Impurity Isolation and Profiling

Impurity isolation, characterization, and profiling are critical aspects of quality control in agrochemical and pharmaceutical products. Establishing a comprehensive impurity profile enables manufacturers to maintain rigorous production control and ensure batch-to-batch consistency. Additionally, isolated impurities play a vital role in assessing product safety by facilitating the evaluation of individual component toxicity.

The initial phase of impurity isolation involves a comprehensive analysis of the product to identify and prioritize impurities for targeted isolation. Utilizing high-precision analytical techniques ensures accurate identification of all critical components, optimizing resource allocation while maintaining compliance with product certification requirements

Generating high-quality data for applications such as toxicological studies and batch analysis requires the use of high-purity isolates as a foundation. With nearly two decades of expertise in addressing complex impurity isolation challenges, we have the capability to tackle even the most demanding isolation requests. For product characterization and certification, we collaborate with leading laboratories to obtain high-precision data through advanced analytical techniques, including NMR, mass spectrometry, UV-Vis spectroscopy, and any additional methods required. Our highly experienced team of structural elucidation and characterization chemists ensures the definitive identification of compounds with absolute confidence.

Impurity Profiling Highlights

As regulatory requirements continue to evolve, the documentation and certification process for products has become increasingly complex.

Since 2006, Planta Analytica has been a trusted partner for agrochemical companies, assisting with product registration and ensuring compliance with industry standards. Our expertise in regulatory documentation can help streamline your submission process, minimizing delays and facilitating smooth market certification

Sensitivity Analysis for Low Concentration Targets

Development of high-resolution analytical methods to determine with certainty which impurities exceed the minimum threshold as set by the regulatory agency.

Structure Elucidation

Expert-tier data interpretation and structural elucidation services for accurate characterization of your impurities.

Semi & Fully Synthetic Production of Targets

Production of difficult to isolate targets as well as degradation products for fulfillment of fate study requirements.

Comprehensive Reporting & Documentation

High-quality and comprehensive reports that satisfy the stringent requirements of regulatory agencies.

Not just Any isolation

Impurity isolation, while categorized under small molecule isolation, presents distinct challenges due to the exceptionally low starting concentrations of target compounds—typically ranging between 0.05% and 0.5%. At these levels, conventional chromatographic techniques are ineffective, requiring a 10- to 50-fold concentration increase before preparative chromatography becomes economically feasible. Achieving this necessitates at least three distinct enrichment stages. These early-phase processes are often labor-intensive and complex, involving large sample volumes and masses relative to the minute quantities of the targeted impurities.

Further complications arise when isolating impurities from bacterially derived products, such as agrochemicals including avermectins, emamectins, and spinosyns. These substances typically consist of a single major component accompanied by multiple structurally similar impurities. The combination of structural resemblance and extreme concentration disparity significantly increases the difficulty of resolving and enriching the impurities.

Analytical Support

Impurity Profiling

With the impurities isolated and fully characterized, your product can be fully profiled and qualified. Planta Analytica will work with you to prepare analytical methods that meet the regulatory requirements.

Batch Analysis

In addition to impurity profiling, Planta Analytica can help you with standardizing and certifying your products based around its actives. Support your manufacturing and QC teams with routine five batch analysis and similar services.