Parenteral Product Definitions

Front 1

Solute

Back 1

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

Front 2

Active ingredients

Back 2

drugs that exert a therapeutic effect

Front 3

Added Substances

Back 3

increase stability or usefulness of the parenteral product without causing harm or interfering with therapeutic efficacy.

Front 4

Antimicrobial Preservative

Back 4

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

Front 5

pH buffers

Back 5

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.

Front 6

Antioxidants

Back 6

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

Front 7

Drug Injection

Back 7

liquid preparations that are drug substances or solutions

Front 8

Drug For Injection

Back 8

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

Front 9

Drug Injectable Emulsion

Back 9

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

Front 10

Drug Injectable Suspension

Back 10

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

Front 11

Drug For Injectable Suspension

Back 11

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

Front 12

Container

Back 12

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.

Front 13

Single-dose container

Back 13

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.

Front 14

Multiple-dose container

Back 14

contain antimicrobial preservatives so that successive portions of the preparation can be withdrawn without changing the strength, quality or purity of the remaining portion.

Front 15

Glass

Back 15

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

Front 16

Plastic

Back 16

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

Front 17

Leaching

Back 17

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

Front 18

Sorption

Back 18

binding of molecules in the drug preparation to the polymer materials

Front 19

Solvent

Back 19

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

Front 20

Vehicle

Back 20

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

Front 21

Water For Injection, USP

Back 21

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

Front 22

Sterile Water for Injection, USP

Back 22

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.

Front 23

Bacteriostatic Water for Injection, USP

Back 23

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.”

Front 24

Sodium Chloride Injection, USP

Back 24

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

Front 25

Bacteriostatic Sodium Chloride Injection, USP

Back 25

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.

Front 26

Ringer's Injection, USP

Back 26

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

Front 27

Lactated Ringer’s Injection, USP

Back 27

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

Front 28

Water-Miscible Solvents

Back 28

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.

Front 29

Nonaqueous Vehicles

Back 29

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.

Front 30

D5W

Back 30

Dextrose 5% Water

Front 31

D10W

Back 31

Dextrose 10% water

Front 32

NS

Back 32

Normal Saline (Sodium Chloride 0.9%)

Front 33

1/2 NS

Back 33

Half Normal Saline (Sodium Chloride 0.45%)

Front 34

1/4 NS

Back 34

One-quarter Normal Saline (Sodium Chloride 0.225%)

Front 35

SWFI

Back 35

Sterile Water for Injection

Front 36

LR

Back 36

Lactated Ringers