A monograph for heparin entered the usp in 1950, with tests for identity, strength, quality, purity and potency. Anita szajek, phd, and tina morris of usp highlight usps revisions to the heparin sodium monograph in the september 2012 issue of pharmtech. United states pharmacopeia and national formulary usp 37 nf 32. Heparin occurs in and is obtained from liver, lung, mast cells, etc.
Bd vacutainer heparin tube with hemogard closure green. In response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin. Heparin, also known as unfractionated heparin ufh, is a medication and naturally occurring glycosaminoglycan. A single usb flash drive, contains a copy of the formerly official usp37nf32 edition, with supplements. Due to the prevalence of contaminated heparin products, usp has. Sep, 2012 in response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin. Note the usp heparin unit is defined by the usp heparin sodium reference standard and can be independent of international units.
Usp optimizes identification tests and impurities procedures. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for. By downloading the chapter, you agree to usp s privacy policy. 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. Aug 11, 2019 heparin sodium injection is an anticoagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism. Heparininduced aldosterone suppression and hyperkalemia. In this application note typical results obtained with the alexys analyzer are reported, demonstrating its performance. Question and answers about changes to the usp heparin monograph. Usp updates heparin sodium monograph pharmaceutical technology. Question and answers about changes to the usp heparin. One is an injectable solution, which you inject under your skin.
Reports for heparin sodium injection usp single use vial. The proposed revision aligns the usp heparin sodium injection monograph with by removing the conflicting labeling requirement in the monograph. Usp reference standards are specified for use in conducting official uspnf tests and assays. Heparin injectable solution only comes as a generic drug. To download the complimentary usp general chapter pharmaceutical compounding sterile preparations, please click here. Usp further strengthens quality standards for heparin. It is anticipated that the revision will be published as a proposed interim revision announcement for public comment in pf 383 on may 1, 2012, with an official date to be determined. Heparin is a glycosaminoglycan obtained from animal tissues that is widely used as a clinical anticoagulant.
Simply select your manager software from the list below and click on download. Heparin sodium usp method 2 summary the heparin analysis was evaluated on an antec alexys lcec analyzer according the official 2014 heparin sodium usp monograph 37 nf32 5. Prescribing information heparin sodium injection usp 1 000 and10 000 usp unitsml sterile anticoagulant description heparin sodium injection uspis a sterile, pyrogenfree solution of a highly purified sodium salt of heparin, a high molecular weight. Food and drug administration fda have shown that heparin sodium, usp heparin made under the new united states pharmacopeia usp monograph. Heparin sodium injection, usp is available in the following concentrationsml. Heparin is a sulfurrich glycosaminoglycan with anticoagulant property.
Download uspnf general chapter prescription container. The complex binds to and irreversibly inactivates thrombin and other activated clotting factors, such as factors ix, x, xi, and xii, thereby preventing the polymerization of fibrinogen to fibrin and the subsequent formation of clots. List of united states pharmacopoeia usp analytical reference standards of heparin and related impurities. The us regulatory and pharmacopeia response to the global. Usp encourages input from all interested parties regarding 11 and its companion chapters. Heparin lock flush solution, usp, is a solution containing heparin sodium, a heterogenous. Please complete the following form to download uspnf general chapter for free. Heparin is a vital pharmaceutical anticoagulant drug and remains one of. Effective may 1, 20, a new usp labeling standard for heparin sodium injection, usp and heparin lock flush solutions, usp was implemented. Heparin sodium heparin sodium injection, usp for subcutaneous or intravenous use ordering information 2,000 usp units2 ml 1,000 usp unitsml sdv ndc 00069004301 unit of sale 25 singledose vials dosage form solution unit of sale dimensions l x w x h 3. Laboratory studies performed at the request of the u. Gpc, in accordance with the usp 37 heparin monograph method, 11 with nonessential minor modifications. The revisions to the usp heparin monograph, which became official on october 1, were made in response to incidents in 20072008 where heparin was intentionally adulterated with oversulfated chondroitin sulfate oscs during the manufacturing process. It is intended to be used for the collection, and preservation andor transport, of blood for analysis andor other investigation e.
It is to be administered by intravenous or deep subcutaneous routes. For cms providers and interested health care advocates. Heparin binds to antithrombin iii to form a heparinantithrombin iii complex. Please call usp customer service at 18002278772 or 3018810666 to order. Chromatographic determination of molecular weight distributions for heparin sodium. Specifically it is also used in the treatment of heart attacks and unstable angina. Tools for the quality control of pharmaceutical heparin mdpi. Do not use heparin injection to flush clean out an intravenous iv catheter. On the basis of comments received on the published and new methods submitted by the industry, it is proposed to.
