What is the weight variation test?
What is the weight variation test?
Uniformity of Weight/ Weight variation test The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights. The individual weights are compared with the average weight.
What is the number of tablets required in weight variation test?
(i.e. the whole test will consume 18 tablets). Not less then 16 tablets disintegrate completely within the time if more then two tablets (from the 18) fail to disintegrate, the batch must be rejected.
What are the evaluation test for tablets?
Tablet hardness: The tablets must be hard enough to withstand mechanical stress during packaging, shipment, and handling by the consumer. Section <1216> of the USP 24/NF19 outlines a standard tablet friability test applicable to manufactured tablets.
Which method is used to measure the tablet strength?
Methods for measuring the mechanical strength of a tablet include crushing, fracturing, and bending tests (2). Figure 3: Graph of tablet-crush test. The crush test is usually performed on a round tablet standing on its rim, or, for a capsule-like tablet, parallel to the longest axis.
What are the possible causes for weight variation for tablets?
The actual cause for this problem is the lack of weighing systems that are sufficiently fast to weigh or dose the required weight for each single tablet. Since this is not possible, each tablet press doses a certain amount of powder into the die and this powder is then pressed into tablets by the upper and lower punch.
Why do we perform weight variation test?
The objective of the weight variation test is to ensure – good manufacturing practices (GMP), appropriate size of the tablets and the content uniformity of the formulation (Yoshida, 1999). The United States Pharmacopoeia (USP) provides criteria for tablet weight variation of intact dosage units.
What are the possible causes for weight variation for tablets or capsules?
What is the limit for friability of tablets?
A maximum loss of weight (from a single test or from the mean of the three tests) not greater than 1.0 percent is acceptable for most tablets.
Why do tablets use weight variation?
How do tablets prevent variation weight?
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.
What are the possible causes for weight variation for capsules?
However the two most common causes of weight variation are the differences in the bulk densities and particle size distribution during compression. From the results, all our capsules are having a deviation of ± 10%, which means that all capsules have uniform weights.
What is weight variation test in pharmacy?
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).
Why did the tablets fail the test of weight uniformity?
The tablets tested have failed the test of weight uniformity while the capsules tested have passed the test of weight uniformity. The non-uniformity of the tablets may be caused by the systematic error of the weighing balance itself.
How is the weight of the tablet determined?
An integrated load cell automatically determines tablet weight with maximum accuracy and attributes it to individual samples. The slider technology perfectly aligns evenly shaped oblongs for easy determination of width, length and tablet hardness.
What are the quality control tests in tablet formulation and manufacturing?
In tablet formulation development and during manufacturing of tablet dosage forms, a number of quality control tests are performed to ensure that tablets produced meet the requirements as specified in official compendium and conventional requirements established by the industries over the years.
