Usp 39nf 34, which was scheduled to become official may 1, 2016. The uspnf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf. Everyday low prices and free delivery on eligible orders. Analytical balances and usp interpertation of and weights and balances and weighing on an analytical balance. Usp gc for demonstrating uniformity of dosage units 9 table 1. Anda exhibit batches refer to any batch submitted in support of an anda. It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. Uniformity of dosage units test procedure all measurements of dosage units and criteria values are in percentage label claim %lc. This index is repeated in its entirety in each volume. Pdf a statistical approach to blend uniformity acceptance. Usp 36 nf 31 publication schedule uspnf english edition publication schedule publication usp 35nf 30 usp 36nf 31 usp 37nf 32 the uspnf is a uspnf online login.
Notethe 20 70 30 concentration of this solution is 0. The test for content uniformity is required for all dosage forms not meeting the above conditions for the weight variation test. Uspnf general chapter uniformity of dosage units type of posting explanatory note posting date 20apr2007 this explanatory note is intended to clarify the steps taken by usp to address issues regarding the harmonization of uniformity of dosage units. 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. Acceptance limits for the new ich usp 29 contentuniformity test. Download usp 35 nf 30 general notices free in pdf format. These products were designed to match the element concentrations and ratios stipulated in the initial version of usp while addressing safety and compatibility concerns, such as avoiding nitric acid for osmium when creating ivstock38. Oct 27, 2016 inorganic ventures originally created two stock products to meet the usp specifications. The main objective of any pharmacopeia is to provide the manufacturers of drugs and pharmaceutical dosage forms with a series of quality control tests qc that ensures high quality of the final obtained dosage forms. Definition bua is an inprocess test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients apis with other components of the drug product. The authors present their method for calculating acceptance limits consistent with usp s revised content uniformity test requirements. 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.
Compendial testing mentioned in this document refers to usp uniformity of dosage units, by content uniformity. The term uniformity of dosage unit is defined as the degree of uniformity in the amount of the drug substance among dosage units. Usp revises the new general chapter u sp is publishing a revision to the proposed general chapter topical and transdermal drug products. At each stage calculate the sample average, x, and the sample standard deviation s. Usp 35nf 30 formats usp 35nf 30 in english is available in print, online, and a new usb flash drive format. 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. The united states pharmacopeia and national formulary official dates. Alternatively, traditionally employed methods such as the direct sampling and analysis of powder blends, in conjunction with content uniformity testing of finished dosage forms may continue to be used to satisfy cgmp and compendial testing requirements. The cdrom version is also available isbn 1889788511. Quality tests in pharmacopeial forum pf, 36 6, novdec 2010. What are the limitations of content uniformity test.
Chapter 1 the glossary of terms is usually included at the end of a manuscript. Oct 04, 2011 the united states pharmacopeia and national formulary official dates. The content uniformity method may be applied in all cases. The uniformity of dosage units can be demonstrated by either of two methods, weight variation or content uniformity. Statistical considerations for establishing acceptance. The uniformity of dosage units can be demonstrated by either of two methods, content uniformity or weight variation see table 1. A statistical approach to blend uniformity acceptance criteria article pdf available in drug development and industrial pharmacy 2211. Combined index to usp 39 and nf 34 abacaacety i1 combined index to usp 39 and nf 34, volumes 14 page citations refer to the pages of volumes 1, 2, 3, and 4 of usp 39nf 34. This new general chapter was introduced in pf 35 3, mayjune 2009, and the revision is based on the comments received during the public. Performance testsuniformity of dosage units, impuritiesorganic impuritiesprocedure, additional requirementspackaging and storage, additional requirementsusp. Where different procedures are used for assay of the preparation and. Krystina ashe product manager airclean systems, inc.
N ote in this chapter, unit and dosage unit are synonymous. Blend uniformityin accordance with fda guidance for industry, andas. Uniformity of content of singledose preparations the test for uniformity of content of singledose preparations is based on the assay of the individual contents of active substances of a number of singledose units to determine. In the case of this book, it is the opinion of the author that the terms required to interpret the united states pharmacopeia usp and the national formulary nf and understand their processes is more appropriately placed upfront in. Usp packaging storage and distribution expert committee. 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 cu testing for the 21st century.
Weight and content uniformity of lorazepam halftablets. The use of stratified sampling of blend and dosage units to. Description download usp 35nf 30 general notices free in pdf format. Additional requirements usp reference standards usp docetaxel rs, additional requirements usp reference standards usp docetaxel identification rs feiwen mao drospirenone pf 366 pg. Usp acetaminophen rs of similar concentration to the sample solution in medium. Includes free cd rom using the new usp nf print with interactive presentation. Ferric chloride cs, cobaltous chlo ride cs, cupric sulfate cs, and diluent b 3.
The revision bulletin will be incorporated in the usp 40nf 35. All slides are labeled with section references in the bottom, righthand corner. Usp microbiological control of aseptic processing environments and its implications source. Revisions to the united states pharmacopeias usp uniformity test require manufacturers to establish new acceptance limits. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to l1%. Just handed our approved sop for use, verification, and maintenance of balances in qc also given usp docs weights and balances and weighing on an.
