Ceutics 3 Test 1

Question 1

Max amounts of Cationic Surface-Active Compounds

Answer 1

0.01%

Question 2

Max amounts of Chlorobutanol, Cresol, Phenol

Answer 2

0.5%

Question 3

Max amounts of Sulfer Dioxide, Sulfite, Bisulfite, Metabisulfite

Answer 3

0.2%

Question 4

Methods of Sterilization

Answer 4

Steam
Dry Heat
Filtration
Gas
Ionizing Radiation

Question 5

Absorption slow to fast

Answer 5

Oleaginous then Aqueous

Intradermal -> SubQ -> IM ->IV

Question 6

Solutes permeable to RBC membrane

Answer 6

Urea
NH4Cl
Alcohol
Boric Acid
Glycerin
Propylene Glycol

Question 7

Water Soluble Anti-Oxidants

Answer 7

Sodium Sulfite
Sodium Metabisulfite
Potasium Metabisulfite
Cysteine
Ascorbic Acid
Sodium Ascorbate

Question 8

Non-Aqueous Anti-Oxidants

Answer 8

Butylated Hydroxyanisole
Butylated Hydroxytoluene
Alpha Tocopherol

Question 9

Anti-Microbials

Answer 9

Benzyl Alcohol
Phenol
Parabens
Chlorobutanol
Benzalkonium Chloride (eye,nose,otic)

Question 10

Pyrogen Inactivation

Answer 10

Physical (detergent or WFI rinse)
Heat (250 C for 30 mins)
Chemical (HCl & NaOH, H2O2 or KMnO4)

Question 11

Depyrogenation

Answer 11

Distillation (WFI)
Ion Exchange (endotoxins are negatively charged)

Question 12

Sterility Testing

Answer 12

Direct Inoculation

Membrane Filtration

Question 13

Endotoxin Testing

Answer 13

Rabbit Test

Limulus Amoebocyte Lysate (LAL) test

Question 14

Labe Requirements

Answer 14

Name & Amount of all ingrediets
Total Volume
Route of Admin.
Storage
BUD
Other Info

Question 15

Mix order for TPN or TNA

Answer 15

Lipids
Amino Acids
Dextrosse

Question 16

Causes of Precipitation

Answer 16

Solvent Polarity Change
pH Change
Temp. Change
Formation of Insoluble Salts
Anions and Cations Complex

Question 17

Stable Calcium Salts

Answer 17

Gluconate and Acetate

Question 18

Filter size for TNA of lipids and non-lipid suspensions

Answer 18

1. 2 micron for lipid

0. 2 micron for non-lipid

Question 19

Low Risk

Answer 19

BUD: 48 hrs room temp, 14 Days refrig., 45 Days frozen

2 entries per container, 3 products

Question 20

Medium Risk

Answer 20

BUD: 30 hrs room temp, 9 Days refrig., 45 Days frozen

Complex Compounding

Question 21

High Risk

Answer 21

BUD: 24 hrs room temp, 3 Days refrig., 45 Days frozen

Non-sterile anything, must be sterilized before admin.

Question 22

Immediate Use

Answer 22

BUD: 1 hr from start of compounding
Non-hazardous drugs, 3 products, 2 entries
Emergency situations (ER, combat, cardiac arrest)

Question 23

Endotoxin Limit Formula

Answer 23

EL = K/M
5.0 EU/Kg/Hr or 0.2 EU/Kg/Hr if intrathecal
K : Threshold pathogen dose
M : Max Dose