Establishing acceptance limits for uniformity of dosage. To ensure the consistency of the dosage units each unit in a batch should have an active substances content within a narrow range around the label claim. This is exceeding the limit of only maximum 2 tablets having this type of deviation. 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. The use of stratified sampling of blend and dosage units. A unit of potency of drugs, used in the united states pharmacopeia. Additional samples may be taken to further assess events such. 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. Uniformity of dosage unit usp maintaining relevance. Uniformity of dosage units using large sample sizes.
Pharmacopeia, rockville, md, usa u sp has been an important proponent of dissolution testing since the late 1960s when a usp and nf joint panel on physiological availability decided on dissolution as a test and described the apparatus that would be used. Content uniformity acceptance limit for a validation batch. For each substance to which this unit applies, the u. The use of stratified sampling of blend and dosage units to. Content uniformity acceptance testing for large sample sizes. This may indicate the ununiformed weights of the tablets and at the same time. Guidance for industry food and drug administration. It includes current chapter revision status, background information, testing.
In neither of these tests is there a requirement that individual results conform to the assay limits, typically 90% to 110% of label claim. Quality tests in pharmacopeial forum pf, 36 6, novdec 2010. Status of general chapter units and calculate the acceptance value. The content uniformity tests are used for proving the uniform distribution of the active content in a production batch. The uniformity of dosage units can be demonstrated by either of two methods, weight variation or content uniformity. The content uniformity procedure may be used in all cases. The outcome of our work was related to the recently published ph. Calculation of acceptance valuecalculate the acceptance value by the formula. Statistical basis of the new content uniformity criteria the primary concept underlying the criteria in the revised uniformity of dosage units is that of statistical tolerance intervals. 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.
It is performed by measuring the active content of n individual dosage units. It gave criteria only for the measured individual active. United states pharmacopeia and national formulary usp28nf23, supplement 1. 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. Analysis of drug content and weight uniformity for half. As part of the international conference on harmonization ich effort, the us pharmacopeia usp has revised general chapter 905, uniformity of dosage units. The uniformity of dosage units can be demonstrated by either of two methods, content uniformity or weight variation see table 1. The weight variation procedure can be used where permitted as detailed 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 united states pharmacopeia the japanese pharmacopeia. Chapter 6 will elaborate on the api release testing dissolution and disintegration from the solid oral dosage form. Defining the 5 year revision cycle chapter 5 the standard setting process. Portions of the general chapter text that are national usp text, and are not part of the harmonized text, are marked with symbols to specify this fact.
It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. 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. 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. During development, a minimum of 20 appropriately spaced dosage unit sampling points must be defined. The usp test for uniformity of dosage units specified by usp. Anda exhibit batches refer to any batch submitted in support of an anda. Pharmacopeia and a great selection of related books, art and collectibles available now at.
Acceptance critiria for uniformity of dosage units are for. Where different procedures are used for assay of the preparation and. Dosage units are defined as dosage forms containing a single dose or a part of a dose of drug substance in each unit. With different sample sizes such as n 10 and 30, their av distributions will be different, resulting in different critical av values i.
To take full advantage of the increased batch control that is gained by pat in general and large sample size in particular, there has been a demand for a test method that utilizes large sample sizes to demonstrate compliance with udu. Pdf demonstration of uniformity of dosage units using. The uniformity of dosage units specification is not intended to apply to suspensions, emulsions, or gels in unitdose containers intended for topical administration. The degree of uniformity in the amount of the active. United states pharmacopoeia abbreviation for unique selling proposition or unique selling point. Useful space principle, a principle of bridge bidding. The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to l1 and no individual content of the dosage unit is less than 1. Pdf demonstration of uniformity of dosage units using large. Particle size limits to meet usp content uniformity criteria. The usp nf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf.
Uspnf general chapter uniformity of dosage units type of posting. Compendial testing mentioned in this document refers to usp uniformity of dosage units, by content uniformity. United states pharmacopeia unit usp unit, a standard dosage unit for drugs and supplements, equal in most cases to the international unit. Usp unit synonyms, usp unit pronunciation, usp unit translation, english dictionary definition of usp unit. Usp unit definition of usp unit by the free dictionary. The weight variation procedure may be used for products for which it is permitted. Learning the language of the usp chapter 2 brief history of the united states pharmacopeianational formulary chapter 3 usp publications. Usp unit definition of usp unit by medical dictionary. This new general chapter was introduced in pf 35 3, mayjune 2009, and the revision is based on the comments received during the public. Content uniformity select not less than 30 units, and proceed as follows for the dosage form designated. Usp 35 official monographs metronidazole3909 to a suitable thinlayer chromatographic plate see chromatogpackaging and storagepreserve in wellclosed, lightresis raphy. The uniformity of dosage units specification is not intended to apply to suspensions, emulsions, or gels in unitdose containers intended for topical external, cutaneous administration.
