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From the Cover: Elucidation of crystal form diversity of the HIV protease inhibitor by high-throughput crystallization Sherry L. Morissette, Stephen Souleymane, Douglas Levinson, Michael J. CIA, and
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What is elucidation of crystal form?
Elucidation of crystal form is the process of determining and describing the arrangement and structure of crystals.
Who is required to file elucidation of crystal form?
The companies or individuals who have developed a new polymorphic form of a drug or a new crystal structure are required to file the elucidation of crystal form.
How to fill out elucidation of crystal form?
The elucidation of crystal form should be filled out by providing detailed information about the crystal structure, experimental techniques used for characterization, and any observations or findings regarding the crystal form. It is recommended to consult regulatory guidelines for specific requirements.
What is the purpose of elucidation of crystal form?
The purpose of elucidation of crystal form is to provide scientific evidence and characterization data of a new polymorphic form or crystal structure. This information is crucial for regulatory authorities to evaluate the safety, efficacy, and quality of the drug substance.
What information must be reported on elucidation of crystal form?
The elucidation of crystal form should report information such as crystal structure determination methods, crystallographic data, thermal analysis results, spectroscopic data, and any relevant physical or chemical properties of the crystal form.
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