Analytical Development and Testing Services

We offer a wide array of capabilities to meet your needs:

  • Method Development
  • Method Validation
  • Method Verification
  • Monograph Remediation
  • Method Transfer

From the laboratory to project management, our well seasoned experience supports all major characterization and compendial tests:

  • Active drug substance and finished product assay
  • Impurities and degradation products determination
  • Drug release and dissolution behavior
  • Extractables / leachables
  • USP Residual Solvent testing

Preformulation Development & Testing

With over 20 years experience in physical-chemical pharmaceutics and active / inactive raw materials characterizaton, Aztech Sciences Inc. can provide a comprehensive physical and chemical platform for the development of your compounds of interest, whether it be a new chemical entity or an existing compendial substance:

  • Acid / base equilibria: pKa / pKb determination
  • Salt and solid state polymorphic and amorphous solid state screening
  • Solubility and solubilization evaluation
  • Active / inactive ingredients compatibility assessment
  • Container / closure systems evaluation
  • Bulk powder flow properties
  • Phase behavior evaluation for semi-solid emulsions, microemulsions and suspensions
  • Solution chemistry of dosage forms for parenteral applications

Formulation & Product Development

Whether your organization is a start-up or fitted as a large company, Aztech Sciences Inc. staff has the expertise and industry experience to develop  various formulation and product platforms to support your portfolio regardless of life-cycle stage whether it be preclinical or post-commercial endeavors

  • Solid dosage forms (oral tablets, capsules, reconstitution powders, amorphous and other specialized forms)
  • Semi-solid forms (gels, ointments, creams, lotions, suspensions)
  • Liquid dosage forms (solutions, cosolvent systems for parenteral, IM and other delivery systems)

Analytical Capabilities

Aztech Sciences Inc. services are accomplished under strict quality standards and sound scientific principles using the following core technologies:

  • Chromatography: HPLC, UPLC, GC, LC-MS
  • Spectroscopy: UV-Vis PDA, FTIR
  • Potentiometry: Acid/Base Titration, Karl Fischer Water Determination
  • Dissolution and Drug Release Testing: USP I & II Apparatus, Franz Cell Membrane In-Vitro Release Testing
  • Thermal Analysis & Rheology: MDSC/TGA/Rheometry
  • Optical Polarized Microscopy
  • X-Ray Powder Diffractometry (XRPD)

The organizational scientific methods and project management philosophy are guided by the most current FDA/EU and ICH (International Conference on Harmonization) guidelines in adherence to cGLP/cGMP statues governing the pharmaceutical industry while complemented using a quality risk management (QRM) and quality-by-design approach to all of its core work.

Formulation Development Technologies

Our technology platform provides a comprehensive array of formulation capabilities whatever your product endeavors may be: from preclinical, phases I - III, to post-commercial life cycle management product extensions:

  • Granulation of active & inactive raw material powders to meet your densification requirements
  • Tablet compression & compaction mechanics evaluation
  • Ingredient compatibility evaluation using suitable stability-indicating methods of analysis
  • Solution and solvent miscibility behavior evaluation for parenteral and oral liquid dosage forms
  • Emulsification, miscibility and polymer evaluation for topical dosage form development
  • Particle phenomena assessment supporting suspension dosage form evaluation
  • High-energy amorphous solids & dispersions
  • Specialized & complex product development