Regis' quality control (QC) department evaluates product integrity while allowing instant troubleshooting for our production staff. We run three shifts of QC chemists to support the three shift production schedule. This guarantees quicker turnaround and better allocation of resources for your API release, reference standard qualification, structure elucidation, and more.

INSTRUMENTATION

QUALITY CONTROL LABORATORY

The analytical laboratory is equipped with instrumentation to perform a variety of analytical tests including:

HPLC

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

  • Seven Agilent 1200 HPLC systems, Fourteen Agilent 1260 HPLC systems, and One Agilent 1100 HPLC systems containing:
    • Quaternary gradient pumps,
    • Vacuum degassers,
    • Autosamplers (ambient and cooled),
    • Column temperature controllers,
    • UV/VIS, DAD, RI and MS detectors,
  • Five Agilent 1290 HPLC/UHPLC systems and one Waters (I-Class) UPLC System
  • Dionex ICS-3000 Ion Chromatography system
  • Auxiliary Equipment, such as an Alltech ELSD 3300 and Agilent 1260 RID
  • Software: Dionex Chromeleon which meets 21 CFR Part 11 requirements

 

Regis Technologies scientist inserts chiral column into HPLC

GC

GAS CHROMATOGRAPHY

Regis Technologies scientists monitor analytical equipment during QC
  • Gas Chromatographs: Two Agilent 6890s, five Agilent 7890s (three 7890A and two 7890B), and one Thermo Trace 1310 
  • Injectors: Split/splitless and cool-on-column
  • Detectors: FID and MS
  • Autosamplers: Agilent 7683/7683B, Agilent G1888 headspace, Agilent 7693/7693A, Agilent 7697A, and Thermo TriPlus RSH Headspace
  • Software: Dionex Chromeleon Version 7.2 Integration and security system which meets 21 CFR Part 11 requirements

QC INSTRUMENTATION

OTHER TYPES OF ANALYSIS & ASSAYS

Nuclear Magnetic Resonance (NMR) Spectroscopy

  • Bruker Ultrashield 400MHz
  • Probes: 1H, 13C, 15N 19F, 31P
  • GMP Qualified
ICP-MS 
  • Thermo Scientific iCAP TQ, with PrepFast sample introduction system, and a CEM MARS 6 microwave digestion apparatus

Mass Spectrometry

  • High resolution MS system Waters UPLC/Xevo G2-XS QTof
  • QTRAP MS system ABSciex 3200

Particle Size Analysis

  • Two Malvern Mastersizer 3000 Particle Size Analyzers with both wet and dry dispersion capability
Discovery TGA (Thermogravimetric Analyzer)
  • TA Discovery TGA with TRIOS Software and equipped with autosampler

X-Ray Powder Diffraction (XRPD)

  • Bruker D8 Advance equipped with a 54-position AUTO-CHANGER and a LYNXEYE super speed detector (variable temperature capable)
Dynamic Vapor Sorption (DVS) 
  • TA Instruments Q5000SA gravimetric water sorption analyzer

UV/VIS

  • Two Hitachi U-2910 with UV Solutions Software

 FTIR

  • Two Perkin Elmer with Spectrum software

Balances

  • Mettler AT201 Analytical Balance
  • Mettler MX5 Micro Balance
  • XP205 Analytical Balance
  • AX205 Analytical Balance

DSC

  • Two Mettler Star Systems (DSC1 and DSC3)

Other Assays

  • Viscosity
  • Volumetric Karl Fischer with jacketed vessel
  • Coulometric Karl Fischer with oven
  • Melting Point
  • LOD
  • ROI
  • Optical Rotation - polarimeter
  • Other miscellaneous USP and wet chemistry tests

 

Nuclear Magnetic Resonance (NMR) Spectroscopy

HAVE A CHEMISTRY NEED? REQUEST A QUOTE.