Summary:
Size, Shape, and other Physical Attributes of Generic Tablets and Capsules As per USFDA
| RLD Size & Shape | ANDA Sample (Test Sample) |
| If the RLD is less than 17 mm in its largest dimension | No more than 20 percent larger than the RLD in any single dimension (the resulting single dimension of the generic should not exceed 17 mm) No more than 40 % larger than the volume of the RLD |
| If the RLD is equal to or greater than 17 mm in its largest dimension | No larger than the RLD in any single dimension. No larger than the volume of the RLD |
| USFDA recommends that the largest dimension of a tablet or capsule should not exceed 22 mm and that capsules should not exceed a standard 00 size. | NA |
| Additional flexibility may be given for products that are 8 mm or smaller in their largest dimension | NA |
| RLD capsule is of size 3 or smaller | Allow an increase of one capsule size |
| When the RLD capsule is of size 2 or larger, | An increase of one capsule size should only be considered when adequate justification can be provided for the size increase. These recommendations would allow an increase of one capsule size when the capsule size is less than capsule size 00. |
| RLD capsule is of size 3 or smaller | It will allowed an increase of one capsule size |
| RLD capsule is of size 2 or Large | Increase of one capsule size should only be allowed when adequate justification can be described for the size increase. These recommendations would permitted an increase of one capsule size when the capsule size is less than capsule size 00 |
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Tablet Scoring or Splitability study or Breakability Test
Reference:
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules by USFDA
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