Crystal form of Treprostinil sodium salt and preparation method therefor
AssigneeShanghai Forefront Pharmceutical Co., Ltd.
InventorsWei Li, Yi Ren
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Abstract
Disclosed are a new crystal form of treprostinil sodium salt (the structural formula thereof is shown as formula I) and a preparation method therefor. Specifically, disclosed are a five and half hydrates of the treprostinil sodium salt and some dehydrated crystal forms thereof. The new crystal form has better stability and hygroscopicity. As a treprostinil crude drug, the new crystal form can meet the requirements for storage and loading and transportation, is stable in terms of quality and can guarantee the controllable quality of subsequent preparation products.
Claims8
A five-and-a-half hydrate of Treprostinil sodium salt, or a hydrate partially dehydrated crystal form II thereof,
- wherein the powder X-ray diffraction (Cu-Ka, 1.54178 Å) pattern of the five-and-a-half hydrate of Treprostinil sodium salt has characteristic peaks at the following 2Theta angle positions:
- 4.3°±0.2°, 8.7°±0.2° and 17.6°±0.2°;
- and
- the powder X-ray diffraction (Cu-Ka, 1.54178 Å) pattern of the hydrate partially dehydrated crystal form II of the five-and-a-half hydrate of Treprostinil sodium salt has characteristic peaks at the following 2Theta angle positions:
- 5.3°±0.2°, 10.6°±0.2° and 16.0°±0.2°.
Dependencies are inferred from the claim text.