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Compounding This Week Newsletter from www.CompoundingToday.com
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October 27, 2023  |  Volume 20  |  Issue 42
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Loyd V. Allen, Jr., Ph.d., R.Ph United States Pharmacopeia <101>, Part 12

Composition of the USP Pharmacists Pharmacopeia (Cont'd)

In a previous Newsletter edition on this topic, we mentioned the Reference Tables and how useful they can be to compounding pharmacists. In this edition, we are reprinting some of the entries contained in the Reference Tables to illustrate their usefulness. This information is from United States Pharmacopeia 36.

Reference Tables: United States Pharmacopeia 36

Description and Solubility

Opium: Has a very characteristic odor and a very bitter taste.

Orbifloxacin: White to pale yellow crystals or crystalline powder. Odorless. Soluble in acetic acid; very slightly soluble in methanol, in water, and in chloroform; practically insoluble in ethanol and in diethyl ether.

Orlistat: White to off-white fine powder or fine powder with lumps. Freely soluble in chloroform; very soluble in methanol and in alcohol; practically insoluble in water.

Orphenadrine Citrate: White, practically odorless, crystalline powder, having a bitter taste. Sparingly soluble in water; slightly soluble in alcohol; insoluble in chloroform, in benzene, and in ether.

Oseltamivir Phosphate: White to off-white powder. Freely soluble in water; soluble in methanol, in dimethyl sulfoxide, and in propylene glycol; sparingly soluble in dimethylformamide; slightly soluble in alcohol; very slightly soluble in isopropyl alcohol and in polyethylene glycol 400; practically insoluble in acetonitrile, in acetone, in dichloromethane, and in n-hexane.

Oxacillin Sodium: Fine, white, crystalline powder, odorless or having a slight odor. Freely soluble in water, in solute alcohol, in chloroform, in pyridine, and in methyl acetate; insoluble in ethyl acetate, in ether, in benzene, and in ethylene chloride.

Oxacillin Sodium for Injection: Fine, white, crystalline powder, odorless or having a slight odor. Freely soluble in water, in methanol, and in dimethyl sulfoxide; slightly soluble in absolute alcohol, in chloroform, in pyridine, and in methyl acetate; insoluble in ethyl acetate, in ether, in benzene, and in ethylene chloride.

Oxaliplatin: White to off-white crystalline powder. Slightly soluble in water; very slightly soluble in methanol; practically insoluble in alcohol.

Oxandrolone: White, odorless, crystalline powder. Is stable in air, but darkens on exposure to light. Melts at about 225°. Freely soluble in chloroform; sparingly soluble in alcohol and in acetone; practically insoluble in water.

Oxaprozin: White to yellowish-white, crystalline powder.

Oxazepam: Creamy white to pale yellow powder. Is practically odorless. Slightly soluble in alcohol and in chloroform; very slightly soluble in either; practically insoluble in water.

Oxcarbazepine: Light orange to creamish white or off-white powder. Soluble in acetic acid; sparingly soluble in chloroform; practically insoluble in water.

Oxfendazole: White or almost white powder. Slightly soluble in alcohol and in methylene chloride; practically insoluble in water.

Oxprenolol Hydrochloride: White, crystalline powder. Freely soluble in alcohol, in chloroform, and in water; sparingly soluble in acetone; practically insoluble in ether.

Oxtriphylline: White, crystalline powder, having an amine-like odor. A solution (1 in 100) has a pH of about 10.3. Freely soluble in water and in alcohol; very slightly soluble in chloroform.

Oxybenzone: Pale yellow powder. Freely soluble in alcohol and in toluene; practically insoluble in water.

Oxybutynin Chloride: White, crystalline, practically odorless powder. Very soluble in methanol and in chloroform; freely soluble in water and in alcohol; soluble in acetone; slightly soluble in ether; very slightly soluble in hexane.

Oxycodone Hydrochloride: White to off-white, hygroscopic crystals or powder. Is odorless. Soluble in water; slightly soluble in alcohol.

Oxygen: Colorless, odorless, tasteless gas, which supports combustion more energetically than does air.

Oxymetazoline Hydrochloride: White to practically white, fine crystalline powder. Is hygroscopic. Melts at about 300°, with decomposition. Soluble in water and in alcohol; practically insoluble in benzene, in chloroform, and in ether.

Oxymetholone: White to creamy white, crystalline powder. Is odorless, and is stable in air. Freely soluble in chloroform; soluble in dioxane; sparingly soluble in alcohol; slightly soluble in ether; practically insoluble in water.

Oxymorphone Hydrochloride: White or slightly off-white, odorless powder. Darkens on exposure to light. Its aqueous solutions are slightly acidic. Freely soluble in water; sparingly soluble in alcohol and in ether.

Oxyquinoline Sulfate: Yellow powder. Melts at about 185°. Very soluble in water; freely soluble in methanol; slightly soluble in alcohol; practically insoluble in acetone and in ether. NF category: Complexing agent.

