Services – Analytical Research

Analytical Research

Dedicated analytical laboratories for fast track developmental work and GMP laboratory with successful track record, having proven systems for regulatory submission activities and to handle commercial sample for release, validation as well as stability studies. Successfully Inspected twice by USFDA, in 2013 and 2017. Solution for all Analytical activities - From project initiation to tech transfer and support for product filing as per regulatory requirements. Work done here has resulted into many approved ANDAs for customer. E.g. Venlafaxine HCl, Acetazolamide, Dapsone, etc.

Expertise
  • Expertise in In-Vitro Comparative Nasogastric (NG) and Gastronomy Tube studies as per USFDA submission requirements.
  • Method development and method validation,
  • Multimedia dissolution,
  • Force degradation studies,
  • Particle size analysis,
  • Crystallinity and film coating thickness measurement on high resolution optical microscope.
  • Reverse engineering studies for Innovator characterization using various techniques as per customer requirement etc.
  • Characterizations of molecule using HPLC, UV, FTIR and ICP OES.
  • Stability studies for Pivotal as well commercial batches of US market and other regulated market
Facility
  • HPLCs (including RRLCs) with multiple - VWD, PDA, RID, FLD
  • GC with HSA
  • ICP-OES with VGA attachment enabling enhancement in elemental quantification
  • High resolution stereo zoom optical trinocular microscope with polarised light attachment with digital image capturing in CFR compliant software.
  • Dissolution machines to handle low solubility substances, light sensitive substances.
  • Photo stability chamber.
Stability Studies

Enem Nostrum stability Services is able to design, execute and analyze pre-stability / regulatory or commercial stability studies, according to the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) conditions:

  • ICH Stability cabinets to evaluate product stability based on real-time, accelerated and long-term by controlling temperature and relative humidity. 25°C & 60%RH, 30°C & 65%RH, 40°C & 75%RH, 30°C & 75%RH

Photo Gallery