Part 3: Other QC Procedures

Question 1

sterile rp

Answer 1

contains no living organisms

Question 2

apyrogenic rp

Answer 2

contains no metabolic by-products of microorganisms

Question 3

pyrogens cause _____ and ______.

Answer 3

fevers, chills

Question 4

what is the USP sterility test?

Answer 4

• put together the kits used over a period of time and allow it to decay
• sample is placed into two different growth media
• incubate for 14 days and check periodically for growth

Question 5

growth mediums used:
1) fluid thioglycolate for ______
2) soybean-casein digest medium for ______ and ______.

Answer 5

1) bacteria
2) fungi and molds

Question 6

two methods for pyrogen testing

Answer 6

1) USP rabbit test
2) bacterial endotoxin test (BET)

Question 7

describe the USP rabbit test

Answer 7

rabbits injected with rp and checked for increase in temperature
(significant changes = presence of pyrogens)

Question 8

describe the BET test

Answer 8

use of purified protein obtained from the blood of horseshoe crab
blood forms opaque gel in the presence of pyrogens
spectrophotometer is used to see how much light will pass through the sample

Question 9

which pyrogen testing is simpler, easier, faster, cheaper and more sensitive?

Answer 9

BET test

Question 10

LAL

Answer 10

limulus amebocyte lysate (protein in BET test)

Question 11

what are the QC objectives that are also considered by the manufacturer?

Answer 11

1. method of testing and maintenance of RP stability
2. methods and rationale for RP toxicity testing
3. common adverse reactions to RP

Question 12

stability

Answer 12

shelf-life of the RP; how long will the labelled RP remains in its desired form

Question 13

what influences stability?

Answer 13

• radiolysis
• type/strength of bonding
• additives and other ingredients in kit
• which containers they are stored in

Question 14

toxicity

Answer 14

ability of the compound to cause illness or death

Question 15

which portion of the RP is of concern for toxicity?

Answer 15

pharm portion

Question 16

in terms of stability, what must the manufacturer determine?

Answer 16

• optimum shelf-life
• which storage container to use
• what reagents to use (buffers, acids, bases, antioxidants)

Question 17

in terms of toxicity, what must the manufacturer determine?

Answer 17

• toxic effects?
• safe dosage?
• safety factors?
• what happens in an overdose?

Question 18

acute systemic toxicity

Answer 18

effects that occur after a single high dose

Question 19

repeated dose/organ toxicity

Answer 19

effects occurring after chronic dose administration

Question 20

TD

Answer 20

toxic dose

Question 21

LD

Answer 21

lethal dose

Question 22

LD50

Answer 22

dose produces death in 50% of the specimens

Question 23

TD50

Answer 23

dose that produces toxicity in 50% of the specimens

Question 24

LD50/30

Answer 24

dose produces death in 50% of the specimens in 30 days

Question 25

TD50/30

Answer 25

dose that produces toxicity in 50% of the specimens in 30 days

Question 26

safety factor

Answer 26

difference between toxic dose and therapeutic dose administered to patients
(toxic dose/therapeutic dose)

Question 27

adverse reaction

Answer 27

harmful, unintended or unusual effect associated with the admin of the RP

Question 28

what portion of the RP is of concern for adverse reactions?

Answer 28

pharm portion

Question 29

is an overdose an adverse reaction?

Answer 29

no.
it is a tech’s error

Question 30

is the result of a poor injection technique an adverse reaction?

Answer 30

no
it is a tech’s error