Regis' quality control (QC) department evaluates product integrity while allowing instant troubleshooting for our production staff. We run two shifts of QC chemists to support the two shift production schedule. This guarantees quicker turnaround and better allocation of resources.

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, Six Agilent 1260 HPLC systems, and Six Agilent 1100 HPLC systems containing:
    • Quaternary gradient pumps,
    • Vacuum degassers,
    • Autosamplers (ambient and cooled),
    • Column temperature controllers,
    • UV/VIS, MWD, PDAD, VWD, RI and LC/MS detectors,
  • Three Agilent 1290 HPLC/UHPLC systems
  • 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

 

HPLC in our Quality Control Lab

GC

GAS LIQUID CHROMATOGRAPHY

GC in our Quality Control Lab
  • Two Agilent 6890s, Three Agilent 7890s, one Agilent 7890B GC, and One Thermo Trace 1310 Gas Chromatographys
  • Injectors: Split/splitless and cool-on-column
  • Detectors: FID and MS
  • Autosamplers: Agilent 7683, Agilent G1888 headspace, Agilent 7697A, Agilent 7697B Headspace 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

Particle Size Analysis

  • Malvern Mastersizer 2000/3000 Particle Size Analyzer

Discovery TGA (Thermogravimetric 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

  • Mettler DSCI Star System

Other Assays

  • Viscosity
  • Volumetric Karl Fischer
  • Coulometric Karl Fisher
  • Melting Point
  • LOD
  • ROI
  • Optical Rotation
  • Other miscellaneous USP and wet chemistry tests

 

Nuclear Magnetic Resonance (NMR) Spectroscopy

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