Batch release testing serves as the critical final checkpoint in pharmaceutical quality assurance, validating that each manufactured batch meets stringent regulatory and product specifications before it reaches the market. At Abiozen, our batch release protocols ensure the safety, identity, purity, and efficacy of pharmaceutical products, reinforcing trust across regulatory agencies and global markets.

Full-Spectrum Analysis

Our testing covers the full product lifecycle, from raw materials to final dosage forms. This includes identity confirmation of active pharmaceutical ingredients (APIs) and excipients, impurity profiling to assess purity, potency assays to ensure therapeutic effectiveness, and microbial and endotoxin evaluations to verify safety. This comprehensive analytical coverage guarantees that every batch is thoroughly evaluated and fit for distribution.

Compliance with Global Pharmacopeial Standards

All batch release procedures are aligned with major global pharmacopeial requirements, including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). This ensures smooth regulatory acceptance across international markets and minimizes the need for redundant testing during product registration or importation.

Industry Alignment

Drawing from industry leaders like Curia Global and Thermo Fisher Patheon, Abiozen incorporates best practices in high-throughput testing and globally harmonized quality systems. Our streamlined release processes are engineered to support rapid turnaround without compromising compliance, making us a dependable partner for fast-paced, quality-driven pharmaceutical supply chains.