What is BU in pharmaceutical?

What is BU in pharmaceutical?

Blend Uniformity and Content Uniformity (BUCU) FAQs | ISPE | International Society for Pharmaceutical Engineering.

What is CU in pharmaceutical industry?

Background. The USP <905> content uniformity (CU) test methodology for batch release includes testing of individual doses of finished pharmaceuticals to ensure that the product meets quality specifications.

What is the content uniformity test?

Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.

What is stratified CU?

Stratified sampling is the process of selecting units deliberately from various locations within a lot or batch or from various phases or periods of a process to obtain a sample.

How is content uniformity measured?

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 content uniformity as per USP?

The test for Content Uniformity is based on the assay of the individual content of drug substance(s) in a. number of individual dosage units to determine whether the individual content is within the limits set. The Content. Uniformity method may be applied in all cases.

How is content uniformity performed?

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.

What is L1 and L2 in content uniformity?

L1 is used as the limit for the acceptance value for both stages of test. L2 is used only in the second stage of testing where a total of 30 dosage units have been tested, and it is only used in the calculation of the allowed limits for individual dosage unit content.

Why is Content Uniformity important?

Content uniformity is an important quality measure of the final solid dosage product, notes Ian Robertson, spectroscopy applications specialist at PerkinElmer. It ensures that a consistent dose of the API is maintained between batches so that the patient receives the correct dose.

How is Content Uniformity calculated?

Criteria The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to L1% and no individual content of the dosage unit is less than (1－ L2 × 0.01)M nor more than (1 ＋ L2 × 0.01)M in Calculation of Acceptance Value under Content Uniformity or under Mass Variation.

Why blend uniformity test is performed?

Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue. The particle size of the formulation ingredients can affect the physical properties of the product.

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.