Crystalline solid form of...

Organic compounds -- part of the class 532-570 series – Organic compounds – Carboxylic acids and salts thereof

Reexamination Certificate

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Reexamination Certificate

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06998503

ABSTRACT:
(2S,5Z)-2-amino-7-(ethanimidoylamino)-2-methylhept-5-enoic acid is crystallized as an anhydrous, stoichiometric 1.5 HCl salt and a scaleable crystallization method is disclosed. The salt form was characterized and the absolute configuration of the chiral center was confirmed as “S”. (2S,5Z)-2-amino-7-(ethanimidoylamino)-2-methylhept-5-enoic acid was high melting and appears acceptably non-hygroscopic for use in a pharmaceutical composition.

REFERENCES:
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patent: 5945408 (1999-08-01), Webber et al.
patent: WO 93/13055 (1993-07-01), None
patent: WO 95/25717 (1995-09-01), None
patent: WO 02/22562 (2002-03-01), None
patent: WO 02/22562 (2002-03-01), None
patent: WO 02/076395 (2002-10-01), None
McInnes et al; J. Exp. Med; 184; 1519; 1996.
Lundberg et al; Lancet; 344; 1673; 1994.
Hamid et al; Lancet; 342; 1510; 1993.
Harold, Mohr, & Tamm; Helvetica Chimica Acta; 66; 2; 744-754; 1983.

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