The electropherogram of the test solution is test solutionreconstitute an accuratelysimilar to that of the standard solution, and does. Protamine is used therapeutically to reverse the activity of heparins. Heparin sodium is the sodium salt of sulfatedpackaging and storagepreserve in tight con. We have been supplying the global pharmaceutical industry for over ten years and are trusted supply partners to many of the worlds leading pharmaceutical companies. Nutescu, pharmd, clinical professor of pharmacy practice at the university of illinois college of pharmacy, stated that. Usp believes that both methods are needed to quickly allow for a qualified supply of heparin and to address the current adulteration of the heparin supply. Usually, 7,500 usp units of heparin sodium are added to 100 ml of 0. 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. Usp encourages any manufacturers that have methods for consideration in stage 2 to submit them to dr. Chromatographic determination of molecular weight distributions for heparin sodium. This sixmonth implementation timing gives users more time to bring their methods and procedures into compliance. Specifically it is also used in the treatment of heart attacks and unstable angina. Heparin coated blood oxygenators are available for use in heartlung machines.
Usp updates heparin sodium monograph pharmaceutical. Nlt 20 mgml of usp heparin sodium identification rs in deuterium oxide with 0. Us pharmacopeia announces revised heparin monographs and. This change from the existing usp requirements is intended to prevent medication errors. On the basis of comments received on the published and new methods submitted by the industry, it is proposed to. Heparin sodium usp monograph specify that gal may not exceed 1. Purchase heparin sodium for assays reference standard, 9.
Nlt 20 mgml of usp heparin sodium tion and sample solution in duplicate. Analysis of heparin and lmw heparin, including enoxaparin sodium. 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. Jun 24, 2014 usp compendial methods for analysis of heparin. Formation of this complex can result in disruption of the heparinantithrombin iii complex responsible for the anticoagulant activity of heparin. Activity approximately 100 unitsmg 25 ku 100 ku 500 ku ku 101932 heparin, sodium salt solution.
Heparin is a heterogenous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. Protamine, a strongly basic compound, forms complexes with heparin sodium or heparin calcium, which are acidic compounds. Heparin sodium injection, usp porcine, preserved with benzyl alcohol, is available as follows. Heparin can interfere with some immunoassays, however.
Prepare 1% ww usp over water bath set at 37, transfer 120 l of ph 8. 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. Assay of heparin the anticoagulant activity of heparin is determined in vitro by comparing its ability in given. In this application note typical results obtained with the alexys analyzer are reported, demonstrating its performance for the analysis of organic impurities in. Heparin sodium for assays united states pharmacopeia usp reference standard. In this application note typical results obtained with the alexys analyzer are reported, demonstrating its performance for the analysis of organic impurities in heparin products. Aug 03, 2017 04072010 laboratory studies performed at the request of the u. Heparin sodium injection, sterile solution, usp trade name. Candidate x, 07330, was accepted by the usp as the usp heparin standard for assay, lot. Product name heparin sodium injection, usp synonyms none 2. Bd diagnostics preanalytical systems product catalog bd.
Pharmaceutical product used as anticoagulant agent details of the supplier of the safety data sheet 2. United states pharmacopeial convention 2014 usp 37 official. Dissolve or dilute a measured quantity of heparin sodium in ph 8. To prepare for this revision, heparin sodium brp has been recalibrated in a collaborative study, to be used with the new methods. Tubex heparin sodium injection, usp is a sterile solution.
As a medication it is used as an anticoagulant blood thinner. Heparin labeling changes on may 1, 20, manufacturers will be required to change labels of heparin sodium injection, usp and heparin lock flush solution, usp to express total drug content. Heparin sodium injection, usp is available in the following concentrationsml. Class modeling analysis of heparin h nmr spectral data. Heparin, also known as unfractionated heparin ufh, is a medication and naturally occurring glycosaminoglycan. 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. Heparin sodium injection is a sterile solution of heparin sodium in water for injection. Product monograph heparin sodium injection usp for intravenous or subcutaneous use usp units per ml 10 000 usp units per ml anticoagulant pfizer canada inc. The potency is determined by a biological assay using a usp reference standard based on units of heparin activity per milligram. Heparin sodium injection, usp is a sterile, nonpyrogenic solution of heparin sodium derived from porcine intestinal mucosa in water for injection. Mixture relevant identified uses of the substance or mixture and uses advised against intended use. Food and drug administration fda have shown that heparin sodium, usp.
