What is the uniformity of weight 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 …
How many capsule are used for uniformity of weight?
For capsules Weigh the shell. The difference between the weighings gives the weight of the contents. Repeat the procedure with another 19 capsules.
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 capsule content uniformity?
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.
Why is uniformity of weight important in tablets?
Weight uniformity of tablet halves cannot be relied upon to achieve equal doses of drug in the resultant splits when the tablets contain low amount of potent active ingredient (PAI) such as the case of potent drugs.
Why is uniformity of content important?
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 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.
How many capsules are used for uniformity of weight evolution of capsule as per IP?
19 capsules
Weigh the shell. The weight of the contents is the difference between the weighing. Repeat the procedure with a further 19 capsules.
How do you test uniformity content?
The most common method for assessing content uniformity in OSDs is high-performance liquid chromatography (HPLC), observes Andrews. “HPLC has the advantages of flexibility, sensitivity, and ubiquity, and many analytical chemists are trained to use HPLC methods,” he says.
What is limit of content uniformity?
The USP acceptance criteria for content uniformity states that the relative standard deviation (RSD) of a sample of 30 units should not exceed 7.8%.
Why do we use uniformity test?
How can we improve uniformity of weight of tablets?
The filling powder is the most direct factor to influence the tablet weight. If the powder is too hard, moist, too rough or too fine, the tablet weight will also vary. The best way is to regrind the powder in order to make it with uniform size, not too rough and not too fine.