BP Testing Flashcards
Physical tests for tablets ?
- hardness
- friabilility
- general appearance
- disintegration
- uniformity of mass
Chemical tests for tablets?
- uniformity of content
- dissolution (rate drug dissolves)
- assay of active ingredients (exact quantity of active substances)
physical tests for capsules ?
-appearance
- disintegration
- uniformity of mass
chemical tests for capsules ?
- uniformity of content
- dissolution
- assay of active ingredients
what are common tablet defects ?
- capping = segments separate horizontally
- lamination = separates into layers
what are common capsule defects and a cause ?
- cracking
- pinhole
cause can be overfilling
what is friability of a tablet ?
% weight loss of powder from tablet surface due to mechanical action
procedure of friability test for uncoated tablets ?
- weigh tablet + place in drum
- rotate drum 100 times
- remove tablet
- wipe of any dust
- weigh
what is a remedy for friability ?
- stronger/ more binder
what is uniformity of weight ?
- weight consistency across tablets
procedure for testing uniformity of weight ?
- weigh 20 tablets individually
- calculate average mass
- pass if ‘ no more than 2 individual masses deviate from average by more than certain % and none deviates by double the %
How do tablets/capsules pass uniformity of weight test ?
- no more than 2 masses deviate from average by more than certain % and none deviates by double the %
- % found in BP
procedure testing for uniformity of weight in capsules ?
- weigh 20 capsules
- open capsule and empty contents
- for soft shell wash shell with solvent
- weigh empty shell
- mass = weight of filled - empty
- calculate average
procedure for testing uniformity of weight in powders ?
- remove label + wash + dry outside of container
- open container and weigh
- empty container and rinse with water then alcohol and dry
- weigh empty container
- calculate mass of contents
- repeat for all 20
what is uniformity of content ?
- checks active ingredient constant in each form