Analytical Development

Analytical Development in Pharma

Analytical development plays a critical role in regulatory compliance, as regulatory agencies require that pharmaceutical companies provide evidence of the quality, safety, and efficacy of their products. Analytical methods must therefore be validated according to regulatory guidelines and standards, and the data generated by these methods must be robust, accurate, and reliable.

The main goal of pharmaceutical analytical development is to ensure that pharmaceutical products are of high quality, safe, and effective. This involves developing and validating analytical methods that can accurately and reliably measure the properties of the pharmaceutical compound or product. These methods are used throughout the drug development process, from early-stage development through commercialization and post-market surveillance.

Our scientists are experts in method development, validation, and execution.

CMC Pharma’s analytical chemists have decades of experience testing hundreds of pharmaceutical drug products and provide clients with excellent analytical chemistry expertise. 

This includes the development of analytical methods by U/HPLC/ LC-MS and other techniques as well as the development and validation of potency and related substances with stability-indicating methods. The experienced team at CMC Pharma regularly test APIs, drug products, excipients, and reference standards while executing a wide variety of analytical methods. These include Karl Fisher, osmolarity, dissolution, in vitro release testing, and others. Our scientist are also highly experienced with a large number of USP tests.

cmc scientist analysist
CMC Pharma is well equipped with standard laboratory fixtures, safety equipment, and a wide variety of specialized equipment and instrumentation for the analysis of pharmaceutical drug products.

Equipment Includes:

  • UHPLC
  • ICH Stability Chambers
  • UV/Vis Spectrophotometer
  • Karl Fisher Titrator
  • Osmometer
  • Analytical Balances
  • Dissolution Apparatus
  • Glove Boxes
  • Balance Enclosures
  • Tap Densitometer
  • Flowability Meter
  • Dissolution Apparatus
  • And More

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