Pharmacists often use and misuse this wv test by doing this test on all dosage units. Statistical considerations for establishing acceptance. Usp, rockville, md usa u sp is publishing a revision to the proposed general chapter topical and transdermal drug products. Usp gc for demonstrating uniformity of dosage units 9 table 1. United states pharmacopeial convention, incorporated, 2011. However, limits are set not from the average content of the sample, but from the specified amount of active ingredient by. The preparation complies with the test if not more than one of the individual contents of the total sample of 30 dosage units is outside 85 to 115 percent of the average content and none is outside the limits of 75 to 125 percent of the average content. Quality tests in pharmacopeial forum pf, 36 6, novdec 2010. Uniformity of dosage unitscomparative study of methods. Dissolution and uniformity of dosage units, require multiple dosage units in conjunction with a decision scheme. Content uniformity cu of pharmaceutical dosage units can be affected by active pharmaceutical ingredient api particle size and size distribution.
Usp 41 nf 36 the united states pharmacopeial convention. Ankur choudhary print question forum no comments weigh individually 20 units selected at random or, for single dose preparations in individual containers, the contents of 20 units, and calculate the average weight. Dosage units are defined as dosage forms containing a single dose or a part of. Acceptance limits for the new ich usp 29 contentuniformity test. Previous stage 6 posting in pf 35 3, 2009 previous stage 6 posting in pf 32. For different sample sizes, such as n 10 and 30, their av distributions will be different in pattern, thus resulting in different critical av values i. Maximum volume median particle diameter d 50 in m predicted to pass usp stage i content uniformity criteria with 99% confidence as a function of dose mg and geometric standard deviation. Usps revision of the standard for uniformity of dosage units has been approved. Evaluation of pharmaceutical quality of conventional.
Metered dose inhaler mdi and dry powder inhaler dpi products quality considerations. Where different procedures are used for assay of the preparation and. For example, the content uniformity of the dosage unit can be significantly impacted by psd of the api, which is especially of concern for low dosage drugs 5. The united states pharmacopeia usp and the british pharmacopoeia bp contain a quality control test regarding the weight uniformity of dosage units.
November 29, 2006 demystifying the standardssetting. Pdf demonstration of uniformity of dosage units using large. Particle size limits to meet usp content uniformity criteria. Uniformity of dosage units 1 is one of the most commonly employed compendial tests to evaluate the dosage units. To assure the consistency of dosage units, the drug content of each unit in a batch should be in a narrow range near the claimed label strength. For products marketed in the united states, the fda provides information on bioequivalence in the orange book. A unit of potency of drugs, used in the united states pharmacopeia. Many modifications of compendial cu test have been introduced and several alternatives have been suggested. Uspnf general chapter uniformity of dosage units type of posting. See general notices and requirements, tests and assays, test results. Pharmaceutical dosage forms765 maceutical preparations, which are given elsewhere in thistent uniformity does not rely on the assumption of blend pharmacopeia.
Metered dose inhaler mdi and dry powder inhaler dpi drug. A tests for dissolution and uniformity of dosage units evaluate different properties of dosage forms. To assess the uniformity of dosage units in a filmcoated fdc tablet, containing more than 25 mg of each active ingredients but representing less than 25% of the whole tablet weight apart from pza, the usp recommends to estimate the statistical parameter acceptance value av by the content uniformity cu method. Usp revises the new general chapter u sp is publishing a revision to the proposed general chapter topical and transdermal drug products. Uniformity of dosage units are determined from two ways. Other readers will always be interested in your opinion of the books youve read. Determination and acceptance limits of uniformity of. Pdf demonstration of uniformity of dosage units using.
This new general chapter was introduced in pf 35 3, mayjune 2009, and the revision is based on the comments received during the public. Guidance for industry food and drug administration. At each stage calculate the sample average, x, and the sample standard deviation s. Where different procedures are used for assay of the preparation and for the content uniformity test, it may be. Uniformity of dosage units how is uniformity of dosage. Isoniazid, pyrazinamide and rifampicin content variation. Uniformity dosage unit usp dose biochemistry tablet pharmacy. For any questions about the pdg and its processes, please see the pharmacopeial. To perform the contentuniformity test, test 10 dosage units. Chapter 6 will elaborate on the api release testing dissolution and disintegration from the solid oral dosage form.
