How do you calculate blended 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 the limit for blend uniformity?
The statistical tolerance limits are constrained within 85.0% and 115.0% of blend uniformity, meaning that there is a 95% chance that a minimum of 90% of the blend is within 85.0% and 115.0% (see Fig. 1).
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).
What is blend uniformity analysis?
Blend uniformity analysis (BUA) is a routine and highly regulated aspect of pharmaceutical production. In most instances, it involves quantitative determination of individual components of a blend in order to ascertain the mixture ratio.
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 |
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%.
What is BU sampling in pharma?
BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. Definition. Blend Uniformity (in accordance with FDA Guidance for Industry, ANDAs: Blend Uniformity Analysis, 1999) In-Process Control.
Why blend uniformity test is performed?
BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product.
What is the difference between assay and blend 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.
What is L1 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.
How many dosage units should be collected during blend uniformity sampling?
In exhibit batch Blend uniformity sampling and during compression/filling stratified in-process dosage unit sampling shall be performed. Stratified in-process dosage unit sampling shall be done as explained below. During compression 7 dosage units each from 20 locations shall be collected during the entire compression run.
When are additional blend and content uniformity samples required for process verification?
Additional blend and content uniformity samples may be required for Stage 3A: Process Verification, depending on the results process knowledge obtained during Stage 1 and Stage 2 testing. The sampling plans presented are meant to be examples. Alternative sampling plans may be used.
What is the use of blend uniformity?
Blend uniformity. BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. BUA or homogeneity testing can be applied to all dosage forms, but is recommended for those dosage forms for which the USP requires content uniformity testing.
What to do if blend uniformity fails during trial batches?
During trial batches, Blend Uniformity shall be done. If blend uniformity fails then a stratified sampling of finished product shall be done and Uniformity of dosage unit test shall be performed. Stratified In-process dosage unit sampling shall be done.