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Heparin TAP Report

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Heparin TAP Report CFNP TAP Review Heparin 8/16/2002 HEPARIN Livestock Executive Summary Heparinic acid, or heparin, is highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. Heparin occurs in and is obtained from liver, lung, mast cells, etc., of vertebrates. Its function is unknown, but in humans it is used to prevent blood clotting in vivo and in vitro, in the form of many different salts. 1 The subject of the petition is a request for heparin to be approved for use in organic livestock medical treatment. Heparin is used in blood transfusions to prevent the donor’s blood from coagulating prior to administration, as well as in animals at risk of thrombosis due to endotoxemia and disseminated intravascular coagulopathy. Summary of TAP Reviewer Analyses 2 Synthetic/ Allow without restrictions? Allow only with restrictions? (See Reviewers’ Nonsynthetic comments for restrictions) Synthetic (3) Yes (1) No (2) No (2) Identification Chemical names: Heparin, Heparinic acid Other Names: Calcilean, Calciparine, Hepalean, Heparin Leo, Liquaemin Bemiparin, CY 216, CY 222, Certoparin, Clexane, Clivarin, Clivarine, Dalteparin, Enoxaparin, Eparina [DCIT], FR 860, Fluxum, Fragmin A, Fragmin B, Fraxiparin, Hed-heparin, Heparin CY 216, Heparin sulfate, Heparina [INN- Spanish], Heparinate, Heparine [INN-French], Heparinum [INN-Latin, Hepathrom, KB 101, Lipo-hepin, Liquemin, Multiparin, Novoheparin, OP 386, OP 622, Pabyrin, Parnaparin, Parvoparin, Pularin, Reviparin, Sandoparin, Sublingula, Thromboliquine, Vetren, Vitrum AB, alpha-Heparin, depo-Heparin CAS Number: #9005-49-6 Other numbers: EINECS #232-681-7 HSDB #3094 NIOSH: MI0700000 RTECS Number : MI0850000 1 “Heparin.” ChemID Plus. http://toxnet.nlm.nih.gov/cgi-bin/sis/search 2 This Technical Advisory Panel (TAP) review is based on the information available as of the date of this review. This review addresses the requirements of the Organic Foods Production Act to the best of the investigator’s ability, and has been reviewed by experts on the TAP. The substance is evaluated against the criteria found in section 2119(M) of the OFPA [7 USC 6517(m)]. The information and advice presented to the NOSB is based on the technical evaluation against that criteria, and does not incorporate commercial availability, socio-economic impact, or other factors that the NOSB and the USDA may want to consider in making decisions. CFNP TAP Review Heparin 8/16/2002 VA Classification: PrimaryBL110 Characterization Composition/Structure: Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, that has anticoagulant properties. Although other sugars may be present, the main sugars occurring in heparin are: (1) a-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-a-D-glucose 6-sulfate, (3) b-D-glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose, and (5) a-L- iduronic acid. l. Heparin.3 These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. For unfractionated standard heparin, molecular weight ranges from 5,000 to 30,000 Da, and for low molecular weight heparin (LMWH) it ranges from 4,000 to 6,000 Da (Ramos- Sanches et al., 1995). Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. Heparin is synthesized endogeneously and stored in the basophilic granules of mast cells, which are found in most tissues of mammalian species. The greatest concentrations are found in the liver, lung and intestines. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin may also be a salt of calcium. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is administered by an intravenous or deep subcutaneous route. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. 4, 5 Properties: Appearance: White powder. Odor: Odorless. Solubility: Soluble in water. pH: 6.0-7.5 (1% aqueous solution) % Volatiles by volume @ 21C (70F): 0 Vapor Pressure (mm Hg): 0 @ 20C (68F) Evaporation Rate (BuAc=1): 0 Stability: Stable under ordinary conditions of use and storage. Hygroscopic. Hazardous Decomposition Products: Burning may produce carbon monoxide, carbon dioxide, sulfur oxides, and 3 “Heparin – General Information.” BioIberica. http://www.bioiberica.com/eng/mp/heparin.htm 4 “Heparin – Rx List Monograph.” RxList.com http://www.rxlist.com/cgi/generic/heparin.htm 5 “Heparin Sodium – General Information.” BioIberica. http://www.bioiberica.com/eng/mp/heparines.htm 2 CFNP TAP Review Heparin 8/16/2002 nitrogen oxides. Hazardous Polymerization: Will not occur. Incompatibilities: Strong oxidizers. Conditions to Avoid: Heat, flames, ignition sources and incompatibles. 