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level: Level 3

Questions and Answers List

level questions: Level 3

Question	Answer
LIGHT SOURCES OPTION	Option 1 Option 2
Any light source that is designed to produce an output similar to the D65/ID65*	Option 1
Similar sample should be exposed to both the cool white fluorescent and near ultraviolet lamp.	Option 2
1 daylight fluorescent lamp 2 xenon 3 metal halide lamp. what option?	Option 1
1 cool white fluorescent lamp 2 near UV fluorescent lamp what option?	Option 2
Samples should be exposed to light providing illumination of not less than __ AND an integrated near ultraviolet energy of not less than __	1.2 million lux hours, 200 watt hours/square meter
Samples may be exposed side-by-side with a validated chemical __	actinometric system.
is to evaluate the overall photosensitivity of the material for method development purposes and/or degradation pathway elucidation.	Forced degradation testing studies:
DRUG SUBSTANCE Consist of two parts:	1 Forced degradation testing 2 Confirmatory testing
1 samples should be in chemically __ and __containers. 2 variety of exposure conditions may be used: __	1 inert, transparent 2 photosensitivity of drug substance and intensity of light source
provide the information necessary for handling, packaging, and labeling.	Confirmatory studies:
Solid drug substances spread across the container to give a thickness of not more than __	3 millimeters.
Liquids should be exposed in chemically __ containers.	inert and transparent
DRUG SUBSTANCE: JUDGEMENT OF RESULTS, It is important to recognize that they form part of the stress testing and are not therefore designed to establish qualitative or quantitative limits for change.	Forced degradation studies:
DRUG SUBSTANCE: JUDGEMENT OF RESULTS, should identify precautionary measures needed In manufacturing or in formulation of the drug product, and If light resistant packaging is needed.	Confirmatory studies:
If the drug is clearly photostable or photolabile the photostability is confirmed on a	single batch.
Studies should be carried out in a sequential manner.	1 fully exposed product 2 in immediate pack 3 in marketing pack
If the results of the confirmatory study are EQUIVOCAL, testing of up to __ additional batches should be conducted.	two
1 The samples should be positioned to provide __ area of exposure to the light source. 2 If direct exposure is not practical (e.g., due to oxidation of a product), the sample should be placed in a suitable __	1 maximum 2 protective inert transparent container
If testing of the drug product in the immediate container or as marketed is needed	TRUE
the samples should be placed __ with respect to the light source, whichever provides for the most uniform exposure of the samples.	horizontally or transversely