 cm3/g(4) Tensile strength: 0.5 MPa(3) Viscoelastic index: 2.6(3)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) Acacia is available as white or yellowish-white thin flakes, spheroidal tears, granules, powder, or spray-dried powder. It is odorless and has a bland taste. 9 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 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.