What is the limit for content uniformity test?

What is the limit for content uniformity test?

The preparation complies with the test if each individual content is 85 to 115 percent of the average content. The preparation fails to comply with the test if more than one individual content is outside these limits or if one individual content is outside the limits of 75 to 125 percent of the average content.

What is the uniformity of content 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 the 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%. 1.

How is content uniformity calculated?

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.

What affects content uniformity?

With this device, final content uniformity is influenced by the ratio of constituents and the active ingredient, electrostatic charge, particle density, shape and size. Significant proce- dural parameters include the mixing order of individual components, mixing time and speed, container shape and container load (20).

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.

How do you calculate uniformity weight?

Then, tablets was weighed individually and for each tablet, the percentage of deviation of its weight from the average weight was determined….Capsule.

Average Net Weight of Capsule Deviation (%) Number Of Tablets
Less than 300 mg ±10.0 ±20.0 Minimum 18 Maximum 2
300 mg or more ±7.5 ±15.0 Minimum 18 Maximum 2

How many tables are required for content uniformity test?

Two Acceptance Limit Tables based on a 50% confidence level for sample sizes of 10 & 30. Sampling Plan 2 tables with a 90% confidence level are provided for three sampling plans: 20×3, 20×7, and 40×3 (# locations x # tested per location).

How can the blend of uniformity be improved?

Dry coating using high-intensity vibratory mixing is employed to reduce API cohesion and granular Bond number as well as agglomeration as predicted by contact models, hence improve blend content uniformity (CU).

How do you test blend uniformity?

Why is blend uniformity important?

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. No method is developed yet to determine the uniformity of blend during the mixing.

What is RSD in blend uniformity?

The Acceptance criteria of Blend Uniformity Analysis is as follows, • RSD (relative standard deviation) of all individual results ≤ 5.0 percent. • All individual results are within 10.0 percent (absolute) of the mean of the results (90% to 110% of added amount of active drug substance- API).

How do you calculate blended uniformity?

What is the difference between uniformity of content and content uniformity?

The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously. Furthermore, the evaluation procedure of content uniformity tests is the same for all units.