SWBOjsFWG5+QmtcUfkMMKtGDMSoLluX+WZISzkMNh8g= Analytical Development | ASolution Pharmaceuticals

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Sugammadex Sodium API Development niche manufacturer

ASolution offers a wide gamut of analytical support for drug discovery, pharmaceutical development and manufacturing requirements. Our experienced analysts combined with our CGMP compliant facility equipped with state-of-the-art instruments and regulatory compliant software provide us with rapid and accurate product characterisation and method development.

We perform stability testing under ICH and custom conditions for preclinical to commercial supply. ASolution adapts to your procedures or develops one for you. We perform Active Pharmaceutical, Formulation prototype, Pre-clinical and clinical, Temperature excursion, IND, NDA, ANDA and Commercial stability studies

CORE CAPABILITIES

  • Analytical Method Development & Validation

  • Method Transfer

  • Process Development, Optimization & Validation

  • Stability-indicating methods

  • Gas and liquid chromatography, including HPLC, UPLC, GC/MS and LC/MS/MS

  • UV-Vis and IR spectroscopy

  • Wet chemistry

ANALYTICAL EQUIPMENT

  • Spectrophotometers – UV/ Visible & FTIR

  • HPLCs – PDA, UV & IR

  • UPLCs

  • HUPLC with Carona Charged Detector

  • GCs with auto samplers

  • LCMS

  • KF Titrators

  • Polarimeter

  • Dissolution Testing System

  • Analytical Balances

  • Walk in & Reach in Chambers for Stability Testing

CHAMBER

25°C/60% RH

40°C /75% RH

30°C /65% RH

30°C /75% RH

2-8°C

Photostability

CAPACITY (L)

8000

1000

1000

1000

1000

227

STABILITY STORAGE

Development Services 

We have the capacities and the expertise to develop an API or Formulation right from early stages to manufacturing.