Week 2

Question 1

Solute

Answer 1

chemicals substances dissolved in vehicles or solvents. They may be active ingredients or added substances

Question 2

Active Ingredients

Answer 2

drugs that exert a therapeutic effect

Question 3

Antimicrobial Preservative

Answer 3

an added substance used in liquid and semi-solid preparations to prevent growth of microorganisms. Examples include benzyl alcohol, parabens, benzalkonium chloride

Question 4

pH Buffers

Answer 4

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.

Question 5

Antioxidants

Answer 5

an added substance that inhibits oxidation of the active drug. Examples include sodium and potassium salts of sulfite, bisulfite and metasulfite ions.

Question 6

Drug Injection

Answer 6

liquid preparations that are drug substances or solutions

Question 7

Drug for Injection

Answer 7

dry solids that must be constituted or reconstituted with a suitable liquid vehicle to yield a drug injection solution (diluted needed)

Question 8

Drug Injectable Emulsion

Answer 8

liquid preparations in which drug substances are dissolved or dispersed in a suitable emulsion medium

Question 9

Drug Injectable Suspension

Answer 9

liquid preparation in which drug substances are suspended in a suitable liquid vehicle

Question 10

Drug for Injectable Suspension

Answer 10

dry solids that must be constituted or reconstituted with a suitable liquid medium to yield a drug injectable suspension

Question 11

Container

Answer 11

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.

Question 12

Single-Dose Container

Answer 12

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.

Question 13

Multiple-Dose Container

Answer 13

contain antimicrobial preservatives so that successive portions of the preparation can be withdrawn without changing the strength, quality or purity of the remaining portion.

Question 14

Glass

Answer 14

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

Question 15

Plastic

Answer 15

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

Question 16

Leaching

Answer 16

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

Question 17

Sorption

Answer 17

binding of molecules in the drug preparation to the polymer materials

Question 18

Solvent

Answer 18

an agent used to dissolve a pharmaceutic substance or drug in the preparation of a solution; it must be aqueous or nonaqueous

Question 19

Vehicle

Answer 19

solvent or medium for liquid sterile products (a carrying agent for a drug substance), they have no therapeutic activity or toxicity

Question 20

Water for Injection, USP

Answer 20

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.

Question 21

Sterile Water for Injection, USP

Answer 21

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.

Question 22

Bacteriostatic Water for Injection, USP

Answer 22

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 is used in parenterals administered in small volumes (generally 5 mL or less) as the presence of excessive amounts of antimicrobial agents may be toxic. For this reason, USP labeling requirements demand that the label state, “Not for Use in Newborns.”

Question 23

Sodium Chloride Injection, USP

Answer 23

sterile isotonic solution of sodium chloride in Water for Injection (154 mEq of sodium and chloride ions per liter).

Question 24

Bacteriostatic Sodium Chloride Injection, USP

Answer 24

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.

Question 25

Ringer’s Injection, USP

Answer 25

sterile solution of sodium chloride, potassium chloride and calcium chloride (in concentrations similar to physiologic fluids) in Water for Injection.

Question 26

Lactated Ringer’s Injection, USP

Answer 26

contains the same three salts as Ringer’s Injection in different quantities and also contains sodium lactate.

Question 27

Water-Miscible Solvents

Answer 27

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.

Question 28

Nonaqueous Vehicles

Answer 28

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.

Question 29

D5W

Answer 29

Dextrose 5% Water

Question 30

D10W

Answer 30

Dextrose 10% water

Question 31

NS

Answer 31

Normal Saline (Sodium Chloride 0.9%)

Question 32

½ NS

Answer 32

Half Normal Saline (Sodium Chloride 0.45%)

Question 33

¼ NS

Answer 33

One-quarter Normal Saline (Sodium Chloride 0.225%)

Question 34

SWFI

Answer 34

Sterile Water for Injection

Question 35

LR

Answer 35

Lactated Ringers