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. Heparin sodium sodium chloride benzyl alcohol usp units 8. Standard solutions dilute an accurately measured volume of usp heparin sodium rs with ph 8. Jun 09, 2016 for us marketed heparin, the changes to the usp heparin sodium monograph in 2008, 2009 and 2014 enhanced the quality of this drug by improved detection of contamination, reducing impurity levels and establishing identity tests that are sensitive to the structure and composition of the drug 19. Purified heparin produced in accordance with the guideline for monitoring crude heparin for quality. Identification rs in water to each of a series of suitable plastic tubes placed in a system suitability solution. It is composed of polymers of alternating derivations of. The potency of heparin sodium, calculated on the dried basis, is. The 2014 usp 37 nf 32, and its supple ments, interim revision announcements iras and revision bulletins to that edition, will be official until may 1, 2015, at which time the usp 38nf 33 becomes official. Heparin sodium injection, usp 2000 and 2500 usp unitsml heparin sodium addvantage vial.
Add to each tube 2550 l of in terms of usp heparin units. 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. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. 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. Hydrochloric acid andor sodium hydroxide may have been added for ph adjustment 5. Heparin sodium injection, usp sagent pharmaceuticals. Each container contains 0, 12500, 20000 or 25,000 usp heparin units.
Usp updates heparin sodium monograph pharmaceutical technology. If the platelet count falls below 100,000mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for hit and hitt, and, if necessary. It is to be administered by intravenous or deep subcutaneous routes. It is given by injection into a vein or under the skin. The uspnf, whicn is released on november 1 of each year, becomes official on may 1 of the following year. Pdf usp compendial methods for analysis of heparin. The chemical shifts for heparin and usp heparin sodium reference standard and canoversulfated chondroitin sulfate in the system be independent of international units. Reconstitute the entire contents of an ampule of usp heparin sodium for assays rs with water, and dilute with ph 8. In response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin.
Question and answers about changes to the usp heparin. Sep, 2012 in response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. When necessary, the ph of heparin sodium injection is adjusted with hydrochloric acid andor sodium hydroxide.
For us marketed heparin, the changes to the usp heparin sodium monograph in 2008, 2009 and 2014 enhanced the quality of this drug by improved detection of contamination, reducing impurity levels and establishing identity tests that are sensitive to the. Sixmonth implementation guideline the united states pharmacopeianational formulary and its supplements become official six months after being released to the public. Food and drug administration fda have shown that heparin sodium, usp heparin made under the new united states pharmacopeia. Wyeth pharmaceuticals and esi lederle have recalled all lots of heparin sodium injection, usp porcine derived units per ml, 1ml dosette vial, 10ml and 30ml multiple dose vials, due to. Effective may 1, 20, a new usp labeling standard for heparin sodium injection, usp and heparin lock flush solutions, usp was implemented.
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. In addition, the impact of this recalibration has been assessed by heparin manufacturers. Heparin sodium injection heparin lock flush solution. Other uses include inside test tubes and kidney dialysis machines. Dissolve or dilute an accurately measured quantity of heparin sodium in ph 8. Heparin sodium heparin sodium injection heparin lock flush solution lamivudine lamivudine and zidovudine tablets levofloxacin tablets lidocaine ointment. Usp heparin sodium molecular weight calibrant reference standard by. Dglucosamido nsulfated osulfated or nacetylated and osulfated uronic acid. Product monograph heparin sodium injection usp pdf. The unit for antifactor xa activity is defined by the usp heparin sodium reference standard and change to read. Heparin sodium for assays united states pharmacopeia usp. The us regulatory and pharmacopeia response to the global. Tools for the quality control of pharmaceutical heparin mdpi. Each ml of the 5,000 units per ml preparation contains.
Feb 26, 2019 usually, 7,500 usp units of heparin sodium are added to 100 ml of 0. Revision bulletin heparin 1 official june 18, 2008 heparin sodium tive units are not equivalent see general notices. Anita szajek, phd, and tina morris of usp highlight usps revisions to the heparin sodium monograph in the september 2012 issue of pharmtech. Jun 17, 2008 usp believes that both methods are needed to quickly allow for a qualified supply of heparin and to address the current adulteration of the heparin supply. Question and answers about changes to the usp heparin monograph. May 11, 2018 heparin sodium injection, usp is a sterile, nonpyrogenic solution of heparin sodium derived from porcine intestinal mucosa in water for injection. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from bovine lung tissue, standardized for anticoagulant activity.
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