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Storage condition (25° C, 30° C & 40° C)

Stability Storage Conditions

ICH Long-term, Intermediate & Accelerated per Q1A(R3)

Overview Service

Capzer Pharmaceuticals provides cGMP stability storage and testing at 25°C/60%RH, 30°C/65%RH, and 40°C/75%RH in continuously monitored chambers with 1000 cu. ft. capacity and backup power. Our FDA/DEA-registered facility supports ICH protocols for Gabapentin commercial batches and Empagliflozin ANDA stability through 60 months.

ICH Storage Conditions

Standard zones meet global Zone II-IV requirements with calibrated data loggers (±2°C/±5%RH).

  • Long-term (25°C/60%RH): General case, 12+ months minimum for room temperature labeling.

  • Intermediate (30°C/65%RH): Required if accelerated fails, 6–12 months data.

  • Accelerated (40°C/75%RH): 6 months minimum to predict shelf-life via Arrhenius modeling.​

Key Capabilities

  • Photostability (ICH Q1B Option 2) with xenon/UV exposure.
  • Pull schedules: 0, 3, 6, 9, 12, 18, 24, 36 months per protocol.
  • Full testing: Assay, impurities, dissolution, microbial limits at each interval.

Benefits for Partners

Partners secure three-zone data packages from our ISO 17025 lab supporting 24–36 month shelf-lives for Zone IV markets and rapid Empagliflozin registration timelines.

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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