Table III: Specifications of different stearic acid grades.
CAS number: [57-11-4] Synonyms: octadecanoic acid. Acid value: 195–200
Boiling point: 3618C Density: 0.847 g/cm3 at 708C Flash point: 1968C
Refractive index: n80 = 1.4299
Solubility: soluble 1 in 5 parts benzene, 1 in 6 parts carbon
Vapor density (relative): 9.80 (air = 1)
The EINECS number for stearic acid is 200-313-4.
Suzuki K. Rheological study of vanishing cream. Cosmet Toilet
Mores LR. Application of stearates in cosmetic creams and lotions.
Cosmet Toilet 1980; 95(3): 79, 81–84.
Yalkowsky SH, He Y, eds. Handbook of Solubility Data. Boca Raton, FL: CRC Press; 2003: 1119–1120.
Rowe RC, Forse SF. Pitting: a defect on film-coated tablets. Int J Pharm 1983; 17: 347–349.
BP: Stearyl alcohol JP: Stearyl alcohol
PhEur: Alcohol stearylicus USPNF: Stearyl alcohol
Chemical Name and CAS Registry Number
Empirical Formula and Molecular Weight
C18H38O 270.48 (for pure material)
Table I: Pharmacopeial specifications for stearyl alcohol.
Test JP 2001 PhEur 2005 USPNF 23
Melting range 56–628C 57–608C 55–608C
Hydroxyl value 200–220 197–217 195–220
Residue on ignition 40.05% — —
Assay (of C18H38O) — 595% 590.0%
Autoignition temperature: 4508C
Boiling point: 210.58C at 2 kPa (15 mmHg)
Density (true): 0.884–0.906 g/cm3(10) Flash point: 1918C (open cup) Freezing point: 55–578C
Melting point: 59.4–59.88C for the pure material.
Refractive index: n60 = 1.4388 at 608C
soluble in chloroform, ethanol (95%), ether, hexane,
Applications in Pharmaceutical Formulation or Technology
propylene glycol, and vegetable oils; practically insoluble in water.
Vapor pressure: 133.3 Pa (1 mmHg) at 150.38C
Viscosity (dynamic): 9.82 mPa s at 648C(10)
Stability and Storage Conditions
Incompatible with strong oxidizing agents and strong acids.
The probable lethal oral human dose is greater than 15 g/kg.
Cetostearyl alcohol; cetyl alcohol.
The EINECS number for stearyl alcohol is 204-017-6.
Egan RR, Portwood O. Higher alcohols in skin lotions. Cosmet Perfum 1974; 89(3): 39–42.
Alexander P. Organic rheological additives. Manuf Chem 1986;
Gaul LE. Dermatitis from cetyl and stearyl alcohols. Arch Dermatol 1969; 99: 593.
Cronin E. Contact Dermatitis. Edinburgh: Churchill Livingstone, 1980: 808.
Splenda; TGS; 1',4',6'-trichlorogalactosucrose; 4,1',6'-tri-
chloro-4,1',6'-trideoxy-galacto-sucrose.
Chemical Name and CAS Registry Number
1,6-Dichloro-1,6-dideoxy-b-D-fructofuranosyl-4-chloro-4- deoxy-a-D-galactopyranoside [56038-13-2]
Empirical Formula and Molecular Weight
Applications in Pharmaceutical Formulation or Technology
Sucralose is a white to off-white colored, free-flowing, crystal- line powder.
Table II: Pharmacopeial specifications for sucralose.
Specific rotation +84.08 to +87.58
Limit of hydrolysis products 40.1%
Assay (dried basis) 98.0–102.0%
Acidity/alkalinity: pH = 5–6 (10% w/v aqueous solution at 208C)
Density (bulk): 0.35 g/cm3 Density (tapped): 0.62 g/cm3 Density (true): 1.63 g/cm3
Melting point: 1308C (for anhydrous crystalline form); 36.58C (for pentahydrate).
Particle size distribution: 90% < 12 mm in size.
Partition coefficient: log10 P = —0.51 (octanol:water)
Refractive index: 1.33 to 1.37
Solubility: freely soluble in ethanol (95%), methanol, and water; slightly soluble in ethyl acetate.
Stability and Storage Conditions
extended storage periods, even at low pH. However, it is most stable at pH 5–6.
The WHO has set an acceptable daily intake for sucralose of up to 15 mg/kg body-weight.(4)
LD50 (mouse, oral): > 16 g/kg LD50 (rat, oral): > 10 g/kg
Observe normal precautions appropriate to the circumstances and quantity of material handled.
Tate and Lyle. Technical literature: Sucralose. 2001.
PhEur: Saccharum USPNF: Sucrose
Beet sugar; cane sugar; a-D-glucopyranosyl-b-D-fructofurano- side; refined sugar; saccharose; sugar.
Chemical Name and CAS Registry Number
b-D-fructofuranosyl-a-D-glucopyranoside [57-50-1]
Empirical Formula and Molecular Weight
Applications in Pharmaceutical Formulation or Technology
Sucrose is widely used in oral pharmaceutical formulations.
Sucrose has been used as a diluent in freeze-dried protein products.(5,6)
Syrup for oral liquid formulations 67
Tablet binder (dry granulation) 2–20
Tablet binder (wet granulation) 50–67
0.93 g/cm3 (crystalline sucrose);
0.60 g/cm3 (powdered sucrose).
0.82 g/cm3 (powdered sucrose). Density (true): 1.6 g/cm3 Dissociation constant: pKa = 12.62
Flowability: crystalline sucrose is free flowing, whereas powdered sucrose is a cohesive solid.
Melting point: 160–1868C (with decomposition)
Moisture content: finely divided sucrose is hygroscopic and absorbs up to 1% water.(9) See Figure 1.
Osmolarity: a 9.25% w/v aqueous solution is isoosmotic with serum.
Table II: Pharmacopeial specifications for sucrose.
Test JP 2001 PhEur 2005 USPNF 23
Specific optical +66.38 to +66.38 to 5+65.98
Bacterial endotoxins(a) 40.25 IU/mg 40.25 IU/mg —
Residue on ignition — — 40.05%
(a) If sucrose is to be used in large volume infusions.
Refractive index: n25 = 1.34783 (10% w/v aqueous solution)
Manufacturer: Great Western Sugar Co.
Manufacturer: Great Western Sugar Co.
Specific gravity: see Table IV.
Table III: Solubility of sucrose.
Solvent Solubility at 208C unless otherwise stated
Chloroform Practically insoluble
Table IV: Specific gravity of aqueous sucrose solutions.
Concentration of aqueous sucrose solution (% w/w) Specific gravity at 208C
Stability and Storage Conditions
w/w concentration. Aqueous solutions may be sterilized by autoclaving or filtration.
The bulk material should be stored in a well-closed container in a cool, dry place.
Figure 1: Moisture sorption–desorption isotherm of powdered sucrose.
Figure 2: Particle size distribution of crystalline sucrose.
Figure 3: Particle size distribution of powdered sucrose.
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