Dosage units are defined as dosage forms containing a single dose or a part of. Sep 27, 2006 a unit used in the united states to measure the potency of a vitamin or drug, that is, its expected biological effects. The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to l1% and all individual dosage units fall within the ranges calculated using l2 factor. The revision became official on january 1, 2007 through the sixth interim revision announcement to usp 29nf 24 in pharmacopeial forum 1. You have to look up what that is for each drug, and convert it. Oct 04, 2011 the usp 35 nf 30 features more than 4500 monographs with offcial standards of identity, strength, quality, purity, packaging, and labeling for substances and dosage forms.
The european pharmacopoeia had loose criteria for content uniformity till july 1, 2005. November 29, 2006 demystifying the standardssetting. Situation compendial expectation 30 units for any product general notices 3. N ote in this chapter, unit and dosage unit are synonymous. The uniformity of dosage units can be demonstrated by either of the two methods.
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. From the results, we can see that the 7 tablets weighed 664. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloro usp reference. 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. Usp unit plural usp units a unit of potency of drugs, used in the united states pharmacopeia. The acceptance value of the first 10 dosage units is less than or equal to l1%. 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. All whole tablets met the usp acceptance criteria for the uniformity of dosage units. Drug development and industrial pharmacy, 01 jun 2009, 356. The requirements of this chapter apply both to dosage units containing a single active ingredient and to dosage units containing two or more active ingredients. Pharmacopeia usp manual states that each unit within a single lot of a given medication should have drug substance content that is within a narrow range around the labeled claim. The uniformity of dosage units general chapter was incorporated into and became official with the second supplement to usp 34nf 29. Particle size limits to meet usp content uniformity. The uniformity of dosage units can be demonstrated by solutions in either of two methods, content uniformity or weight unit dose variation see table 1.
Uniformity of dosage unit usp maintaining relevance jon clark, vp industry standards and collaboration. United states pharmacopeia and national formulary usp28nf23. An alternative estimation of the particle distribution width d 90 d 50 assumes a lognormal distribution and is calculated by. It is to do with the activity or potency of a drug. The uspnf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf. This includes bioequivalence, test and commercial production batches of a drug product. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in the table and none deviates by more than twice that percentage. In addition, a proposal of a new general chapter for the european pharmacopoeia has been introduced. 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. Status of general chapter uniformity of dosage units type of posting. You have to look up what that is for each drug, and convert it into whatever units you need. Determination and acceptance limits of uniformity of. 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. 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.
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. A compendial test used routinely in pharmaceutical manufacturing, the us pharmacopeia usp uniformity of dosage unit udu test is familiar across the. The content uniformity method may be applied in all cases. Should you have any questions, please contact desmond hunt, ph. In uniformity of dosage units udu test, the single limit for acceptance value av of not more than nmt 15 cannot discriminate between the conforming and nonconforming lots of products. Acceptance limits for the new ich usp 29 contentuniformity test. Establishing acceptance limits for uniformity of dosage units. Making sure you have uptodate information chapter 4 the usp convention process. Contents uniformity weight or volume of packaged dosage forms. Usp revises the new general chapter u sp is publishing a revision to the proposed general chapter topical and transdermal drug products. The test for content uniformity 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.
Determination and acceptance limits of uniformity of content. The revision bulletin will be incorporated in the usp 40nf 35. What are the limits for uniformity dosage content for. Content uniformity and assay requirements in current. United states pharmacopeia and national formulary usp28nf23, supplement 1 usp on. Food and drug administration has determined the biological effect associated with a dose of 1 usp unit. 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. Ppt uniformity of dosage units powerpoint presentation. Usp 39nf 34, which was scheduled to become official may 1, 2016. Table 51 provides a summary of tests discussed in chapter 5.
328 1079 526 182 537 1490 775 1361 157 318 969 328 389 471 141 1111 610 1377 1260 963 1022 737 1022 537 1040 38 908 1460 789 60 386 945 475 43 1119 668 118 1455 425 169