Uniformity of weight british pharmacopoeia pdf

Uniformity of weight mass of delivered doses from multidose. The term uniformity of dosage unit is defined as the degree of uniformity in the amount of the active substance among dosage units. For preparations with a content of less than 40 mg the test for 5. Pdf weight and content uniformity of lorazepam halftablets. In the case of a twocomponent tablet, uniformity of dosage units test requirement will be met by the wv. Enhancements to the bp timeline weve improved the timeline to make it easier for you to find the information you need. The united states pharmacopeia usp and the british pharmacopoeia bp. The test for uniformity of weight as stipulated in the european pharmacopoeia ph. The international pharmacopoeia ninth edition, 2019 5. Uniformity of mass of singledose preparations european pharmacopoeia 6. Uniformity of dosage the test for content uniformity is required for all dosage forms not meeting the above conditions for the 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. Uniformity of mass of singledose preparations weigh individually 20 units taken at random or, for singledose preparations presented in individual containers, the contents of 20 units, and determine the average mass.

To access the bp publication content you need to log in. Pdf weight and content uniformity of lorazepam half. Weight variation wv test can be done only on certain unit dose as shown in table 1. However, they do not have tests regarding the weight uniformity of the resultant split halves or the performance of score lines of tablets. Therefore, the requirements of this chapter apply to each active substance being comprised in dosage units containing one or more active substances, unless otherwise specified elsewere in this pharmacopoeia. The international pharmacopoeia ninth edition, 2019. Get more out of the british pharmacopoeia with the free how to use the bp guide get the how to use the bp guide. The united states pharmacopoeia usp standards for weight variation. Uniformity of weight of drug is important because this ensure the even distribution of ingredients in the drug. Therapeutic goods standard for tablets, capsules and pills tga.

The individual weights are compared with the average weight. If uncoated tablet contains 2 drug substances but only one of them meets the requirement for wv, how can the requirement be met. The aim of the present project was to prove, that a new method. A study of correlation of a low drug content product. Phenindione tablets minute 268 the monograph was amended as. To determine whether the uniformity of weight of tablets and capsules studied comply with the standard of british pharmacopoeia or not. Uniformity of weight of tablets and capsule introduction. The european pharmacopoeia test for uniformity of mass.

British pharmacopoeia 2011 british pharmacopoeia volume v. By continuing to browse this website you are agreeing to our use of cookies. Uniformity of dosage units bp 2011, usp 34 frequently asked questions. Weight and content uniformity of lorazepam halftablets. In weight variation test, measurement of contents is done by estimation of contents based on weight. Calculate the weight of drug substance equivalent to 1 average dosage unit, by a using the results. Other unit dose will need to undergo content uniformity cu test. Find out more about cookies or view our cookie policy. Weight variation and drug content of lorazepam halftablets were evaluated.