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Maleate Crystalline hydrochloride Salt of S - 2 - (1 - iminoetil) amino ethyl - 2 - Methyl L cysteine

机译:S-[2--((1-亚氨基腈)氨基]乙基]-2-甲基L半胱氨酸的马来酸酯盐酸盐

摘要

1. - a Crystalline form of maleate hydrochloride S - [2 - [(1 - iminoetil) amino] ethyl] - 2 - methyl - l-cysteine characterized by at least one of: an x-ray Powder Pattern substantially as shown in fig. 1; a Mass loss of approximately 1 in a temperature range of approx. Imadamente 40oC to approximately 350 F; a Raman Spectrum substantially as shown in fig.5; and an Elementary Analysis substantially as in table 1.2 maleate hydrochloride Crystal form S - [2 - [(1iminoetil) amino] ethyl] - 2 - methyl - L - cysteine of claim 1, in which it accumulates in the form of a Plurality of crystals aglomerados.3.The Crystalline form of the agglomerates of maleate hydrochloride S - [2 - [(1 - iminoetil) amino] ethyl] - 2 - methyl - L - cysteine of claim 2, in which the Plurality of Crystals usually accumulates in packaged form agglomerates ordenadamente.4.A Pharmaceutical composition comprising the maleate hydrochloride S - [2 - [(1 - iminoetil) amino] ethyl] - 2 - methyl - L - cysteine Crystalline claims 1 together with a pharmaceutically acceptable vehicle.
机译:1.-马来酸盐盐酸盐S的结晶形式-[2-[(1-亚氨基腈)氨基]乙基] -2-甲基-1-半胱氨酸,其特征在于以下至少之一:基本如图1所示的x-射线粉末图。 。 1;在约200℃的温度范围内,约有1的质量损失。摄氏40oC至约350 F;基本上如图5所示的拉曼光谱。以及基本上如表1.2所示的马来酸盐酸盐的元素分析,根据权利要求1所述的晶型S- [2-[((1-亚氨基乙腈)氨基]乙基] -2-甲基-L-半胱氨酸),其中其以多个晶体的形式积累3.根据权利要求2所述的马来酸盐盐酸盐S- [2-[(1-亚氨基腈)氨基]乙基] -2-甲基-L-半胱氨酸的附聚物的结晶形式,其中,通常在包装中堆积多个晶体4.一种药物组合物,其包含马来酸盐酸盐S- [2-[(1-亚氨基腈)氨基]乙基] -2-甲基-L-半胱氨酸权利要求1的结晶以及药学上可接受的媒介物。

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