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Physicochemical Characterization
APIs & Excipients per ICH Q6A Preformulation
Capzer Pharmaceuticals determines chemical identity, solid-state properties, and solution behavior for APIs like Empagliflozin (C23H27ClO7, 450.91 g/mol) and Gabapentin plus excipients. Our FDA/DEA-registered cGMP laboratory uses HPLC, DSC, XRPD, and Karl Fischer to generate data supporting formulation design and ANDA specifications.
Complete monograph compliance verifies structure and purity.
Molecular formula/weight, CAS number, elemental analysis.
pKa, logP (1.7 for Empagliflozin), partition coefficient.
Solubility profiles: pH 1.2–8.0, cosolvents, biorelevant media.
Solid-state and bulk characteristics guide processing.
Particle size/shape (laser diffraction, SEM), polymorphism (XRPD, DSC).
Hygroscopicity (DVS), flowability (Carr’s index), bulk/tapped density.
Thermal: Melting point, glass transition, decomposition onset.
Partners receive comprehensive profiles for Empagliflozin tablet prototypes from our ISO 17025 facility, enabling robust QbD formulation and 24-month stability predictions.
Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.