Revised Parenteral

Question 1

What are Single Dose Containers?

Answer 1

vials or ampules

Question 2

What do Single Dose Containers not contain?

Answer 2

preservatives

Question 3

What do Multiple Dose Containers require?

Answer 3

a bacteriostatic chemical/preservative

Question 4

What are 2 examples of bacteriostatic chemical/preservative?

Answer 4

benzyl alcohol or methyl paraben

Question 5

What do rubber Closures need to be compatible with?

Answer 5

the solution

Question 6

What are the 6 COMMON EXCIPIENTS USED for parental solutions?

Answer 6

1. ANTIOXIDANT
2. CHELEATING AGENT
3. BUFFER
4. SOLVENT
5. OSMOTIC AGENT
6. SOLUBILIZING AGENT

Question 7

What is an example of an ANTIOXIDANT EXCIPIENT USED for parental solutions?

Answer 7

ASCORBIC ACID

Question 8

What is an example of a CHELEATING AGENT EXCIPIENT USED for parental solutions?

Answer 8

EDTA

Question 9

What is an example of a BUFFER EXCIPIENT USED for parental solutions?

Answer 9

SODIUM PHOSPHATE

Question 10

What are 3 examples of a SOLVENT EXCIPIENT USED for parental solutions?

Answer 10

WATER, SESAME OIL, ALCOHOL

Question 11

What is an example of an OSMOTIC AGENT EXCIPIENT USED for parental solutions?

Answer 11

SODIUM CHLORIDE

Question 12

What is an example of a SOLUBILIZING AGENT EXCIPIENT USED for parental solutions?

Answer 12

POLYSORBATE 80

Question 13

What are the 4 Quality Standards & Requirements for injections?

Answer 13

Sterile, Pyrogens or bacterial endotoxins limit, Label, Added Substances

Question 14

What do labels of injections list? (3)

Answer 14

Lists names and amounts of all ingredients, and permits viewing container contents.

Question 15

What are the Added Substances for injections?

Answer 15

Antimicrobial preservatives; GRAS solvents, pH buffers, tonicity agents, stabilizers, antioxidants.

Question 16

What is prohibited in Added Substances for injections?

Answer 16

Colorings.

Question 17

What must the Pyrogens or bacterial endotoxins limit meet for injections?

Answer 17

Monograph standard.

Question 18

What are the 3 Sterility Testing of Product for injections?

Answer 18

Rabbit pyrogen test, Limulus Amebocyte Lysate (LAL) test, Bacterial Endotoxins Test USP

Question 19

In the Bacterial Endotoxins Test USP, what are endotoxins?

Answer 19

A layer of lipopolysaccharides from gram negative bacteria

Question 20

Is Bacterial Endotoxins Test USP very difficult to remove with filtration or heat?

Answer 20

Yes

Question 21

What is the goal of Bacterial Endotoxins Test USP?

Answer 21

To prevent introduction of bacterial endotoxins in the preparation

Question 22

Can some endotoxins be tolerated?

Answer 22

Yes

Question 23

What is the Limulus Amebocyte Lysate (LAL) test based on?

Answer 23

An enzyme from the horseshoe crab’s blood cells that coagulate in the presence of endotoxins.

Question 24

Which Sterility Testing of Product for injections is most commonly used today?

Answer 24

Limulus Amebocyte Lysate (LAL) test

Question 25

What is the Rabbit pyrogen test?

Answer 25

The drug is injected into a lab rabbit and if their temperature increases, it is considered positive for the endotoxins.

Question 26

What is the USP definition of injection?

Answer 26

Injection - Liquid drugs or solutions

Question 27

What is the USP definition of for injection?

Answer 27

For injection - Dry solids powders reconstituted with suitable vehicles into liquids for injection

Question 28

What is the USP definition of injectable emulsion?

Answer 28

Injectable emulsion - Liquid prep of drug dissolved in emulsion medium ## Footnote Example: Propofol

Question 29

What is the USP definition of injectable suspension?

Answer 29

Injectable suspension - Liquid prep of solids suspended in liquid ## Footnote Example: Methylprednisolone

Question 30

What is the USP definition of for injectable suspension?

Answer 30

For injectable suspension - Dry solid when reconstituted becomes a suspension ## Footnote Example: Imipenem and Cilastatin