United states pharmacopeia 39, national formulary 34 usp, general chapter 800, section 2. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use chapter appears in usp 38 nf 33 official may 1 2015 chapter 231 is a visual comparison test that compares the metallic impurities in a solution, which are colored by a sulfide ion, with a control solution prepared. General chapter pharmaceutical compounding sterile. Other industry organizations have provided guidance for the validation of alternate microbiological methods. Usp 41 nf 36 becomes official may 1, 2018 the usp nf is a combination of two compendia, the united states pharmacopeia usp and the national formulary nf.
Usp 735 as an alternative to usp 233 for elemental. Elemental impuritiesprocedures chemical tests second supplement to usp 35 nf 30 add the following. All rights of this 2015 usp 38 the united states pharmacopeia file. Eur 8 jp 16 2nd supplement forth edition 4th supplement 2. Page citations refer to the pages of volumes 1, 2, 3, and 4 of usp 38nf 33 and its first and second. Extractables are organic and inorganic chemical entities that are released from a pharmaceutical packagingdelivery system, packaging component, or packaging material of construction and into an extraction solvent under laboratory conditions. In addition to official articles, this index may also include items recently omitted from the usp nf in the indicated book or supplement. Usp 39 published general chapter residual host cell protein measurement in biopharmaceuticals the official version can be found in the usp nf. Sterile drug products may be contaminated via their pharmaceutical ingredients, process water, packaging. Combined index to usp 38 and nf 33 the following index is for. Pb and as for an analysis of an oral solid drug product with a daily dose of 10gday using an inductively coupled plasmamass spectrometry icpms.
Applicability of standards early adoption of revised standards in advance of the official date is allowed by usp. In accordance with usp s rules and procedures of the 20102015 council of experts rules and except as provided in section 7. According to section 501 of the federal food, drug, and cosmetic act, assays and specifications in monographs of the united states pharmacopeia and the national formulary constitute legal standards. 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. Opinion on solubility of synthetic amorphous silica sas. Download link from urldecrypt, direct link under maintenance. Usp 38 nf 33 united states pharmacopoeia and national formulary 2015. This index is repeated in its entirety in each volume. Some dosage forms of drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of. The usp nf contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. It specifically addresses therapeutic protein injections and related preparations, allowing use of smaller test product volumes and smaller test aliquots to determine particulate matter content, with samplehandling instructions that take into account the issues associated with the analysis. Accelerated revisions are published monthly on the usp website. The following index is for convenience and informational use only and shall not be used for interpretive purposes. Additional requirements usp reference standards edith chang.
The united states pharmacopeia national formulary usp nf is a combination of two official compendia, the united states pharmacopeia usp and the. Nf 33 official monographs acacia 6503 official monographs for nf 33 acacia definition acacia is the dried gummy exudate from the stems and branches of acacia senegal l. A sound cleaning and sanitization program is needed for controlled environments used in the manufacture of pharmacopeial articles to prevent the microbial contamination of these articles. Legal recognition united states pharmacopeia, thirtyeighth revision, and the the usp and nf are recognized in the laws and regulanational formulary, thirtythird edition, supersede all earliertions of many countries throughout the world. Singledose containers select 1 container if the volume of the container is 10 ml or more, 3 containers if the nominal volume is more than 3 ml and less than 10 ml, or 5 containers if the nominal volume is 3 ml or less. A single usb flash drive, contains a copy of the formerly official usp37nf32 edition, with supplements. Usp standards are used in more than 140 countries around the world. Usp 38 nf 33 united states pharmacopoeia and national. Description transparent, colorless, mobile, volatile liquid.
New low molecular weight heparin molecular weight determinations pf 401 pg. 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. Example usp collation of feedback usp 38 nf 33 apply to be an observer at usp meetings. Legal recognition united states pharmacopeia, thirtyeighth revision, and the the usp and nf are recognized in the laws and regula national formulary, thirtythird edition, supersede all earliertions of many countries throughout the world. United states pharmacopeia 38 na tional formulary 33. Iras are published everyothermonth and include a comment period revision bulletins are published every month and do not. Analysis of biological assays general information first supplement to usp 35 nf 30 add the following.
Usp revision and implementation plan for the elemental. Depending on the specific purpose of the extraction study discussed below, these laboratory conditions e. For more information on how to access the usp nf click here. The united states pharmacopeia and national formulary are updated annually, plus two supplements are published each year. The usp nf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf. Page citations refer to the pages of volumes 1, 2, 3, and 4 of usp 38nf 33. The united states pharmacopeia world health organization. Heavy metals deletion date o jan 1, 2018 publish omission of general chapter o published in usp 38 nf 33 with an official date of december 1, 2015.
Solubility miscible with water, with alcohol, with ether and with chloroform. It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. The 2015 usp convention meeting was held april 22 25 of this year at the jw. The mapp states, however, that these compendia are not intended to be in place of or addition to the official uspnf. The article will provide the key findings of the usp excipients workshop. Take up individually the total contents of each container selected into a dry syringe of a capacity not exceeding three times the volume to be measured and fitted with a 21. Combined index to usp 38 and nf 33 abacaaceto i1 combined index to usp 38 and nf 33, including second supplement page citations refer to the pages of volumes 1, 2, 3, and 4 of usp 38 nf 33 and its first and second supplement. Final opinion on solubility of synthetic amorphous silica sas. Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packagingdelivery system, packaging component, or packaging material of construction and into an extraction solvent under laboratory conditions.
The table below gives the details of the iras that will apply to usp 38nf 33. United states pharmacopeia 38 national formulary 33. Free download of united states pharmacopoeia30 usp 30. Index to usp 38nf 33, second supplement the following index is.
United states pharmacopeia and the national formulary usp. The characteristics defined in this chapter may be used to establish this comparison. The suitability of a new or modified method should be demonstrated in a comparison study between the usp compendial method and the alternate method. The united states pharmacopeia and national formulary usp nf, recognized by federal law as an official u.
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