Content Uniformity.docx

CONTENT UNIFORMITY ABSTRACT The uniformity of dosage unit specification is not intended to apply to suspensions, emulsions, or gels in unit-dose containers intended for topical administration. The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units. Therefore, the requirements of this chapter apply to each drug substance being comprised in dosage units containing one or more drug substances, unless otherwise specified in the individual monograph. The uniformity of dosage units can be demonstrated by either of two methods, Content Uniformity or Weight Variation. The content uniformity can be performed by weight individually 20 tablets. Then, the average weight is calculated by adding weight of all individual 20 tablets divided by the number of the tablet. The individual weight are then comparing to the average weight. The requirement are met because the weighs of not more than 2 of the tablets differ in weight by more than the percentage listed. The result showed no tablet differ in weight by more than double that percentage. The experiment passed. The uniformity of diameter of the tablets can be further proven with the percentage difference that has been calculated. Theoretically, tablets with diameter 12.5 mm or more than 12.5 mm would have not more than 3% of individual deviation from the average diameter. From the results obtained, it showed that all the tablets have achieved percentage difference below than 3%. This means that each tablets had obey the theoretical value of standard diameter.

OBJECTIVE To determine the uniformity of weight of tablets and capsules.