A usp monographs provide publicly accessible standards for drug products. Uniformity of dosage units test procedure all measurements of dosage units and criteria values are in percentage label claim %lc. At each stage calculate the sample average, x, and the sample. Uniformity of dosage unit usp maintaining relevance jon clark, vp industry standards and collaboration.
What are the limits for uniformity dosage content for tablets. Table 51 provides a summary of tests discussed in chapter 5. Previous authors have estimated this impact but use of different particle size descriptors led to confusion and difficulty in. The united states pharmacopeia and national formulary official dates. Determination and acceptance limits of uniformity of content. This can be demonstrated by two methods, namely, content uniformity and weight variation tests.
Ppt uniformity of dosage units powerpoint presentation. Content uniformity select not less than 30 units, and proceed as follows for the dosage form designated. Usp unit definition of usp unit by medical dictionary. Main editionmay 1, 2012 supplements 1august 1, 2012 supplement 2december 1, 2012usp 35 nf 30 formatsusp 35 nf 30 in english is available in print, online, and a new usb flash drive format.
An alternative estimation of the particle distribution width d 90 d 50 assumes a lognormal distribution and is calculated by. Content uniformity tests are used to establish that the dosage units of a drug product consistently contain the specified amount of drug active pharmaceutical ingredient. The uniformity of dosage units for the revised test can be demonstrated by either content uniformity or weight variation. This test is given in general chapter uniformity of dosage units of the usp, in 2. Chapter 2 brief history of the united states pharmacopeianational. Let s i be the criteria of passing stage i, i 1, 2. Situation compendial expectation 30 units for any product general notices 3. Uniformity of weight of singledose preparations ankur choudhary print question forum no comments weigh individually 20 units selected at random or, for single dose preparations in individual containers, the contents of 20 units, and calculate the average weight. Astm standard e2810 provides a methodology for establishing confidence in passing the usp uniformity of dosage units udu test, and provides acceptance limits for sample means and standard. Weight and content uniformity of lorazepam halftablets. Transfer an accurately weighed portion of the powder, equivalent to about 250 mg of sucralfate, to a 250ml screwcapped bottle, and proceed as directed in the test for acidneutralizing capacity under sucralfate, beginning with add 100.
Dec 21, 20 weight variation wv test can be done only on certain unit dose as shown in table 1. Section vii number of samples and the acceptance criteria were based on limits published in usp general chapter uniformity of dosage units this was intentional to avoid any changes to the existing quality standard or an increase number of dosage units to be tested. The uniformity of dosage units general chapter was incorporated into and became official with the second supplement to usp 34nf 29. Avthe only quality attribute in uniformity of dosage units udu. Uniformity of dosage units how is uniformity of dosage units abbreviated. Calculation of acceptance valuecalculate the acceptance value by the formula. Assay 10 units value under content uniformity or under mass dividually using an appropriate analytical method. Usp 23uniformity of dosage units, content uniformity method. These tests, albeit using a number of dosage units,are in fact the singlet determinations of those particular attributes of the specimen. Dosage units are defined as dosage forms containing a single dose or a part of a dose of an active substance in each dosage unit.
Content uniformity test suitable for large sample sizes, drug information journal 40 3, 337344 2006. Uniformity of dosage units bp 2011, usp 34 usp 28nf 23 harmonized general chapter on page 25052510 with an implementation date april 1, 2006 approved by the pharmacopeial discussion group pdg usp postponed the implementation date to january 1, 2007. Metered dose inhaler mdi and dry powder inhaler dpi. Particle size limits to meet usp content uniformity. Determining the probability of passing usp content uniformity. The article reports on the cudalexcel program, a set of ms excel programs transformed and extended from bergums cudal version 2 sas program, designed for industry practitioners to calculate the usp passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios, and for both immediate release and extended release requirements. Determined number of units as % and for n30 outside differents ranges of label claim, where the characteristics of a normal distribution curve were applied, for samples with differents values of active ingredient, and with the maximum relative standard deviation allowed by the test of uniformity of dosage units of usp 23. Content uniformity acceptance testing for large sample sizes. Usp 38 the united states pharmacopeia 1nf 33 the national formulary volume 4a by authority of the united states pharmacopeial convention prepared by the council of experts and its expert committees official from may 1, 2015 the designation on the cover of this publication, usp nf 2015, is for ease of identification only.
