Summary
Summary Tablet specification
- Institution
- University Of East Anglia
Industrial pharmacy - 1st semester Includes bullet points, key diagrams and images
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Specification Is a statement about an attribute with which the product must comply with to be
approved for use
Tablet and Capsule
In BP Appendix XII
General specifications applicable to all products
Weight, uniformity, content uniformity and disintegration time
Process specifications
BP contains drug monographs and test conditions
Some tests are mandatory (some for specific formulations) and official but not
all
Tablet Specification Weight/Mass Uniformity
Official test
Applies to all tablet types
Assure all tablets are within similar weight limits
Assure all have the same amount of drug
Assure patient gets the same dose of drug
Assumes that drug distribution is even
Method: weigh 20 tablets individually from same batch and calculate mean
weight
No more than 2 can deviate from the mean by a set limit and none can be 2x the
limit
Tablet Specification Content
Unofficial
Applies to all tablets
Ensure average drug content is within set limits
Ensure patient gets the same dose each time
Method- assay 10 tablets from the same batch
Must be within 90-110% of stated dose
Tablet Specification Content Uniformity
Official
Applies to all tablets
Ensure each individual tablet has the correct stated dose
Ensure patient gets the same dose each time
Method- assay 10 tablets from the same batch and calculate mean drug content
Passes if all tablets are within 85-115% of the mean
If 1 tablet is outside of the 85-115% of the mean but within 75-125% then 20
more tablets must be tested. Calculate the mean for all 30 and then all 30 must
be within 85-115% of the new mean
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