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level: QC2-Photostability testing.pptx

Questions and Answers List

Question	Answer
amount to which a drug substance or product reacts upon receiving photons, especially visible light.	Photosensitivity
stability of a drug substance or product on exposure to light.	Photostability
is a form of deliberately intense or thorough testing used to determine the stability of a given drug substance or product.	Stress testing
time period in which the drug product retains the same properties and characteristics that it possessed at the time of its manufacturing.	Stability
is that constituent of the packaging that is in direct contact with the drug substance or drug product, and includes any appropriate label.	Immediate (primary) pack
is the combination of immediate pack and other secondary packaging such as a carton.	Marketing pack
are those undertaken to degrade the sample deliberately.	Forced degradation testing studies
are those undertaken to establish photostability characteristics under standardized conditions.	Confirmatory studies
Q1A(R2) Stability Testing of New Drug Substances and Products.	Parent Guideline
may lead to under medication due to lowering of active drug concentration in dosage form.	Instability
leads to formation of toxic products.	Drug decomposition
Instability leads to	changes in physical appearance.