What is drug uniformity?
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 difference between content uniformity and weight variation?
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%.
What is 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.
How is content uniformity calculated?
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 weight uniformity test?
INTRODUCTION THE British Pharmacopaeia 1953 includes a test for the uniformity of weight of tablets which requires, that when the tablets in a sample of 20 are weighed singly, not more than 2 deviate from the average weight by a percentage greater than that specified and no tablet deviates by more than double that …
What is blend uniformity in pharma?
Abstract. 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.
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.
What is uniformity in statistics?
Uniformity Statistic: A Uniformity Statistic is a means of measuring the extent to which a sample conforms to a uniform distribution. • The Uniformity Statistics considered in our research produce lower values for samples that adhere more strongly to a uniform distribution.
How do you determine uniformity?
Calculate the average of all of the measurements (total average or AvgT). Divide the average of the lowest quartile (AvgLQ) by the total average (AvgT) to get distribution uniformity (DU).
What is the importance of uniformity of weight test in pharmacy?
Variation between tablet with respect to dose and weight must be reduced to a minimum. Uniformity of weight is an in process test parameter which ensures consistency of dosage units during compression. Weigh individually 20 units selected at random and calculate the average weight.
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.
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 is the uniformity of dosage units determined?
The uniformity of dosage units can be demonstrated by either of two methods, Content Uniformityor Weight Variation(see Table 1). 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.
How is the quality of a suppository checked?
Compounded suppositories can be checked for calculations of theoretical and actual weight and weight variation,color,hardness, surface texture, and overall appearance. Suppository quality control includes physi- cal and chemical aspects of the product (Box 9.1).
How is weight variation test used to measure content uniformity?
Other unit dose will need to undergo content uniformity (CU) test. In weight variation test, measurement of contents is done by estimation of contents based on weight. Pharmacists often use and misuse this WV test by doing this test on all dosage units. If it is used correctly, this WV test can be used to measure content uniformity (CU).
What does uniformity of weight of capsules mean?
From the results, all our capsules are having a deviation of ± 10%, which means that all capsules have uniform weights. This may indicate the uniformity of the capsules production. At the same time, this uniformity may also be caused by the usage of a good weighing balance.