Miljöpåverkan
Tinzaparin
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Detaljerad miljöinformation
The active ingredient in Tinzaparin LEO® is tinzaparin sodium. Tinzaparin sodium is a polysulphated and acetylated glucosaminoglycane sodium salt (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): Tinzaparin sodium
Chemical description: The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulpho-D glucosamine structure at the reducing end of their chain.
Chemical Abstracts Service (CAS) Number: 9041-08-1.
Description:
Physical form: Tinzaparin sodium is a white to almost white, amourphous powder, moderately hegroscopic substance. (Herr and Agerholm, 2011).
Structural formula:
Molecular formula:
C60H77N5S12O85Na16 to C122H159N10S23O169Na31
Relative Molecular Mass:
From 2,979 to 5,916 Da
Solubility:
The solubility of tinzaparin sodium in water is >50 w/v%. Soluble in saline solutions. Practically insoluble in ethanol, acetone, benzene, chloroform, ether (Herr and Agerholm, 2011).
pH:
pH of 1% aqueous solution: 5.5-8.0 (Herr and Agerholm, 2011).
Optical rotation: > 35° (Herr and Agerholm, 2011).
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. Herr SO, Agerholm C, 2011. LEO Pharma A/S. Tinzaparin sodium – Elucidation of Structure and other Characteristics.