Five Batch Analysis

Five-batch analysis is a critical requirement for ensuring that substances meet the 98% w/w purity level mandated by regulatory authorities for successful registration. This process involves a comprehensive examination of multiple production batches to detect, identify, and quantify any impurities present. Over the past decade, our laboratory has honed its expertise in the separation, identification, synthesis, and quantification of trace impurities, ensuring that products comply with international regulatory standards. Equipped with state-of-the-art instrumentation—including NMR (300, 400, and 700 MHz), analytical and preparative HPLC, UPLC, UPLC-MS, GC-MS, UV-Vis, spectrofluorimetry, and a modern ATR system—our facility offers a full spectrum of analytical techniques for robust impurity profiling.

Our Process

1. Pre-Screening of 5 Batches

Each batch undergoes initial screening to detect and estimate impurity levels, providing a preliminary overview of the substance’s purity status.

2. Impurity Identification and Structure Elucidation

Working closely with the sponsor, our team uses advanced spectroscopic (NMR, UV, IR) and chromatographic (HPLC, UPLC-MS, GC-MS) methods to pinpoint and characterize unknown impurities.

3. Isolation and/or Synthesis of Impurities

If necessary, identified impurities are isolated in sufficient quantities or synthetically produced, enabling precise reference standards and facilitating accurate quantification during analysis.

4. Comprehensive Analysis Using Validated Methods

Each of the five batches is tested with rigorously validated protocols to confirm active ingredient content and detect any impurities down to very low levels.

5. Characterization of Commercial Batches

In parallel, five commercial batches are characterized in detail alongside reference standards via UV, IR, NMR, LC-MS/MS, and/or GC-MS, as applicable.

All work is conducted in strict accordance with global regulatory directives, reinforcing the integrity and credibility of the final data. By combining advanced analytical tools, specialized expertise in impurity chemistry, and a commitment to compliance, our laboratory provides reliable, high-quality results that support successful product registration and ongoing quality assurance.