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Brochure

Analytical Solutions at Aragen

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Overview

Aragen Life Sciences offers a comprehensive suite of analytical services tailored to support drug development across preclinical, clinical, and commercial stages. With flexible engagement models exhibit (FTE & FFS), a robust infrastructure, and strong regulatory compliance, we deliver insightful, reliable, quality and timely data to drive your programs forward.

Quality & Regulatory Compliance

  • USFDA, PMDA, and cGMP Compliance
  • Zero Form 483s in Last 2 USFDA Inspections (2019, 2025)
  • 21 CFR Part 11 Compliant Electronic Systems
  • Document Management System (DMS) & Learning Management System (LMS)
  • ISO 17025-Aligned Practices

Core Capabilities

  • Method Development & Validation (ICH-compliant)
  • Nitrosamine Risk Assessment & Analysis
  • Impurity Profiling
  • Extractables & Leachables
  • Medical Device Chemical Characterization
  • Microbiology Testing
  • IVRT & NG/G Tube Studies
  • Phosphate Binding & Sameness Studies
  • Dissolution Studies
  • Microbial Kill Rate & Zone Inhibition Studies
  • Reference Standards Management & Life Cycle Management of Analytical Procedures, USP 1220

Stability Services

  • All ICH Conditions | 100,000 L Capacity | Photostability & Developmental Stability
  • Walk-in & Reach-in Chambers & Total Number of Chambers – 11
  • Stability-Indicating Method Development
  • Fully 21 CFR Part 11 Compliant Systems
TemperatureHumidityCapacity (Ltr)Type
25°C ± 2°C60% RH ± 5% RH2000Reach-in
16000Walk-in
30°C ± 2°C65% RH ± 5% RH2000Reach-in
75% RH ± 5% RH16000Walk-in
40°C ± 2°C75% RH ± 5% RH16000Walk-in
20% RH ± 5% RH2000Reach-in
40°C ± 2°C20% RH ± 5% RH600Reach-in
25°C ± 2°C40% RH ± 5% RH600Reach-in (2)
5°C ± 3°CNA2000Reach-in
Photo Stability Chamber100Reach-in

Instrumentation Highlights

CategoryDetails
Solid State CharacterizationPXRD, TGA, PSA, DSC
HPLC18 HPLC & 02 UPLC (Agilent Technologies, Model: 1260 Infinity Series. Waters (Alliance), Model: e2695 Separation Module & 2489 UV/Vis., Arc HPLC.) with Empower 3
GC, GC-HS, GC-MS, GC-MS/MSAgilent Technologies, Model: GC-7890B; HS-7697A; MSD-5977D. Agilent Technologies, Model: GC-7890B; HS-7697A; MSD-7010B GC/TQ, ALS-7693. ECM Server
Dissolution StudiesElectrolab, Model: EDT-14LX (14 Bowls), EDT-8LX (08 bowls), No of Apparatus: 06
LC-MS/MSAB Sciex, Model: API 4000, LC Agilent.
Waters, Model: Xevo-TQ-XS, Xevo-TQ-Absolute, Xevo-Micro
HRMS (Development Lab)QTOF, Orbitrap, Q Extractive
HRMS (GMP)Orbitrap
ICP-MSAgilent Technologies, Model: 7800 with ECM Server
ICThermo, Model: ICS-5000 Plus; Chromeleon Software