Registration Dossier
Registration Dossier
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EC number: 618-944-2 | CAS number: 93413-69-5
Additional physico-chemical information
Administrative data
Link to relevant study record(s)
Description of key information
The study (Wyeth, 1991) fell into hygroscopicity, intrinsic dissolution rate and polymorphic crystal form comparison.
At room temperature (23℃), the test substance is essentially non-hygroscopic.
The intrinsic dissolution rate was found to be essentially unaffected by pH in the pH range of 1-8 and was found to be approximately 3.5E-04 g/cm2-sec. The results suggest that no dissolution rate-limiting absorption should occur.
The test substance was found to exist in at least three polymorphic forms. Form I and Form II have been producted from synthetic procedures. From III has only been formed by sulimation of Form I at high temperatures under atmospheric pressure. At 150℃, Form II is more stable than Form I and is the acceptable form for all development and production purposes. Form I and Form II are equal in terms of aqueous solubility, intrinsic dissolution rate and hygroscopicity.
Additional information
The study (Wyeth, 1991) fell into hygroscopicity, intrinsic dissolution rate and polymorphic crystal form comparison.
At room temperature (23℃), the test substance is essentially non-hygroscopic.
The intrinsic dissolution rate was found to be essentially unaffected by pH in the pH range of 1-8 and was found to be approximately 3.5E-04 g/cm2-sec. The results suggest that no dissolution rate-limiting absorption should occur.
The test substance was found to exist in at least three polymorphic forms. Form I and Form II have been producted from synthetic procedures. From III has only been formed by sulimation of Form I at high temperatures under atmospheric pressure. At 150℃, Form II is more stable than Form I and is the acceptable form for all development and production purposes. Form I and Form II are equal in terms of aqueous solubility, intrinsic dissolution rate and hygroscopicity.
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