The correlation coefficient r between the weight and the content of split halves of lorazepam 2. United state pharmacopeia usp 32 national formulary nf 27. The test for content uniformity of prepacontainers rations presented in dosage units is based on the assay of and into the individual content of drug substances in a number of soft cap. The term uniformity of dosage unit is defined as the degree of uniformity in the amount of the active substance among dosage units.
Usp 35nf 30 2012 3 vol set by usp, 9781936424009, available at book depository with free delivery worldwide. Heavy metals deletion date o jan 1, 2018 publish omission of general chapter o published in usp 38nf 33 with an official date of december 1, 2015. Hot topics in visual inspection on a cold january night. The uniformity of dosage units can be demonstrated by solutions in either of two methods, content uniformity or weight unitdose variation see table 1. In the current listing of dosage forms that require testing by content uniformity see item c3 in the text, suspensions or emulsions or gels in unitdose containers or in soft capsules that are. Usp 39, nf 34 general chapter operator protection from. Understanding elemental impurities usp 232 and 233.
Content uniformity select not less than 30 units, and proceed as follows for the dosage form designated. Usp acetaminophen rs tablets acetaminophen extendedrelease tablets contain nlt 90. 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 39, nf 34 general chapter operator protection from hazardous drugs presentation by. Usp, rockville, md usa u sp is publishing a revision to the proposed general chapter topical and transdermal drug products. Analytical balances and usp interpertation of and good validation practice cgvp equipment validation. Inorganic ventures originally created two stock products to meet the usp specifications. B rie fin g 905 u nifo rm it y o f d o s a ge u nit s, usp 32 page 382 and page 1290 of pf 345 sept. The test for weight variation is applicable for dosage forms specified as w1, w2, w3, and w4. The usp nf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf. Main editionmay 1, 2012 supplements 1august 1, 2012 supplement 2december 1, 2012.
Methylene blue ts conforms to usp 35 usp3701 usp3705 neutral red ts conforms to usp 35 usp3801 usp3805 oxalic acid ts conforms to usp 35 usp3901 usp3905 perchloric acid, 0. The injections and implanted drug products parenterals product quality tests revision bulletin supersedes the version published in. Ferric chloride cs, cobaltous chloride cs, cupric sulfate cs, and diluent b 3. Compendial approvals for usp 35nf 30 monograph title monograph section scientific liaison injections pf 366 pg. United state pharmacopeia usp 32 national formulary nf 27 by us pharmacopoeial convention. Parenteral drug association pda by claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems the recently revised united states pharmacopoeia usp chapter microbiological control and monitoring of aseptic processing.
Supplements are included in the price and will be issued in february and june 2007. I am scratching my head over unless otherwise specified, when substances are to be accurately weighted for assay, the weighing is to be performed with a weighing device. Simplification of the list of dosage forms presented in table 1. Noteprepare the standard solution immediately before use. Section title slide 1 introduction and scope 9 2 list of hazardous drugs 12 3 types of exposure 15. A statistical approach to blend uniformity acceptance criteria. Blend uniformity analysis, 1999 inprocess control 2. The inspection for visible particulates may take place when inspecting for other critical defects, such as cracked or defective containers or seals, or when characterizing the appearance of a lyophilized product. Implementation of usp new chapters and on elemental impurities in pharmaceutical products introduction for more than 100 years, the standard method for measuring elemental impurities in pharmaceutical products sold in the united states has been the heavy metals test, described.
Main editionmay 1, 2012 supplements 1august 1, 2012 supplement 2december 1, 2012usp 35nf 30 formatsusp 35nf 30 in english is available in print, online, and a new usb flash drive format. Includes free cd rom using the new uspnf print with interactive presentation. The uniformity of dosage units specification is not intended to apply to suspensions, emulsions, or gels in unitdose containers intended for topical administration. Now in the sepoct 2014 usp pharmacopeial forum for public comment.
The use of stratified sampling of blend and dosage units. Usp 39 official monographs abacavir 2281 official monographs for usp 39. At each stage calculate the sample average, x, and the sample. I2 acetyalumi combined index to usp 39 and nf 34 acetyltriethyl citrate, 7141 metaproterenol sulfate inhalation, 4757 alginic acid, 7148 nacetyltyrosine, 6448 polymyxin b sulfate and bacitracin zinc alizarin complexone, 2086 nacetylltyrosine ethyl ester, 2085 topical, 5446 alkaline acid povidoneiodine topical, 5483 borate buffer, 2166.
The authors present their method for calculating acceptance limits consistent with usps revised contentuniformity test requirements. The term uniformity may refer to uniformity within a batch, or withinproduct uniformity when evaluating multidose units such as inhaled and topical products. Uniformity of content of singledose preparations european pharmacopoeia 5. This includes bioequivalence, test and commercial production batches of a drug product. Identify hazardous drug substances used in compounding based on usp define usp guidelines for compounding. Alternatively, products listed in item w4 above that do not meet the 25 mg25% threshold limit may be tested for uniformity of dosage units by weight variation instead of the content uniformity test if the concentration relative standard deviation rsd of the drug. Diluent, standard solution, sample solution, 41 0 100 and sensitivity solution. Various guidance documents regarding the establishment of content uniformity of drug product exist and are discussed in this chapter.
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