Oxytetracycline: Pale yellow to tan, odorless, crystalline powder. Is stable in air, but exposure to strong sunlight causes it to darken. It loses potency in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Freely soluble in 33 N hydrochloric acid and in alkaline solutions; sparingly soluble in alcohol; very slightly soluble in water.

Oxytetracycline Calcium: Yellow to light brown, crystalline powder. Insoluble in water.

Oxytetracycline Hydrochloride: Yellow, odorless, crystalline powder, having a bitter taste. Is hygroscopic. Decomposes at a temperature exceeding 180°, and exposure to strong sunlight or to temperatures exceeding 90° in moist air causes it to darken. Its potency is diminished in solutions having a pH below 2, and is rapidly destroyed by alkali hydroxide solutions. Freely soluble in water, but crystals of oxytetracycline base separate as a result of partial hydrolysis of the hydrochloride; sparingly soluble in alcohol and in methanol, and even less soluble in dehydrated alcohol; insoluble in chloroform and in ether.

Paclitaxel: White to off-white powder. Soluble in alcohol; insoluble in water.

Padimate O: A light yellow, mobile liquid having a faint, aromatic odor. Soluble in alcohol, in isopropyl alcohol, and in mineral oil; practically insoluble in water, in glycerin, and in propylene glycol.

Palm Oil: White to yellowish, fatty solid to semisolid. Insoluble in water. NF category: Coating agent; emulsifying and/or solubilizing agent.

Hydrogenated Palm Oil: White to yellowish, fatty solid to semi-solid. Freely soluble in ether; very slightly soluble in alcohol; practically insoluble in water. NF category: Coating agent; tablet binder; tablet and/or capsule lubricant.

Palm Kernel Oil: White to yellowish, fatty solid. Insoluble in water. NF category: Coating agent; emulsifying and/or solubilizing agent.

Palmitic Acid: Hard, white or faintly yellow, somewhat glossy crystalline solid, or white or yellowish-white powder. It has a slight characteristic odor and taste. Soluble in alcohol, in ether, and in chloroform; practically insoluble in water.

Pamidronate Disodium: White, crystalline powder. Soluble in water and in 2 N sodium hydroxide; sparingly soluble in 0\.1 N hydrochloric acid and in 0.1 N acetic acid; practically insoluble in organic solvents.

Pancreatin: Cream-colored, amorphous powder, having a faint, characteristic, but not offensive odor. It hydrolyzes fats to glycerol and fatty acids, changes protein into proteoses and derived substances, and converts starch into dextrins and sugars. Its greatest activities are in neutral or faintly alkaline media; more than traces of mineral acids or large amounts of alkali hydroxides make it inert. An excess of alkali carbonate also inhibits its action.

Pancrelipase Capsules: Cream-colored, amorphous powder, having a faint, characteristic, but not offensive odor. Pancrelipase hydrolyzes fats to glycerol and fatty acids, changes protein into proteoses and derived substances, and converts starch into dextrins and sugars. Its greatest activities are in neutral or faintly alkaline media; more than traces of mineral acids or large amounts of alkali hydroxides make it insert. An excess of alkali carbonate also inhibits its action.

Pancrelipase Capsules: The contents of Capsules conform to the Description under Pancrelipase, except that the odor may vary with the flavoring agent used.

Pancuronium Bromide: White, yellowish-white, or slightly pink, crystalline powder. Is hydroscopic. Freely soluble in water, in methylene chloride, and in alcohol.

Panthenol: White to creamy white, crystalline powder having a slight, characteristic odor. Freely soluble in water, in alcohol, and in propylene glycol; soluble in chloroform and in ether; slightly soluble in glycerin.

Pantoprazole Sodium: White to off-white powder. Freely soluble in water, in methanol, and in dehydrated alcohol; practically insoluble in hexane and in dichloromethane.

Papain: White to light tan, amorphous powder. Soluble in water, the solution being colorless to light yellow and more or less opalescent; practically insoluble in alcohol, in chloroform, and in ether.

Papaverine Hydrochloride: White crystals or white, crystalline powder. Is odorless, and has a slightly bitter taste. Is optically inactive. Its solutions are acid to litmus. Melts at about 220°, with decomposition. Soluble in water and in chloroform; slightly soluble in alcohol; practically insoluble in ether.

Parachlorophenol: White or pink crystals having a characteristic phenolic odor. When undiluted, it whitens and cauterizes the skin and mucous membranes. Melts at about 42°. Very soluble in alcohol, in glycerin, in chloroform, in ether, and in fixed and volatile oils; soluble in petrolatum; sparingly soluble in water and in liquid petrolatum.

Paraffin: Colorless or white, more or less translucent mass showing a crystalline structure. Is odorless and tasteless, and is slightly greasy to the touch. Freely soluble in chloroform, in ether, in volatile oils, and in most warm fixed oils; slightly soluble in dehydrated alcohol; insoluble in water and in alcohol. NF category: Stiffening agent.



Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

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