Services: Isolation Services
Impurity Isolation and Profiling
An essential element of quality control for agrochemical and pharmaceutical products is impurity isolation, characterization and profiling. By determining the impurity profile, you can manage manufacturing control and track batch to batch consistency. The isolated impurities are also be used for determination of product safety through determination of individual component toxicity.
The first step in impurity isolation is to analyze your product and determine which impurities to targeted for isolation. Through high-quality analytics, you can confidently identify all essential targets, minimizing expenses while ensuring that you don’t miss any components that will be deemed necessary for product certification.
To produce quality data like toxicological studies or batch analysis, it is important to start with high purity isolates. With nearly two decades of dealing with the complex problems of impurity isolation, we have the expertise to approach even the most difficult impurity isolation request. For the product characterization and certification, we work with top laboratories to acquire high-quality data for NMR, mass spectrometry, UV-VIS, and any additional analytics required. Our highly experienced team of structural elucidation and characterization chemists is there to help positively identify your compounds with aboslute confidence.
Impurity Profiling Highlights
With the ever-increasing demands of regulatory bodies, documentation and certification of products is becoming increasingly complicated.
Planta Analytica has been supporting agrochemical companies with their product registrations since 2006. Let us help you prepare your product registration submission and avoid any delays when certifying your product for market.
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
Although impurity isolation broadly falls under the small molecule isolation umbrella, it has its own distinctive challenges. The starting concentrations of the targets are usually between 0.05% and 0.5%, making them too low for conventional chromatographic techniques. The concentrations of the impurities must be increased 10-50X before conventional preparative chromatographic techniques become economically viable. This typically requires at least three unique enrichment stages. These early-stage operations are often time consuming and difficult because of the large volumes and masses relative to the low quantities of the targeted compounds.
Additionally, when dealing with bacterially derived products, such as agrochemicals like avermectins and emamectins, the products comprise a single major component with multiple closely related structures. The structural similarity between the main components and impurities, as well as their large disparity in concentration, further increases the difficulty to resolve and enrich 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.
