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Contract analytical services – API Pharma Tech

Contract analytical services

We offer wide range of analytical services by adopting robust and validated international methods. Our analytical services support the entire life cycle from early phase drug development, to regulatory submissions and GMP manufacturing, to post marketing analytical testing requirements.

We offer wide range of analytical method development and validation services We utilize our knowledge of method development on hundreds of products to assist with the development process. We evaluate attributes such as precision, linearity, accuracy and specificity during development to ensure the method is suitable for validation.

This is our key area where most of our clients rely on. With desired and accurate maintenance of temperature and humidity, Our chambers are housed in secured areas, continuously monitored by our validated monitoring systems and supported by a fully validated computerized systems.

Extractables and leachables (E/L) studies are critical to the identification and quantification of harmful leachable impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products. Our scientists conduct extractables and leachables studies in accordance with regional guidance, Good Manufacturing Practice (GMP).

The ICH Q3D Guideline for pharmaceutical elemental impurities presents major challenges to testing and risk assessment within the pharmaceutical industry. These challenges are related to the requirement to meet current stringent limits for specific elements as drug product impurities, and to assess patient risk due to exposure to such impurities. Our elemental impurities experts can help you to develop a compliance strategy to achieve successful implementation of ICH Q3D requirements.

Good Manufacturing Practice (GMP) batch release testing is a necessary requirement to ensure high quality pharmaceuticals prior to release for sale, supply or export. Our GMP batch or lot release testing teams apply a wide range of analytical technologies to provide responsive release analytics to ensure that healthcare products meet the product specification. We provide batch and lot release testing for active pharmaceutical ingredients (APIs), and finished products.

Physicochemical testing is an integral requirement of product registration for pharmaceutical products. We offer all the characterization and physicochemical studies (active ingredients and formulated products) necessary to support registration worldwide.

  • HPLC Lab
  • ICP-MS Lab
  • GC Lab
  • Wet Lab
  • Stability Storage Area
  • Weighing Room
  • High Performance Liquid Chromatography (HPLC) Coupled with VWD/RID, DAD – Agilent
  • Inductively coupled plasma mass spectrometry (ICP-MS) – NexION 1000 Perkin Elmer
  • Gas Chromatography with Head Space (GC-HS) – Agilent
  • Ion Chromatography (IC) – Thermo Dionex 5000+
  • Fourier-transform infrared spectroscopy (FTIR)
  • UV-Visible Spectrophotometer
  • Stability Chambers