How do you do the content uniformity test?
The test for uniformity of content of single-dose preparations is based on the assay of the individual contents of active substance(s) of a number of single-dose units to determine whether the individual contents are within limits set with reference to the average content of the sample.
How do you blend uniformity?
This method is used to demonstrate blend uniformity using dosage unit results. For example, a tablet with potency of 19.4 mg and weight of 98 mg = 19.4 ÷ 98 = 0.198 mg/mg. Label claim is 20 mg per each 100 mg tablet, so the weight corrected result is 0.198 ÷ 0.20 * 100 = 99% of target blend potency.
What is content uniformity as per USP?
To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim. The term “uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units.
What is the USP limit for tablet content uniformity?
CAPSULES, TRANSDERMAL SYSTEMS, INHALATIONS PACKAGED IN PREMETERED DOSAGE UNITS, AND MOLDED TABLETS — Unless otherwise specified in the individual monograph, the requirements for dosage uniformity are met if the amount of the active ingredient in not less than 9 of the 10 dosage units as determined from the Weight …
What is tablet content uniformity?
Uniformity of Content is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.
How do you calculate Av value in content uniformity?
Calculate the acceptance value (see Table 6.02-2.). Calculate the acceptance value by the formula: | M － X . | ＋ ks, in which the terms are as defined in Table 6.02-2.
What does AV mean in content uniformity?
Content Uniformity Calculate the acceptance value (see Table 6.02-2). (ii) Liquid or Semi-Solid dosage forms: Assay 10 units individually using an appropriate analytical method.