问卷式审评模板（QBR)-）OGD_Model_QOS_IR_Tablet.pdfVIP

1 EXAMPLE QUALITY OVERALL SUMMARY 2.3 Introduction to the Quality Overall Summary Proprietary Name of Drug Product: Non-Proprietary Name of Drug Product: Ersatzine Tablets, USP Non-Proprietary Name of Drug Substance: Ersatzine Company Name: ANDA Sponsor Dosage Form: Immediate Release Tablets Strength(s): 2 mg Route of Administration: Oral Proposed Indication(s): Depression 2.3.S DRUG SUBSTANCE 2.3.S.1 General Information What are the nomenclature, molecular structure, molecular formula, and molecular weight? Chemical Name: [full chemical name] CAS #: [CAS#] USAN: Ersatzine Molecular Structure: [chemical structure] Molecular Formula: C H O N x y z Molecular Weight: 300 What are the physicochemical properties including physical description, pKa, polymorphism, aqueous solubility (as function of pH), hygroscopicity, melting points, and partition coefficient? Physical Description: Ersatzine is a white, crystalline powder, practically insoluble in water at pH 7.0, freely soluble in methylene chloride, sparingly soluble in acetone and alcohol. pKa : The pKa of the secondary amine group in Ersatzine is 5.5. Polymorphism: There are two anhydrous polymorphic forms, Forms I and II, and no known hydrate forms. Form I is the most stable form and is used for the manufacture of the drug product. Form I and II can be produced by crystallization from ethanol at different cooling rates. Solubility Characteristics: The aqueous solubility as a function of pH at 37º C is: 1 This Quality Overall Summary does not contain real data and information and is meant only to demonstrate examples of information/data/tests that may be used for scie