Powders 10 Flashcards
What tests are performed
uniformity of content uniformity of mass friability resistance to crushing disintegration dissolution appearance test
what is the aim of the uniformity of content
ensure the variation in each dose of your formulation is within the acceptable limits
where can you find the acceptable limits for the uniformity of content
you can look up the exact api in the bp to see the limits
what is the uniformity of weight test
weigh individually 20 units taken at random or for single dose preparations presented in individual containers. then take the average mass
what are the acceptable limits for the uniformity of weight test
no more than 2 of the masses deviated from the average mass by more than the percentage deviation and none devited by more than twice that percentage
what is the friability test
tablets are placed into a drum and rotated. weighing them before and after to see if there is a difference
what is the acceptable limit of the friability test
bp states that los within 1% is accpetable
what is a bp test but is not required or the tablet to be released to market
resistance to crushing test
