Analytical services

Product description

  • ChemCon's wide range of analytical services includes: Method development and method validation, identity, quantitative and limit tests, reference/ impurity standard qualification, ICH compliant stability studies. All the equipment used for QC including NMR spectrometry is fully qualified for cGMP with DQ-IQ-OQ-PQ. It can provide full or partial QC analysis of customer samples using out extensive range of analytical instrumentation. Analytical instrumentation includes: NMR: 400 MHz, Bruker, multinuclear, HPLC: DAD, UV-, RI- and ELS-detectors, GPC, LC-MS etc.
  • Stability programs are an important part of any drug development program. At ChemCon we perform these studies in-house according to ICH guidelines. Storage, analytical tests and documentation are all in one hand. ChemCon offers long-term storage under all common as well as customary conditions according to ICH guidelines on both APIs and drug products. Accompanying the stability program it performs impurity studies and forced degradation studies. These are performed according to the customers' needs and typically include: Thermal stress, oxidative/ reductive stress, acidic and alkaline stress, light stress.
  • Validation: In order to comply with regulatory requirements, close attention to every detail is needed to ensure everything performs according to specifications. ChemCon pays special attention to equipment qualification and process validation to provide full regulatory compliance for the clients. It strictly adheres to applicable guidelines, performs the most rigorous testing and executes studies in a timely fashion to ensure that the product is of the highest possible quality. Development of QC methods is an integral part of all project stages. ChemCon has extensive experience in developing methods for the customers needs. Typically these include: Process validation, method validation, QC tests of final products, intermediates and raw materials, QC tests of API, intermediates and raw materials, impurity identification, qualification of standards.
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