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36 Cards in this Set

  • Front
  • Back
chemicals substances dissolved in vehicles or solvents. They may be active ingredients or added substances
Active ingredients
drugs that exert a therapeutic effect
Added Substances
increase stability or usefulness of the parenteral product without causing harm or interfering with therapeutic efficacy.
Antimicrobial Preservative
an added substance used in liquid and semi-solid preparations to prevent growth of microorganisms. Examples include benzyl alcohol, parabens, benzalkonium chloride.
pH buffers
an added substance used to stabilize an aqueous solution of a chemical against degradation caused by changes in pH upon dilution or addition of acid or alkali. Examples include acid salts such as citrates, acetates or phosphates.
an added substance that inhibits oxidation of the active drug. Examples include sodium and potassium salts of sulfite, bisulfite and metasulfite ions.
Drug Injection
liquid preparations that are drug substances or solutions
Drug For Injection
dry solids that must be constituted or reconstituted with a suitable liquid vehicle to yield a drug injection solution
Drug Injectable Emulsion
liquid preparations in which drug substances are dissolved or dispersed in a suitable emulsion medium
Drug Injectable Suspension
liquid preparations in which drug substances are dissolved or dispersed in a suitable emulsion medium
Drug For Injectable Suspension
dry solids that must be constituted or reconstituted with a suitable liquid medium to yield a drug injectable suspension
holds the preparation and is or may be in direct contact with the preparation but it must not interact physically or chemically with the preparation so as to alter its strength or efficacy. The closure is part of the container. For sterile products, containers must be sterile, pyrogen-free, and free of particulate matter.
Single-dose container
a container holding a quantity of sterile drug intended for parenteral or ophthalmic administration as a single dose. Once opened, it cannot be re-sealed or re-used. Examples include ampuls or single-dose vials.
Multiple-dose container
contain antimicrobial preservatives so that successive portions of the preparation can be withdrawn without changing the strength, quality or purity of the remaining portion.
type 1 glass (borosilicate glass) is the type of glass most commonly used in sterile product containers as it is the most resistant to attack by water and chemicals with the least amount of incompatibilities
plastic polymers can be used to contain sterile products but there are three issues: 1) permeation of vapors and other molecules in either direction through the container; 2) leaching of contents from the plastic into the product; 3) sorption of drug molecules onto the plastic
the movement of components of a container into the contents. Can be common with plastic containers which leach polymer additives such as plasticizers, stabilizers or antioxidants
binding of molecules in the drug preparation to the polymer materials
an agent used to dissolve a pharmaceutic substance or drug in the preparation of a solution; it must be aqueous or nonaqueous
solvent or medium for liquid sterile products (a carrying agent for a drug substance), they have no therapeutic activity or toxicity
Water For Injection, USP
water purified by distillation or reverse osmosis and free of pyrogens. It is NOT sterile and injectable products made with Water For Injection should be sterilized after preparation
Sterile Water for Injection, USP
water which has been sterilized and packaged in single dose containers no larger than 1000 mL. It is pyrogen-free. Large volumes should not be administered intravenously because they have no tonicity.
Bacteriostatic Water for Injection, USP
sterile water for injection containing one or more antimicrobial agents and packaged in syringes or vials containing not more than 30 mL of water. The presence of antimicrobial agents allows for multiple-dose vials. This water can only be used in parenterals administered in small volumes (5 mL or less) as excessive amounts of antimicrobial agents may be toxic. For this reason, USP labeling requirements demand that the label state, “Not for Use in Newborns.”
Sodium Chloride Injection, USP
sterile isotonic solution of sodium chloride in Water for Injection (154 mEq of sodium and chloride ions per liter).
Bacteriostatic Sodium Chloride Injection, USP
sterile isotonic solution of 0.9% sodium chloride in Water for Injection plus one or more suitable antimicrobial agents. This solution may only be packaged in containers of 30 mL or less and the warning “NOT for Use in Newborns” must be stated on the label.
Ringer's Injection, USP
sterile solution of sodium chloride, potassium chloride and calcium chloride (in concentrations similar to physiologic fluids) in Water for Injection.
Lactated Ringer’s Injection, USP
contains the same three salts as Ringer’s Injection in different quantities and also contains sodium lactate.
Water-Miscible Solvents
used as a portion of the vehicle in sterile products to dissolve drugs with low water solubility. Examples include ethyl alcohol, liquid polyethylene glycol and propylene glycol. Preparations are usually administer intramuscularly.
Nonaqueous Vehicles
fixed oils used to prepare some parenteral products such as vitamins and hormones (also called oleaginous). USP requires that fixed oils be vegetable (metabolizable) in origin and odorless. Examples include soybean, peanut, olive, sesame and corn oils.
Dextrose 5% Water
Dextrose 10% water
Normal Saline (Sodium Chloride 0.9%)
1/2 NS
Half Normal Saline (Sodium Chloride 0.45%)
1/4 NS
One-quarter Normal Saline (Sodium Chloride 0.225%)
Sterile Water for Injection
Lactated Ringers