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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
is a container of a sterile preparation for parenteral use that contains many single doses.	Pharmacy bulk package
applies to a singledose injection that is intended for intravenous use and is packaged in containers labeled as containing more than 100 mL	Large volume intravenous solution
applies to an Injection that is packaged in containers labeled as containing 100 mL or less	Small volume Injection
generally is used as the vehicle, unless otherwise specified in the individual monograph	Water for Injection
may be added in amounts sufficient to render the resulting solution isotonic	Sodium chloride
may be used in whole or in part instead of Water for Injection, unless otherwise specified in the individual monograph	Sodium Chloride Injection, or Ringer's Injection
used as vehicles for nonaqueous Injections are of vegetable origin, are odorless or nearly so, and have no odor suggesting rancidity	Fixed oils
They (OTHER VEHICLES) meet the requirements of the test for: 1 Solid paraffin under Mineral Oil 2 Saponification Value 3 Iodine Value 4 free fatty acids	. 1 the cooling bath being maintained at 10. 2 between 185 and 200 Oils 3 between 79 and 141 4) 10 g of oil require for neutralization not more than 2.0 mL of 0.020 N sodium hydroxide
may be used as vehicles, provided they are liquid and remain clear when cooled to 10 and have an Iodine Value of not more than 140	Synthetic mono or diglycerides
No __ may be added, solely for the purpose of coloring the finished preparation, to a solution intended for parenteral administration	coloring agent
Suitable substances may be added to preparations intended for injection to __ unless proscribed in the individual monograph, provided they are __	increase stability or usefulness, HARMLESS in the amounts administered and do not interfere with the therapeutic efficacy or with the responses to the specified assays and tests.
Observe special care in the choice and use of added substances in preparations for injection that are administered in a volume exceeding __	5 mL
The following maximum limits prevail unless otherwise directed: 1 Mercury and the cationic, surfaceactive compounds 2) Chlorobutanol, cresol, phenol, and similar types of substances 3) Sulfur dioxide, or an equivalent amount of the sulfite, bisulfite, or metabisulfite of potassium or sodium	. 1) 0.01% 2) 0.5% 3) 0.2%
A suitable substance or mixture of substances to prevent the growth of microorganisms must be added to preparations intended for injection that are packaged in multiple dose containers, regardless of the method of sterilization employed Unless one of the following conditions prevails:	(1) there are different directions in the individual monograph; (2) the substance contains a radionuclide with a physical halflife of less than 24 hours; and (3) the active ingredients are themselves antimicrobial.
The labeling includes the following information if the complete formula is not specified in the individual monograph:	1 In the case of a liquid preparation, the percentage content of each ingredient, volume, except that ingredients added to adjust to a given pH or to make the solution isotonic may be declared by name and a statement of their effect 2 in dry preparation, the amount of each ingredient, the composition of recommended diluent(s)
Containers for Injections that are intended for use as dialysis, hemofiltration, or irrigation solutions and that contain a volume of more than 1 L are labeled to indicate that __ Injections intended for veterinary use are labeled to that effect	contents are not intended for use by intravenous infusion.