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level: level 4

Questions and Answers List

level questions: level 4

Question	Answer
Used when physical or chemical factors limit the use of a wholly aqueous vehicle QUALITIES: - nonirritating, nontoxic, and not sensitizing - must not exert a pharmacologic activity of its own, nor affect the activity of the medicinal agent - physical and chemical properties evaluated and determined: stability at various pH levels, viscosity, fluidity, boiling point, miscibility with body fluids, low vapor pressure and constant purity.	NONAQUEOUS VEHICLES
These should remain clear at 10°C in parenteral products (USP restrictions)	1 Fixed vegetable oils: corn oil, cottonseed oil, peanut oil, sesame oil
Nonaqueous solvents in Parenteral products	1 Fixed vegetable oils 2 Glycerin 3 Polyethylene glycols (PEG) 4 Propylene glycols 5 Alcohol Less often used agents: 1 Ethyl oleate, 2 Isopropyl myristate, 3 Dimethylacetamide
ADDED SUBSTANCES in injections USP permits addition of suitable substances:	1 Antibacterial preservatives 2 Buffers 3 Solubilizers 4 Antioxidants, and other adjuncts.
ADDED SUBSTANCE IN INJECTIONS are permitted by the USP as long as it is:	- to INCREASE STABILITY AND USEFULNESS - HARMLESS in the amounts administered - DO NOT INTERFERE WITH THE THERAPEUTIC EFFICACY of the preparation or with specified assays and tests.
Preservatives indicated maximum limits (ADDED SUBSTANCE) 1 Mercury and cationic surface active compounds 2 Chlorobutanol, cresol and phenol 3 Sulfite, bisulfite, metabisulfite 4 prevent reaction of oxygen and drug	. 1) 0.01% 2) 0.5% 3) 0.2% 4 Nitrogen