2091 WEIGHT VARIATION OF DIETARY SUPPLEMENTS
The following tests provide limits for the permissible variations in the weights of individual tablets or capsules, expressed in terms of the allowable deviation from the average weight of a sample. Separate procedures and limits are described herein for capsules, uncoated tablets, and coated tablets that are intended for use as dietary supplements.
Capsules meet the requirements of the following test with respect to variation in weight of contents.
Weigh 20 intact capsules individually, and determine the average weight. The requirements are met if each of the individual weights is within the limits of 90% and 110% of the average weight.
If not all of the capsules fall within the aforementioned limits, weigh the 20 capsules individually, taking care to preserve the identity of each capsule, and remove the contents of each capsule with the aid of a small brush or pledget of cotton. Weigh the emptied shells individually, and calculate for each capsule the net weight of its contents by subtracting the weight of the shell from the respective gross weight. Determine the average net content from the sum of the individual net weights. Then determine the difference between each individual net content and the average net content: the requirements are met if (a) not more than 2 of the differences are greater than 10% of the average net content and (b) in no case is the difference greater than 25%.
If more than 2 but not more than 6 capsules deviate from the average between 10% and 25%, determine the net contents of an additional 40 capsules, and determine the average content of the entire 60 capsules. Determine the 60 deviations from the new average: the requirements are met if (a) in not more than 6 of the 60 capsules does the difference exceed 10% of the average net content and (b) in no case does the difference exceed 25%.
Proceed as directed under Hard Capsules, but determine the net weight of the contents of individual capsules as follows. Weigh the intact capsules individually to obtain their gross weights, taking care to preserve the identity of each capsule. Then cut open the capsules by means of a suitable clean, dry cutting instrument, such as scissors or a sharp open blade, and remove the contents by washing with a suitable solvent. Allow the occluded solvent to evaporate from the shells at room temperature over a period of about 30 minutes, taking precautions to avoid uptake or loss of moisture. Weigh the individual shells, and calculate the net contents. The requirements are as stated under Hard Capsules.
Tablets conform to the criteria given in the accompanying table.
Uncoated Tablets and Film-Coated Tablets
Weigh individually 20 whole tablets, and calculate the average weight. The requirements are met if the weights of not more than 2 of the tablets differ from the average weight by more than the percentage listed in the accompanying table and no tablet differs in weight by more than double that percentage.
Coated Tablets (Other Than Film-Coated Tablets)
Weigh individually 20 whole tablets, and calculate the average weight. If the coated tablets do not conform to the criteria in the accompanying table, place 20 tablets in a beaker of water at 37, and swirl gently for not more than 5 minutes. Examine the cores for evidence of disintegration and repeat the procedure for a shorter time if disintegration has begun. Dry the cores at 50 for 30 minutes. Accurately weigh 20 individual tablet cores, and calculate the average weight.
The requirements are met if the weights of not more than 2 of the tablets differ from the average weight by more than the percentage listed in the accompanying table and no tablet differs in weight by more than double that percentage.
Weight Variation Tolerances for Uncoated Tablets, Film-Coated Tablets, and Coated Tablets (Other Than Film-Coated Tablets)
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 978Pharmacopeial Forum: Volume No. 28(5) Page 1548