Health Pharmacy Question:
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WHAT IS FORCED DEGRADATION STUDY?
HOW TO PERFORM FORCED DEGRADATION ON TABLET SAMPLE OR SUSPENSIONS?
Answer:
under specificity forced degradation study is performed.
specificity is the ability to asses unequally the analyte in
the presence of components which may be expected to be present.
FORCED DEGRADATIION:
It is performed by following tests.
Heat:At about 105"c for about6 hours.
Humidity:About 90% RH at 25'c for not less than 7 days.
Uv light:Not less than 7 days in uv cabinet or 200 watt
hours or in photostablity chmber.
Sunlight:Not less than 55 hours in sunlight or 1.2million
lux hours in photostability chmber.
Acid:0.1 N HCL reflulxed for 30 minutes at 60"c.
Base:0.1N NAOH refluxed for 30 minutes at 60"c
Peroxide:1% H2O2 refluxed for 30 minutes at 60"c.
Water:refluxed for 6hours at 60"c
specificity is the ability to asses unequally the analyte in
the presence of components which may be expected to be present.
FORCED DEGRADATIION:
It is performed by following tests.
Heat:At about 105"c for about6 hours.
Humidity:About 90% RH at 25'c for not less than 7 days.
Uv light:Not less than 7 days in uv cabinet or 200 watt
hours or in photostablity chmber.
Sunlight:Not less than 55 hours in sunlight or 1.2million
lux hours in photostability chmber.
Acid:0.1 N HCL reflulxed for 30 minutes at 60"c.
Base:0.1N NAOH refluxed for 30 minutes at 60"c
Peroxide:1% H2O2 refluxed for 30 minutes at 60"c.
Water:refluxed for 6hours at 60"c
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