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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
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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
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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)
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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
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