HPLC Purification Services for APIs

Zeptide Pharma provides industry-leading preparative HPLC drug purification services, specifically engineered for complex synthetic peptides and Large Molecule Active Pharmaceutical Ingredients (APIs). Our facility operates under strict current Good Manufacturing Practice (cGMP) standards to ensure the highest levels of purity, safety, and regulatory compliance for your clinical and commercial pipelines.

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 designed to achieve maximum yield without compromising molecular integrity.
  • Method Development & Validation: Custom analytical method validation according to ICH Q2(R1) guidelines to support regulatory filings, including DMF and ASMF submissions.

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: All systems undergo rigorous IQ/OQ/PQ (Installation, Operational, and Performance Qualification) procedures 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 exceptional precision and consistency.

Contact Zeptide Pharma today to discuss your project requirements and request a technical consultation for your purification needs.