Up to the final Flashcards
(85 cards)
Beyond use date
used for compounded prescriptions
Expiration dates
used by pharmaceutical manufacturers
<795>
non sterile compounding
<797>
sterile compounding
<1178>
good repackaging practices
use suitable containers with an equivalent closure system
label has appropriate storage conditions and BUD
include lot number
<1191>
stability considerations in dispensing practice
Stability
capacity of a drug product to remain within specifications established to ensure its identity, strength, potency, quality and purity
Signs of lack of stability
change in performance or appearance
efficacy failure
Assay
strength
indicates the amount of API in dosage form
Does stability apply to homeopathic drugs, allergenic extracts, and new drugs for investigational use?
no
What from the environment affects stability?
pH, temp, light, oxygen, CO2
How do drugs and excipients affect stability?
particle size
relative purity of excipients
How does microbial contamination affect stability?
API, excipients, processing
Trace metals and catalysts can affect?
stability
How do closure systems affect stability?
moisture in containers
Chemical stability
each active ingredient retains its chemical integrity and labeled potency within the specified limits
Physical stability
the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained
Microbiological Stability
Sterility or resistance to microbial growing is retained according to the specified requirements; retain effectiveness within the specified limits
Therapeutic Stability
therapeutic effect remains unchanged within shelf life
Toxicological stability
no significant increase in toxicity occurs
Common pathways for chemical degradation
hydrolysis, oxidation, photodegradation, dehydration, isomerization, decarboxylation
For official compounded preparations, use ingredients that meet requirements of ?
compendial monograph
USP or NF grade or what substances should be used for preparations?
Analytical Reagents
Certified American Chemical Society
Food Chemical Codex
Manufactured containers are labeled with the expiration date and?
batch control number