Weight variation wv test can be done only on certain unit dose as shown in table 1. Inprocess dosage units must be sampled over the entire batch to assure the entire blender is uniform, including beginning and end of run weight correction is not allowed when using dosage unit content uniformity data for batch release if the inprocess dosage unit is not the final dosage form e. Other unit dose will need to undergo content uniformity cu test. The derivations that follow are based on the individual dosage values obtained by either of the two methods. Uniformity of dosage unitscomparative study of methods and. Sep 02, 2016 inprocess dosage units must be sampled over the entire batch to assure the entire blender is uniform, including beginning and end of run weight correction is not allowed when using dosage unit content uniformity data for batch release if the inprocess dosage unit is not the final dosage form e. This general chapter is harmonized with the corresponding texts of the european pharmacopoeia and. The test for delivereddose uniformity is required for inhalers e. May 2009 questions and answers dissolution technologies.
The united states pharmacopeia the japanese pharmacopeia. The test for content uniformit y is based on the assay of the individual content of drug substances in a number of individual dosage units to determine whether the individual content is within the limits set. The term uniformity may refer to uniformity within a batch, or withinproduct uniformity when evaluating multidose units such as inhaled and topical products. A language and environment for statistical computing. In addition, a proposal of a new general chapter for the european pharmacopoeia has been introduced. The uniformity of dosage units can be demonstrated by either of two methods, content uniformity or weight variation see table 1. Establishing acceptance limits for uniformity of dosage. United states pharmacopeia and national formulary, volumes. Successful development and manufacture of dosage forms requires careful. Performance testsuniformity of dosage units, impuritiesorganic impuritiesprocedure, additional requirementspackaging and storage, additional requirementsusp reference standards usp alprazolam rs ravi ravichandran ammonio methacrylate copolymer pf 366 pg. Margareth marques usp scientific liaison,a howard rytting,b steve shaw, kailas thakker, and avi. Uniformity of weight of tablets and capsule tf lab 1. Acidneutralizing capacity weigh and finely powder not fewer than 20 tablets. The content uniformity method may be applied in all cases.
To perform the content uniformity test, test 10 dosage units. Sep 02, 2016 section vii number of samples and the acceptance criteria were based on limits published in usp general chapter uniformity of dosage units this was intentional to avoid any changes to the existing quality standard or an increase number of dosage units to be tested. Performance tests uniformity of dosage units, impuritiesorganic impuritiesprocedure, additional requirementspackaging and storage, additional requirements usp reference standards usp alprazolam rs ravi ravichandran ammonio methacrylate copolymer pf 366 pg. What are the limits for uniformity dosage content for. Determining the probability of passing usp content. Establishing acceptance limits for uniformity of dosage units. Transfer about 35 mg of acebutolol hydrochloride, accurately weighed, to a 250. Content uniformity cu testing was developed and improved to control the effectiveness and safety of dosage units. Content uniformity acceptance testing for large sample sizes 1 kim vukovinsky, pfizer james bergum, bristolmyers squibb may 25, 2011. Contents uniformity weight or volume of packaged dosage forms.
In weight variation test, measurement of contents is done by estimation of contents based on weight. In the test, the acceptance value av is the key statisticsbased acceptance parameter with the limit of not more than 15 to measure the uniformity degree of the dosage units in terms of content uniformity or weight variation as. Uniformity of dosage units official december 1, 2011 in conditions of normal use, and express the results as dein which the terms are as defined in table 2. Uniformity of dosage units to ensure the consistency of dosage units, each unit in a batch should have an active substance content within a narrow range around the label claim. General 52 53 mdis and dpis are products that deliver one or more drug substances to the site of action 54 through the inhalation route. Uniformity of dosage unit usp maintaining relevance. Uniformity of weight of singledose preparations learn how to determine the uniformity of weight of pharmaceutical preparations. Uniformity of dosage units this test is applicable for. United states pharmacopeia and national formulary, volumes volume 3 of the united states pharmacopeia, the united states pharmacopeia. Uniformity of weight of tablets and capsule introduction.
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