6 Protein binding: Very high; primarily to low-density lipoproteins; also bound to globulins and to fibrinogen. Biotransformation: Hepatic; however, the primary route of removal from the circulation is uptake by the reticuloendothelial system. Half-life: 1 to 6 hours (average 1.5 hours); dose and route dependent and subject to inter- and intrapatient variation. May be increased above the average in patients with renal failure, hepatic function impairment, or obesity. May be decreased in patients with pulmonary embolism, infections, or malignancy. Onset of action: Direct intravenous injection - Immediate. Intravenous infusion - Immediate when infusion is preceded by the recommended intravenous loading dose. If no loading dose is given, the onset of action may depend upon the rate of infusion. Subcutaneous - Generally within 20 to 60 minutes but subject to interpatient variability. Elimination: Renal, usually as metabolites. However, after intravenous administration of high doses, up to 50% of a dose may be excreted unchanged. In dialysis - Not removed via hemodialysis.7 How Made: Heparin may be derived from porcine intestinal mucosa or bovine intestinal or lung tissue in an extraction process. However, since the outbreak of bovine spongiform encephalopathy (BSE), or mad cow disease, only porcine- derived heparin is allowed in the United States and Europe. Crude heparin is obtained during the extraction phase of the intestinal mucosa, involving a proteolytic treatment of the tissue followed by extraction and complexing with ion pairing reagents. The crude heparin is subjected to fractional precipitation, purification, and chemical treatment to obtain injectable heparin. 8 The following is general information on biological and natural extraction, from the EPA: 3.4.2.2 Biological and Natural Extraction Many materials used as pharmaceuticals are derived from such natural sources as the roots and leaves of plants, animal glands, and parasitic fungi. These products have numerous and diverse pharmaceutical applications, ranging from tranquilizers and allergy-relief medications to insulin and morphine. Also included in this group is blood fractionation, which involves the production of plasma and its derivatives. Despite their diversity, all extractive pharmaceuticals have a common characteristic: they are too complex to synthesize commercially. They are either very large molecules, and/or their synthesis results in the production of several stereoisomers, only one of which has pharmacological value. Extraction is an expensive manufacturing 6 “Heparin Na – MSDS.” Mallinckrodt Baker, Inc. 8 May 2000. http://www.jtbaker.com/msds/h0314.htm 7 “Heparin Leo: USPDI Professional Information.” Drugs.com. http://drugs.com/xq/cfm/pageID_0/xml_001310/type_pros/bn_Heparin%20Leo/qx/index.htm# 8 “Risk of transmission of new variant Creutzfeldt-Jakob disease: tests developed to guarantee the safety of an injectable medicine, heparin.” Institut National de la Recherche Agronomique. September 2001. http://www.inra.fr/presse/sept01/gb/nb1.htm 3 CFNP TAP Review Heparin 8/16/2002 process which requires collecting and processing large volumes of specialized plant or animal matter to produce small quantities of products. Facilities utilize extraction when there are no other reasonable alternatives for producing a desired active ingredient. The extraction process consists of a series of operating steps beginning with the processing of a large quantity of natural or biological material containing the desired active ingredient. After almost every step, the volume of material being handled is reduced significantly. In some processes, reductions may be in orders of magnitude, and complex final purification operations may be conducted on quantities of materials only a few thousandths of the volume handled in earlier steps. Neither continuous processing methods nor conventional batch methods are suitable for extraction processing. Therefore, a unique assembly-line, small-scale batch processing method is used. Material is transported in portable containers through the plant in 75- to 100-gallon batches. A continuous line of containers is sent past a series of operating stations. At each station, operators perform specific tasks on each batch in turn. As the volume of material being handled decreases, individual batches are continually combined to maintain reasonable operating volumes, and the line moves more slowly. When the volume is reduced to a very small quantity, the containers also become smaller, with laboratory-size
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