Analytical Development

Analytical Development services are crucial to the quality, safety, and regulatory compliance of pharmaceutical products. At Aizant, our cutting-edge laboratories support the entire drug development lifecycle, from early development through commercialization, with precise and reliable analytical testing.

Analytical Development Services

Physical and Chemical
Testing

Aizant utilizes robust, reliable, and reproducible analytical methods for critical testing, including HPLC, GC, and LC-MS.

Stability Studies

Our stability testing services assess the shelf life of drug products under various conditions, confirming that products retain their potency and safety throughout their lifecycle.

Type-4 Dissolution

Aizant’s Type-4 dissolution testing ensures our products meet stringent release parameters, quality standards, and regulatory compliance throughout the manufacturing process.

Method development

Utilization of advanced techniques such as discriminating dissolution testing, particle size analysis, and residual solvent testing to verify that drug products meet the required quality standards.

Bioavailability & Bioequivalence Testing

We offer bioanalytical testing to support bioequivalence studies for generic drug approval, confirming that the drug is absorbed and metabolized similarly to the reference product.

Impurity Profiling

Subject Matter Experts from Aizant use techniques like HPLC, LC-MS, and GC-MS to identify and quantify impurities, confirming that all products meet purity and safety standards.

Key Analytical Equipment

  • High-Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • LC-MS/MS (Liquid Chromatography-Mass Spectrometry)
  • Fourier-Transform Infrared Spectroscopy (FTIR)
  • X-Ray Diffraction (XRD)
  • Dissolution Apparatus
  • Scanning Electron Microscopy (SEM)
  • Atomic Absorption Spectroscopy (AAS)
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

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