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Brochure

Analytical Solutions Laboratory

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Aragen with a team of experts converge to oer a diverse range of analytical capabilities. With our flexible service models, including Full-Time
Equivalent (FTE) and Fee-for-Service (FFS), we tailor our support to your specific needs. Whether you require dedicated research partners through
FTE or on-demand access to our advanced instrumentation and expertise through FFS, ASL is your gateway to precise and insightful analytical
solutions, driving progress and innovation in your projects.

cGMP Analytical Solutions Overview

Experts in Advanced Studies
  • Extractable for pharmaceutical packaging, container
    losure & manufacturing component. EPDM packaging,
    HDPE, PP, LDPE container, tubing, Gasket & O Ring etc
  • Adhesive, ink migration study for labels & delamination
    study for glass
  • Leachable studies for injectable, ophthalmic, inhalation,
    vaccine, parenteral, topicals and dermal patches
  • Chemical characterization for medical devices
  • Nitrosamine assessment – by qualitative & quantitative
    technique
  • Life cycle management, complex product management,
    reference standards, USP 1220
  • Dissolution study – USP Type IV, III, II and I
  • NG/G tube studies, IVRT studies, in-vitro binding study /
    phosphate binding study & sameness study experience
    with sevelamer, colesevelam, cholestryramine
  • Microbial kill rate study & zone inhibition study
  • Physical characterization by XRD, DSC, TGA, IR
  • Polymorphic screening & quantification for OSD, injectable & topical product
  • Genotoxic impurity profiling & characterization
  • Method development & validation for small & large
    molecules
Regular Analytical Services
  • Method development and validation as per ICH guideline
  • Assay & related substance by chromatographic technique
  • Content uniformity and force degradation study
  • Microbiology (MLT, BET, AET, sterility and microbial assay)
  • Elemental impurity by ICPMS
  • Impurity profiling for organic, inorganic, and genotoxic impurity
  • Physical characterization, crystallinity, amorphous content
Infrastructure
  • UHPLC – MS/MS
  • HPLC – MS/MS
  • ICP-MS
  • GC-HS-MS/MS
  • GC-ALS-MS/MS
  • GC-HS-MS
  • GC-ALS-MS
  • GC-HS-FID
  • GC-ALS-FID
  • Dissolution
  • FT-IR
  • UV
  • PSD
  • pXRD
  • DSC
  • TGA
  • IC
  • TOC
  • Stability Chambers
  • Photo Stability Chambers
  • HPLC-UV
  • HPLC-PDA
  • HPLC-RI
  • DT
  • KF
  • Potentiometer
Expertise in Stability Studies
  • All ICH Stability Conditions
  • 100,000 L stability storage facility
  • Developmental Stability
  • Photostability Studies
  • cGMP registration stability programs
  • Development and validation of stability indicating methods including dissolution testing
  • Validated monitoring system, 21 CFR part 11 compliant
  • Walk-in and backup reach-in chambers
  • Comprehensive documentation
Quality Management System
  • Operates in full compliance with US-FDA and cGMP requirements.
  • Electronic Data Handling Compliant with FDA 21 CFR Part 11
  • DMS( Document Management System)
  • LMS( Learning Management System)
  • 200+ GMP Client-Initiated Audits Since 2017
  • Implementation of quality systems in accordance with cGMP, ISO 17025

Accreditations and Approvals