This chapter provides quality attributes for products with approved labeling indicating that the tablets can be split to produce multiple portions that have an accurate fractional dose (labeled as functionally scored). The label claim of the split portions should be a simple fractional part of the claim for the intact tablet based on the number of scores and the size of the split portion (e.g., one-half, one-third, or one-quarter). At the time of splitting, the intact tablets should conform to the monograph specification. With the exception of dose, each split portion from tablets labeled as having a functional score are expected to conform to the quality attributes of the whole tablets. The split portions resulting from subdividing a functionally scored tablet should conform to the tests for Splitting Tablets with Functional Scoring and Dissolution or Disintegration given in this chapter.

This chapter applies to tablets labeled as having a functional score and to the split portions that represent any labeled fraction of the whole functionally scored tablet dose. Tablets should be split as part of the test procedure and the storage conditions for the split portions should be defined in the test procedure. For Dissolution or Disintegration testing, analysts should use only split portions from tablets determined to be acceptable by the Splitting Tablets with Functional Scoring test.

Use split portions from tablets that are acceptable according to the Splitting Tablets with Functional Scoring test.

Disintegration testing is necessary only when used as a surrogate for dissolution testing as specified in the monograph. Follow the procedure using split portions from tablets that are acceptable according to the Splitting Tablets with Functional Scoring test as the dosage unit (see Disintegration 701).