Our Commitment to Quality HPLC API Purification Services
Precision Peptide Purification
At Zeptide Pharma, we specialize in the isolation and purification of GLP-1 and GIP receptor agonists. Our Reverse-Phase HPLC (RP-HPLC) platforms are optimized to remove closely related impurities, truncated sequences, and trifluoroacetate (TFA) counter-ions, ensuring a final product that exceeds 99% purity specifications.
Key Service Features:
- Scalable Preparative HPLC: From gram-scale clinical trials to multi-kilogram commercial API manufacturing.
- High-Resolution Fractionation: Advanced column chromatography techniques to achieve maximum yield without compromising molecular integrity.
- Method Development & Validation: Custom analytical method validation according to ICH Q2(R1) guidelines to support your Regulatory Filing (DMF/ASMF).
State-of-the-Art GMP Clean Room Environment
All purification and post-purification processing—including lyophilization (freeze-drying) and primary packaging—take place within our ISO Class 5 (Class 100) clean room suites.
- Environmental Monitoring: Continuous tracking of particulates, pressure, and humidity to mitigate the risk of cross-contamination.
- Sterile API Processing: Specialized protocols for endotoxin control and bioburden reduction, essential for injectable peptide therapeutics.
- Qualified Equipment: Our systems undergo rigorous IQ/OQ/PQ (Installation, Operational, and Performance Qualification) to meet global health authority requirements.
Comprehensive Quality Assurance (QA) & Control
Our Quality Control (QC) laboratory utilizes ultra-high-performance liquid chromatography (UHPLC) and Mass Spectrometry (LC-MS) to verify:
- Peptide Mapping & Identity
- Residual Solvent Analysis (per ICH Q3C)
- Stability Testing under accelerated and long-term conditions.
Why Choose Zeptide Pharma?
By integrating high-throughput HPLC purification with a robust GMP quality management system, we reduce lead times and optimize the cost of goods for your Tirzepatide API production. Our technical expertise in peptide chemistry ensures that even the most challenging hydrophobic profiles are managed with precision.