Nuclear Pharmacy Qc

Front 1

When are RP QC tests performed? 3 times

Back 1

After RP produced, After RP is eluted from generator, after RP kit is made.

Front 2

2 types of QC test

Back 2

1. Physiochemical 2. Biologic

Front 3

What does physiochemical QC test check for? 2 things

Back 3

1. Purity/integrity
2. Physical/chemical properties

Front 4

6 physiochemical properties

Back 4

physical properties
pH
Ionic strength
Nuclide purity
Chemical purity
Radiochemical purity

Front 5

Physical properties test include 2 things

Back 5

Color & state of RP
Size & # of particles

Front 6

Color/state of chemicals-normal

Back 6

clear, no clumps

Front 7

Size of MAA particles

Back 7

10-90um, no greater than 150um

Front 8

Size of Sulfer Colloid particles

Back 8

0.1-1um

Front 9

# of MAA particles/ugAA

Back 9

1-16 million/ug/AA

Front 10

How many MAA particles in a dose

Back 10

200k-400K, min 100k

Front 11

Test for particle size called

Back 11

Hemocytometer

Front 12

Blood pH

Back 12

7.35-7.45- slightly basic

Front 13

2 ways to test for pH

Back 13

paper, meter

Front 14

ionic strength is?

Back 14

bond b/w pharmaceutical and RN
relates to free Tc

Front 15

Radionuclide purity is?

Back 15

Rn you expect is what you get, fraction of RA present in desired form

Front 16

What is a test for RN impurities?

Back 16

Lead shield method, sheild stops all Tc energy and measure what escapes

Front 17

How often should lead shield method be performed?

Back 17

after every elution

Front 18

Max Moly breathrough allowed?

Back 18

0.15uci 99Mo/mciTc99m

Front 19

What is a chemical purity test for?

Back 19

Alumina breathrough

Front 20

max allowable alumina breathrough?

Back 20

10 ug/Al/mLTc99m

Front 21

If alumina test strip is darker than standard what is the result of the test?

Back 21

outside limits, through out elution

Front 22

Radionuclidic impurity max allowable?

Back 22

0.5uci impurity/mciTc99m

Front 23

how often is alumina breathrough tested?

Back 23

on every Sodium pertechnetate solution

Front 24

8 ways to test radiochemical purity?

Back 24

precipitation, paper and ITLC, gel chromatography, paper or gel electrophoresis, ion exchange, solvent extraction, HPLC, distillation.

Front 25

Which radiochemical purity test is most used?

Back 25

HPLC- high pressure liquid chromatography

Front 26

4 causes of RC impurities?

Back 26

1.change in temp or pH
2.Light
3.oxidizing & reducing agents
4.radiolysis

Front 27

2 effects of RC impurities

Back 27

1.increased exposure to pt
2.decreased target:non-target ratio

Front 28

3 biologic tests

Back 28

1. sterility
2. pyrogenicity
3. toxicity

Front 29

What is pyrogenicity?

Back 29

Result of metabolic byproducts (endotoxins) of microorganisms

Front 30

What agency requires RP's be biologically safe?

Back 30

FDA for IV administration

Front 31

2 methods of sterilization

Back 31

1. Autoclave
2. Filtration- .45um most common, .22um for blood

Front 32

3 tests for sterility

Back 32

1.Fluid thyoglycolate medium, 2.Soybean casein digest,
3.14C glucose test

Front 33

2 test for pyrogenicity

Back 33

1. LAL- limbulus amebocyte lysate test (horshoecrab)
2.Rabbit test (3 used)

Front 34

2 tests for toxicity

Back 34

1. Animal
2. Computer models & cell culture-preferred method

Front 35

LD 50/60 means?

Back 35

lethal dose produce 50%death in 60 days-safe for humans

Front 36

4 types of chemical bonds

Back 36

1. ionic
2. covalent
3. Coordinate covalent
4. chelation

Front 37

ionic bond is?

Back 37

attracted to each other and bond

Front 38

covalent bond is?

Back 38

2 atoms dontate and outer shell electron

Front 39

Coordinate covalent bond is?

Back 39

1 atom donates an electron

Front 40

Chelation is?

Back 40

multiple coordinate covalent bonds

Front 41

4 methods of radiolabeling

Back 41

1. isotope exchange reaction
2. introduction of foreign label
3. Bifunctional chelating agents
4. Biosynthesis

Front 42

isotope exchange reaction

Back 42

1+ atoms replaced by isotope of same element w. different mass# (A#)

Front 43

examples of isotope exchange raction

Back 43

I-125 labeled T3

Front 44

Foreign label

Back 44

RA added to molecule w/ known biologic role and RN forms a bond

Front 45

Examples of foreign label

Back 45

99mTc RP's, 111In-WBC

Front 46

Bifunctional chelating agents

Back 46

2 chelating bonds formed by molecule

Front 47

example bifunctional chelating agents

Back 47

99mTc-Antibody-DTPA=
RN-macromolecule-molecule

Front 48

Biosynthesis

Back 48

organism grown in culture containing and RA tracer

Front 49

example of biosynthesis

Back 49

57Co-cyanobalamin (b-12)

Front 50

8 factors in radiolabeling

Back 50

1. efficiency, 2. stability 3. denaturation, 4. isotope effect, 5. storage, 6. radiolysis, 7. shelf life, 8. purification

Front 51

efficiency

Back 51

amt of pharm that labels to RN

Front 52

stability

Back 52

bond strength

Front 53

Are covalent & coordinate covalent bonds strong or weak?

Back 53

Strong

Front 54

radiolysis

Back 54

radioactivity of RN breaks down bond

Front 55

Max shelf life, Tc specifically

Back 55

3 physical t1/2's or 6 months
Tc-RP's max is 18 hrs

Front 56

Minimum shelf life

Back 56

1.5 x length of study

Front 57

Lypholized means?

Back 57

freeze dried

Front 58

what is in a lypholized kit disk?

Back 58

1mg pharmaceutal
0.5mg reducing agent
0.5mg additives
pH adjuster

Front 59

Name some additives & preservatives

Back 59

ascorbic acid, gentisic acid, acetates, cirtrates, benzyl alcohol

Front 60

Proper method prepare RP kit

Back 60

swab RP vial, inject amt of RN in vial, mix pharmaceutical, assay vial and colete label, possibly need to incubate vial