How many capsules should I take for content uniformity test?

Guidance such as United States Pharmacopeia (USP) <905> (1), European Pharmocopoeia (PhEur) 2.9. 40 (2), and other pharmacopeia chapters have set out the requirements for UDU by content uniformity testing. Generally, only 10 tablets from a batch have to be tested, Andrews notes.

What is content uniformity of tablet?

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 I check content uniformity of my tablet?

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.

What is the difference between weight variation and content uniformity?

Content Uniformity is the default test and may be applied in all cases. The test for Weight Variation is applicable for dosage forms specified as W1, W2, W3, and W4. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%.

How do you calculate AV for content uniformity?

1.1. Calculate the acceptance value by the formula: | M － X . | ＋ ks, in which the terms are as defined in Table 6.02-2.

What parameters can contribute to the lack of content uniformity in capsules?

Table 2

Sample number	Weight of half tablet (g)	85–115% of the average mass
21	0.05410	No
22	0.05800	Yes
23	0.07100	Yes
24	0.06500	Yes

What affects content uniformity of tablets?

In order to make satisfactory tablets by direct compression, especially when the API dose is low, it is necessary to understand the factors that contribute to achieving acceptable drug content uniformity. These may be summarised as drug particle size, mixing strategy and selection of key excipients (filler-binders).

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 limit of uniformity of content as per USP?

The requirements are met if not more than 1 unit of the 30 is outside the range of 85.0% to 115.0% of label claim, and no unit is outside the range of 75.0% to 125.0% of label claim and the RSD of the 30 dosage units does not exceed 7.8%.

Are coated tablets complying with content uniformity requirements?

Coated tablets are exempted from these requirements but must conform to the test for content uniformity. Uniformity of weight is a function of granulation quality, flow of granulation and machine performance. However, sometimes these ranges are not sufficiently narrow.

What is uniformity of content in drug testing?

Uniformity of Content. Content uniformity test was developed to ensure content consistency of active drug substances within a narrow range around the label claim in dosage units. This test is crucial for tablets having a drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total tablet weight.

What are the requirements for content uniformity?

Unless otherwise stated in the monograph, the requirements for content uniformity are met if the amount of active ingredient in nine (9) of the ten (10) tablets lies within the range of 85% to 115% of the label claim. The tenth tablet may not contain less than 75% or more than 125% of the labelled drug content.

What is the percentage of drug content in a tablet?

The tenth tablet may not contain less than 75% or more than 125% of the labelled drug content. If one or more dosage units do not meet these criteria, the remaining 20 tablets are assayed individually and none may fall outside of the 85% to 115% range for the batch to be accepted.