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Drug-Excipient Compatibility Study

Drug-Excipient Compatibility Studies

Stress Testing per ICH Q1A(R3) Preformulation Screening

Overview Service

Capzer Pharmaceuticals conducts binary and ternary drug-excipient compatibility studies for APIs like Empagliflozin and Gabapentin with formulation excipients using thermal, humidity, and solution stress. Our FDA/DEA-registered cGMP laboratory employs DSC, HPLC, and FTIR to screen interactions supporting prototype selection and ANDA stability predictions.

Study Design

Mixtures (1:1, 1:5 drug:excipient ratios) undergo 40°C/75%RH open dish storage for 4–6 weeks plus solid-state stress (60°C, 50°C/ambient RH).

  • Thermal screening: DSC detects melting point shifts or new exothermic events.

  • Chemical: HPLC monitors assay/degradation products pre/post-stress.

  • Physical: Visual, FTIR for polymorphism changes.

Key Capabilities

  • Excipients screened: Microcrystalline cellulose, lactose, magnesium stearate, SLS, PEGs.
  • Solution compatibility: 0.1N HCl, pH 6.8 buffer, 3% H2O2 at 60°C/24h.
  • Ranking: Compatible (≤5% degradation), borderline (5–10%), incompatible (>10%).

Benefits for Partners

Partners de-risk Empagliflozin tablet formulations with data packages identifying stable excipient combinations, accelerating pilot batch success from our ISO 17025 facility.

Other Service

Need for help?

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.

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