exam 2 Flashcards
How should USP chapter >1000 be treated?
Recommendation
How should USP chapter <1000 be treated?
Enforceable- “minimum requirement”
Which USP chapter involves pharmaceutical compounding- sterile preparations?
USP <797>
Which USP chapter involves handling hazardous drugs in healthcare settings?
USP <800>
Taken into the body or administered in a manner other than through the digestive tract, as by intravenous or intramuscular injection
parenteral
What are parenteral requirements? (SPP)
Sterile, particle free, and pyrogen free
Match with sterile/non-sterile and hazardous/non-hazardous
USP <797> , USP <800>
USP <797>: Sterile, hazardous and non-hazardous
USP <800>: Sterile and non-sterile, hazardous
T/F: Sterilization eliminates pyrogens
False
An acute reaction to bacterial endotoxins is (speticemia/septic shock) while infection of the blood is (speticemia/septic shock)
septic shock, speticemia
What is the difference between [DRUG] injection vs [DRUG] for Injection
Injection- liquid preparation
FOR injection- not for use ‘as is’ needs reconstitution for prepared soln
What size (mL) range small vs large volume parenteral?
Small- 100mL or less
Large- >100mL
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, non-sterile, single use sealed container
water for injection (WFI)
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile, packed in sealed containers not larger than 1000 mL
Sterile water for injection USP (SWFI)
Which type of water (WFI, SWFI, or BWFI):
Pyrogen free, sterile with antimicrobial agent added
Bacteriostatic Water for Injection USP (BWFI)
T/F: SWFI can be injected directly into the blood stream
False- would cause hemolysis
Which criteria apply to USP <800>?
A. Informational
B. Mandatory
C. Injectable only
D. Injectable and non-injectable
B. Mandatory
D. Injectable and non-injectable
A product used during preparation has an expiration date of 3/5/2026. Would this be used as the final products expiration date?
No! Would need a new beyond use date (BUD)
What are the two “least forgiving” parenteral routes of administration?
IV and intraspinal
T/F: Intra-spinal injections contain preservatives
FALSE
Which solution is more desirable for parenteral administration?
Hypotonic or hypertonic?
Hypertonic. Hypotonic can cause hemolysis
What are aqueous isotonic vehicles?
A. 5% Dextrose in normal saline
B. 5% Dextrose in water
C. 2.5% Dextrose in half normal saline
D. 2.5% in water
E. Sterile Water for Injection (SWFI)
F. Normal Saline
G. Bacteriostatic Sterile Water for Injection
B. 5% Dextrose in water
C. 2.5% Dextrose in half normal saline
F. Normal Saline
Which are water miscible solvents (cosolvents)?
A. Ethyl alcohol
B. Benzyl alcohol
C. Ringer’s solution
D. Polyethylene glycol (PEG)
E. Propylene glycol (PG)
A. Ethyl alcohol
D. Polyethylene glycol (PEG)
E. Propylene glycol (PG)
What is the benefits with PEG in IV concentrations?
Mild on cells: can be as high as 40% (v/v)
Which type of oil solution is OK for IV injection?
Emulsion or Solution?
Emulsion
For IM injection, solutions are okay