[2] Stability, Adulteration, Heavy Metals

Extent to which a drug product retains, within specified limits, and throughout its period of storage and use, the same properties and chracteristics that it possessed at the time of its manufacture.

stability

period of storage and use

shelf life

date or time beyond which a compounded preparation must be discarded

beyond use date

Limits the time during which the conventionally manufactured product, active pharmaceutical ingredient (API), or excipient may be dispensed or used

expiration date

which of the ff factors does not affect product stability

darkness

which of the ff temp and RH does philippines belong to the international climatic zones?

30 degrees celcius, 70%

which of the climatic zone is japan classified?

II

solvolysis process in which drug molecules interact with water molecules to yield breakdown products

hydrolysis

which of the ff mechanism does reduction or elimination of water from pharmaceutical system belong to?

hydrolysis

which of the ff is classified as preventive measures of oxidation?

air replaced by an inert gas

it can be removed by purification or addition of enhancing agents (e.g. EDTA)

oxidation

setting the expiration date too early so that the product will be destroyed or recalled from the market earlier than necessary

alpha error

type 2 error in estimating expiration date can be

dangerous

30 degrees celcius

real time testing

6 months

accelerated testing

-20 degrees celcius

freezer: real time

intentional or deliberate type

sophistication

from olive oil to tea tree oil

sophistication

chinese star anis to japanese anis

substitution

addition of one article to another due to ignorance or carelessness or accident

admixture

replacement with substandard drug

inferiority

due to the attack of microorganism

spoilage

deliberate extraction of the constituents and the sale of the residue as the original drugs

deterioration