Quality Control

Regis' Quality Control (QC) department evaluates product integrity while allowing 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 (7) Agilent 1200 HPLC systems, Fourteen (14) Agilent 1260 HPLC systems, and One (1) Agilent 1100 HPLC system containing:
    • Quaternary gradient pumps
    • Vacuum degassers
    • Autosamplers (ambient and cooled)
    • Column temperature controllers
    • UV/VIS, DAD, RI, and MS detectors
  • Five (5) Agilent 1290 HPLC systems and 1 Waters (I-class) UHPLC system
  • One (1) Dionex ICS-6000 Ion Chromatography system
  • Additional detectors: Two (2) Alltech ELSD 3300, One (1) Agilent 1260 G1362A RID, and Two (2) Corona Veo RS CAD
  • Software: Dionex Chromeleon which meets 21 CFR Part 11 requirements
GC

Gas Chromatography

  • Gas Chromatographs: Two (2) Agilent 6890s (6890N), five (5) 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

Mass Spectrometry

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

ICP-MS

  • Thermo Scientific iCAP TQ, with PrepFast sample introduction system, and a CEM MARS 6 microwave digestion apparatus

Particle Size Analysis

  • Two (2) Malvern Mastersizer 3000 Particle Size Analyzers with both wet and dry dispersion capability

X-Ray Powder Diffraction (XRPD)

  • Bruker D8 Advance equipped with a 54-position AUTO-CHANGER and a LYNXEYE super speed detector (variable temperature capable)

Thermogravimetric Analyzer (TGA)

  • TA Discovery TGA with TRIOS Software and equipped with autosampler

DSC

  • Two (2) Mettler DSCI Star Systems
  • TA Instruments DSC 2500 equipped with an auto-sampler and RCS90 (modulation DSC capable)

Dynamic Vapor Sorption (DVS)

  • TA Instruments Q5000SA gravimetric water sorption analyzer

Polarized Light Microscope (PLM)

  • Nikon Eclipse LV100N POL polarized light microscope

Thermal Microscopy

  • Linkam LTS420

UV/VIS

  • Two (2) Hitachi U-2910 with UV Solutions Software

FTIR

  • Two (2) Perkin Elmer (one Spectrum 100 and one Spectrum Two) with Spectrum software

Balances

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

Other Assays

  • Viscosity
  • Volumetric Karl Fischer with jacketed vessel
  • Coulometric Karl Fischer with oven
  • LOD
  • ROI
  • Optical Rotation Polameter
  • Autotitrator
  • Other miscellaneous USP and wet chemistry tests

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 (7) Agilent 1200 HPLC systems, Fourteen (14) Agilent 1260 HPLC systems, and One (1) Agilent 1100 HPLC system containing:
    • Quaternary gradient pumps
    • Vacuum degassers
    • Autosamplers (ambient and cooled)
    • Column temperature controllers
    • UV/VIS, MWD, DAD, VWD, RI, and MS detectors
  • Five (5) Agilent 1290 HPLC systems and 1 Waters (I-class) UHPLC system
  • One (1) Dionex ICS-6000 Ion Chromatography system
  • Additional detectors: Two (2) Alltech ELSD 3300, One (1) Agilent 1260 G1362A RID, and Two (2) Corona Veo RS CAD
  • Software: Dionex Chromeleon which meets 21 CFR Part 11 requirements
GC

Gas Chromatography

  • Gas Chromatographs: Two (2) Agilent 6890s (6890N), five (5) 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 7.1 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

Mass Spectrometry

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

ICP-MS

  • Thermo Scientific iCAP TQ, with PrepFast sample introduction system, and a CEM MARS 6 microwave digestion apparatus

Particle Size Analysis

  • Two (2) Malvern Mastersizer 3000 Particle Size Analyzers with both wet and dry dispersion capability

X-Ray Powder Diffraction (XRPD)

  • Bruker D8 Advance equipped with a 54-position AUTO-CHANGER and a LYNXEYE super speed detector (variable temperature capable)

Thermogravimetric Analyzer (TGA)

  • TA Discovery TGA with TRIOS Software and equipped with autosampler

DSC

  • Two (2) Mettler DSCI Star Systems
  • TA Instruments DSC 2500 equipped with an auto-sampler and RCS90 (modulation DSC capable)

Dynamic Vapor Sorption (DVS)

  • TA Instruments Q5000SA gravimetric water sorption analyzer

Polarized Light Microscope (PLM)

  • Nikon Eclipse LV100N POL polarized light microscope

Thermal Microscopy

  • Linkam LTS420

UV/VIS

  • Two (2) Hitachi U-2910 with UV Solutions Software

FTIR

  • Two (2) Perkin Elmer (one Spectrum 100 and one Spectrum Two) with Spectrum software

Balances

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

Other Assays

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

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