In response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin. Standard solutions dilute an accurately measured volume of usp heparin sodium rs with ph 8. Heparin sodium injection, usp porcine, preserved with benzyl alcohol, is available as follows. On the basis of comments received on the published and new methods submitted by the industry, it is proposed to. Reconstitute the entire contents of an ampule of usp heparin sodium for assays rs with water, and dilute with ph 8. Hazards identification emergency overview heparin sodium injection, usp, is a solution containing heparin sodium, a heterogeneous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties.
Class modeling analysis of heparin h nmr spectral data. 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. 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. Formation of this complex can result in disruption of the heparinantithrombin iii complex responsible for the anticoagulant activity of heparin. It is to be administered by intravenous or deep subcutaneous routes. Heparin sodium for assays united states pharmacopeia usp. Heparin sodium injection, sterile solution, usp trade name. 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 can interfere with some immunoassays, however. Heparin sodium injection, usp is available in the following concentrationsml. 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. Heparin sodium for assays united states pharmacopeia usp reference standard. If the platelet count falls below 100,000mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for hit and hitt, and, if necessary. Easytoread drug name and dosage strength to aid in identifying the right product. United states pharmacopeial convention 2014 usp 37 official. The potency is determined by a biological assay using a usp reference standard based on units of heparin activity per milligram. Dissolve or dilute an accurately measured quantity of heparin sodium in ph 8. Usp updates heparin sodium monograph pharmaceutical. 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 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.
Usp encourages any manufacturers that have methods for consideration in stage 2 to submit them to dr. Dissolve or dilute a measured quantity of heparin sodium in ph 8. Heparin sodium usp monograph specify that gal may not exceed 1. 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. Sixmonth implementation guideline the united states pharmacopeianational formulary and its supplements become official six months after being released to the public. Heparin sodium injection, usp is a sterile solution of heparin sodium derived from bovine lung tissue, standardized for anticoagulant activity. Protamine, a strongly basic compound, forms complexes with heparin sodium or heparin calcium, which are acidic compounds.
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. Assay of heparin the anticoagulant activity of heparin is determined in vitro by comparing its ability in given. 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. Purified heparin produced in accordance with the guideline for monitoring crude heparin for quality. In addition, the impact of this recalibration has been assessed by heparin manufacturers. Usp heparin sodium molecular weight calibrant reference standard by. 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.
This change from the existing usp requirements is intended to prevent medication errors. 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. Heparin, also known as unfractionated heparin ufh, is a medication and naturally occurring glycosaminoglycan. Hydrochloric acid andor sodium hydroxide may have been added for ph adjustment 5. The potency of heparin sodium, calculated on the dried basis, is. The chemical shifts for heparin and usp heparin sodium reference standard and canoversulfated chondroitin sulfate in the system be independent of international units. Us pharmacopeia announces revised heparin monographs and. Heparin coated blood oxygenators are available for use in heartlung machines. Nlt 20 mgml of usp heparin sodium tion and sample solution in duplicate. Prepare 1% ww usp over water bath set at 37, transfer 120 l of ph 8.
Jun 24, 2014 usp compendial methods for analysis of heparin. Analysis of heparin and lmw heparin, including enoxaparin sodium. 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. The uspnf, whicn is released on november 1 of each year, becomes official on may 1 of the following year. Each ml of the 5,000 units per ml preparation contains. Each container contains 0, 12500, 20000 or 25,000 usp heparin units. Protamine is used therapeutically to reverse the activity of heparins. Other uses include inside test tubes and kidney dialysis machines.
In this application note typical results obtained with the alexys analyzer are reported, demonstrating its performance for the analysis of organic impurities in. Nlt 20 mgml of usp heparin sodium identification rs in deuterium oxide with 0. Pdf usp compendial methods for analysis of heparin. Effective may 1, 20, a new usp labeling standard for heparin sodium injection, usp and heparin lock flush solutions, usp was implemented. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. 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 37nf32 5. Nutescu, pharmd, clinical professor of pharmacy practice at the university of illinois college of pharmacy, stated that. Product monograph heparin sodium injection usp pdf. Product name heparin sodium injection, usp synonyms none 2. Add to each tube 2550 l of in terms of usp heparin units. Heparin sodium injection, usp 2000 and 2500 usp unitsml heparin sodium addvantage vial. The electropherogram of the test solution is test solutionreconstitute an accuratelysimilar to that of the standard solution, and does.
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. Heparin sodium is the sodium salt of sulfatedpackaging and storagepreserve in tight con. Food and drug administration fda have shown that heparin sodium, usp heparin made under the new united states pharmacopeia. Heparin sodium heparin sodium injection heparin lock flush solution lamivudine lamivudine and zidovudine tablets levofloxacin tablets lidocaine ointment. Dglucosamido nsulfated osulfated or nacetylated and osulfated uronic acid. It is composed of polymers of alternating derivations of.
To prepare for this revision, heparin sodium brp has been recalibrated in a collaborative study, to be used with the new methods. Activity approximately 100 unitsmg 25 ku 100 ku 500 ku ku 101932 heparin, sodium salt solution. Revision bulletin heparin 1 official june 18, 2008 heparin sodium tive units are not equivalent see general notices. Chromatographic determination of molecular weight distributions for heparin sodium. Anita szajek, phd, and tina morris of usp highlight usps revisions to the heparin sodium monograph in the september 2012 issue of pharmtech. Heparin sodium injection is a sterile solution of heparin sodium in water for injection. Sep, 2012 in response to the 2008 heparin situation, the united states pharmacopeia convention usp has revised the quality standards for heparin. Candidate x, 07330, was accepted by the usp as the usp heparin standard for assay, lot. Usp updates heparin sodium monograph pharmaceutical technology. May 11, 2018 heparin sodium injection, usp is a sterile, nonpyrogenic solution of heparin sodium derived from porcine intestinal mucosa in water for injection. Question and answers about changes to the usp heparin.
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. 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. Question and answers about changes to the usp heparin monograph. Heparin is a heterogenous group of straightchain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties.
It is given by injection into a vein or under the skin. Tubex heparin sodium injection, usp is a sterile solution. Specifically it is also used in the treatment of heart attacks and unstable angina. As a medication it is used as an anticoagulant blood thinner. Heparin sodium sodium chloride benzyl alcohol usp units 8. Aug 03, 2017 04072010 laboratory studies performed at the request of the u. Identification rs in water to each of a series of suitable plastic tubes placed in a system suitability solution. Tools for the quality control of pharmaceutical heparin mdpi. 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. Feb 26, 2019 usually, 7,500 usp units of heparin sodium are added to 100 ml of 0. 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.
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. Heparin sodium injection, usp sagent pharmaceuticals. Heparin sodium injection, usp is a sterile, nonpyrogenic solution of heparin sodium derived from porcine intestinal mucosa in water for injection. Food and drug administration fda have shown that heparin sodium, usp. Usually, 7500 usp units of heparin sodium are added to 100 ml of 0. Purchase heparin sodium for assays reference standard, 9.
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. Heparin sodium injection heparin lock flush solution. This sixmonth implementation timing gives users more time to bring their methods and procedures into compliance. Bd diagnostics preanalytical systems product catalog bd. As lithium heparin is usually used, a persons lithium levels cannot be obtained from these tubes. Usually, 7,500 usp units of heparin sodium are added to 100 ml of 0.