Analytical Method Development & Support

Analytical Methods & Analytical Chemistry Services - IRISYS

IRISYS has developed and validated analytical methods for hundreds of products. Such methods enable the quantification of drug level in novel formulations. Analytical methods are also a requirement for drug product release in GMP clinical and commercial manufacturing.

Analytical methods: transfer & qualification

The analytical chemistry services at IRISYS provide full analytical support for our clients. We develop, validate, qualify and transfer analytical techniques and methods that are used to quantify drug substance purity and the percentage of drug content in a dosage form.

Full analytical method development & validation

We design and conduct studies to determine the physical and chemical characteristics of the compound of interest, including small organic molecules, peptides and proteins.

Microbiology testing

IRISYS conducts the testing needed to ensure the sterility and stability of finished drug products.

IRISYS provides the following analytical chemistry services:

  • Reference standard characterization
  • Analytical methods development
  • Stability-indicating method development
  • Impurity profile generation
  • Degradation product identification
  • Analytical methods qualification
  • Analytical methods validation

IRISYS provides the following preformulation development studies:

  • Dissolution testing according to USP
  • Dosage unit analysis for potency, purity and content uniformity
  • Excipient testing
  • Physical accelerated stress testing
  • Chemical accelerated stress testing
  • Specification development
  • Chromatographic system development
  • Identification of conditions required for optimal stability
  • Container/closure testing and selection
  • Pka and pI
  • Partition coefficient and distribution coefficient as a function of pH
  • pH-solubility profile
  • Intrinsic solubility
  • pH-stability profile at accelerated temperatures
  • Accelerated stability studies
  • Dissociation constants
  • Hygroscopicity analysis
  • Lipophilicity analysis
  • Moisture analysis
  • Excipient compatibility studies
  • Salt formation characteristics determination
  • Accelerated stability studies
  • Viscosity analysis
  • Disintegration studies
  • Dissolution studies

What is analytical support at IRISYS?

Visit our Case Studies to see how IRISYS has helped clients with:

  • Analytical method development
  • Use of analytical techniques in pharmaceutical analysis

For more information about our Analytical Support services, fill out the contact form below: