ChP 2025 vs. USP <1104>: Syringe Testing Guide
A complete comparison of the new Chinese Pharmacopoeia requirements and USP <1104>. Why 0.25N accuracy is the new global benchmark.
The Compliance Challenge
For global pharmaceutical brands, ensuring Prefilled Syringe (PFS) functionality is critical. The standards are evolving, with ChP 2025 (China) and USP <1104> (USA) setting stricter limits.
Key Update: Force Accuracy
1. ChP 2025 (General Chapter 4015)
• Requirement: Specifically mandates a recording accuracy of ±0.25N for rubber stopper puncture force.
• Reason: Legacy 500N sensors with 1% accuracy (±5N error) are no longer sufficient to detect subtle silicone lubrication failures or stopper coring issues.
2. USP <1104> Plunger Motion
• Focus: Distinguishes between "Break-loose Force" (Initial peak) and "Gliding Force" (Sustained mean).
• Compliance: Requires high data sampling rates to capture the millisecond-level initial peak.
The KHT Solution
The KHT MED-01 is engineered for this exact precision gap. By utilizing a specialized 50N High-Precision Sensor, we achieve the ±0.25N accuracy required by ChP 2025, ensuring your PFS data is audit-ready for both NMPA and FDA submissions.
