Miljöpåverkan
Heparin
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Detaljerad miljöinformation
The active ingredient in Heparin LEO® is heparin sodium. Heparin sodium is a polysaccharide (carbohydrate) – see Enclosure 1.
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals, vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment (EMA, 2006).
Therefore, no environmental information is required.
Enclosure 1 Physical and Chemical characteristics
Names
International Nonproprietary Name (INN): Heparin sodium
Chemical description: Heterogeneous mixture of variably sulphated polysaccharide chains composed of repeating units of D-glucosamine and either L-iduronic acid or D-glucoronic acid.
Chemical Abstracts Service (CAS) Number: 9041-08-1
Description:
Physical form: Heparin sodium is a white to creamy-white, amorphous powder, odorless, moderately hygroscopic substance (Kilde and Petersen, 2008).
Structural formula:
Pentasaccharide sequence of Heparin (Antithrombin Binding Site of Heparin):
Molecular formula:
Not known
Relative Molecular Mass:
Mean molecular weight (Mn): 12000-15000 Da
Solubility:
The solubility of heparin in water is approx. 25 w/v%. Soluble in saline solutions. Practically insoluble in alcohol, acetone, benzene, chloroform, ether (Kilde and Petersen, 2008).
pH:
pH of 1% aqueous solution: 5.5-7.5 (Kilde and Petersen, 2008).
Optical rotation:
> 35° (Kilde and Petersen, 2008).
References
I. European Medicines Agency (EMA), 2006. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. EMEA/CHMP/SWP/4447/00 corr 2. 1 June 2006.
II. Kilde HD, Petersen CF, 2008. LEO Pharma A/S. Heparin sodium – Elucidation of Structure and other Characteristics.