Usp updates heparin sodium monograph pharmaceutical. Usp provides safety data sheets sds for all reference standards and usp certificates for some reference standards. The 1 h nuclear magnetic resonance nmr acceptance criteria in the new heparin us pharmacopeia usp monograph do not take into account potential structural modifications responsible for any extra signals observed in 1 h nmr spectra, some purified heparins may be noncompliant under the proposed new usp guidelines and incorrectly classified as unsuitable for pharmaceutical use. Uh is different from low molecular weight heparin lmwh in the. Heparin sodium and heparin calcium monographs uspnf. Heparin sodium cas 9041081 in stock ardeparin sodium 9041081. Prescribing information heparin sodium injection usp 1 000 and10 000 usp unitsml sterile anticoagulant description heparin sodium injection uspis a sterile, pyrogenfree solution of a highly purified sodium salt of heparin, a high molecular weight polysaccharide derived from porcine intestinal mucosa. Assay of heparin the anticoagulant activity of heparin is determined in vitro by comparing its ability in given conditions to delay the clotting of recalci. If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Download the heparin sodium monograph download the heparin. A sterile glass or plastic tube, sealed with a stopper, containing a premeasured amount of vacuum and the anticoagulant lithium heparin. New usp standards for heparin products will result in decreased potency. It is also used before surgery to reduce the risk of blood clots.
Heparin sodium monograph comment period extended uspnf. Any revisions to the monograph will be considered for inclusion in the usp 37 nf 32. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. The unit for antifactor x a activity is defined by the usp heparin sodium reference standard and is equivalent in potency to that standard. The respective units are not equivalent see general notices. It is given by injection into a vein or under the skin. Analysis of heparins derived from bovine tissues and comparison. The molecular weight ranges from six to twenty thousand. List of usp reference standards related to heparin. Heparin sodium sodium chloride 5,000 usp units 7 mg ph 5.
Aug 03, 2017 laboratory studies performed at the request of the u. Heparin sodium injection is an anticoagulant indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism. Clinical pharmacology heparin inhibits reactions that lead to the clotting of blood and the formation of. Its function is unknown, but it is used to prevent blood clotting in vivo.
A highly acidic mucopolysaccharide formed of equal parts of sulfated dglucosamine and dglucuronic acid with sulfaminic bridges. New usp standards for heparin includes new identity and. Heparin binds to antithrombin iii to form a heparin antithrombin iii complex. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from bovine lung tissue, standardized for anticoagulant activity.
Us pharmacopeia announces revised heparin monographs and. Therefore, general chapter 37 biological assay validation emphasizes validation approaches that provide 38 flexibility to adopt new bioassay methods, new biological drug products, or both in 39 conjunction for the assessment of drug. Dglcns6s 1, where idoa is iduronic acid, glcn is glucosamine, and s is sulfo. Heparin sodium for assays united states pharmacopeia usp. As a medication it is used as an anticoagulant blood thinner. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity.
Heparin sodium heparin sodium injection, usp for subcutaneous or intravenous use ordering information 30,000 usp units30 ml 1,000 usp unitsml mdv ndc 000690703 unit of sale 10 multidose vials dosage form solution unit of sale dimensions l x w x h 3 x 6. Structural formula of heparin sodium representative subunits. Working with fda, manufacturers, and other stakeholders, the us pharmacopeial convention usp responded to this public health crisis by embarking on a revision of its public quality standards for heparin to enable the identification of oscs and related contaminants. Pdf usp compendial methods for analysis of heparin. Adverse health events associated with the use of adulterated or counterfeit heparin prompted the centers for disease control and prevention cdc and fda to begin a nationwide investigation in january 2008 of the commonly used bloodthinning drug. Each ml contains 1,000, 2,500, 5,000, 7,500, 10,000, 15,000, or 20,000 usp units heparin sodium derived from porcine intestinal mucosa standardized for use as an anticoagulant, in water for injection, and not more than 10 mg benzyl alcohol as a preservative. Jun 24, 2014 united states pharmacopeial convention 2014 usp 37 official monographs. Pages are watermarked to positively identify content as formerly official. Tubex heparin sodium injection, usp is a sterile solution. Heparin is an anticoagulant blood thinner that prevents the formation of blood clots heparin is used to treat and prevent blood clots caused by certain medical conditions or medical procedures.
Analysis of heparins derived from bovine tissues and. Mulloy b 2012 structure and physicochemical characterisation of heparin. Heparin sodium for assays united states pharmacopeia usp reference standard. New usp standards for heparin products will result in. Bec366664 lithium heparin 37 usp units bec367884 lithium heparin 75 usp units bec367886 lithium heparin 95 usp units bec367671 sodium heparin 33 usp units bec367871 sodium heparin 75 usp units bec367878 sodium heparin 90 usp units bd. Usp also provides reference standards specified in the food chemicals codex as well as authentic substanceshighquality chemical samplesas a service to analytical, clinical, pharmaceutical and research laboratories. Heparin sodium injection heparin sodium injection dailymed. A sterile glass or plastic tube, sealed with a stopper, containing a premeasured amount of vacuum and the anticoagulant sodium heparin. Usp heparin sodium molecular weight calibrant reference standard by.
United states pharmacopeial convention 2014 usp 37 official. Pharmacopeial usp convention announces that revised monographs for heparin sodium and heparin calcium in the united states pharmacopeia usp are now available and official on the usp. By downloading the chapter, you agree to usps privacy policy. Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease. Food and drug administration fda has alerted healthcare professionals to changes in the united states pharmacopeia usp monograph for heparin products, effective october 1, 2009. Because of the suspected serious adverse events associated with the contamination of heparin with oversulfated chondroitin sulfate, usp has further revised the usp heparin sodium monograph. New heparin standards recently adopted by the united states pharmacopeia usp include new tests to ensure the quality of the drug.
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