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Quality Control

Ensuring your product's integrity

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.

Quality Control Laboratory

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

High Performance Liquid Chromatography

  • Seven Agilent 1100 HPLC systems and three Agilent 1200 HPLC systems containing: Quaternary gradient pumps, vacuum degassers, autosamplers (ambient and cooled), column temperature controllers, UV/VIS, MWD, PDAD, VWD and LC/MS detectors, computer controlled ChemStation integration system and ChemStore security system which meets 21CFR part 11 requirements.

Auxiliary Equipment

  • Alltech ELSD 2000

Gas Liquid Chromatography

Three Agilent 6890 Gas Chromatographs

Injectors: Split/splitless and cool-on-column
Detectors: FID, TCD, MS
Autosamplers: Agilent 7683 and Agilent 7694 headspace
Software: ChemStation integration system and Chemstore security system which meets 21CFR Part 11 requirements

Particle Size Analysis

  • Malvern Mastersizer 2000 Particle Size analyzer which meets 21CFR Part 11 requirements

Elemental Analysis

Perkin Elmer 2400 Series II for carbon, hydrogen, nitrogen and sulfur

UV/VIS: Hitachi U-2810 with UV solutions software.
FTIR: Perkin Elmer Spectrum One with Assure ID.
Balances: Mettler AT201 Analytical balance, Mettler MX5 Micro balance, XP205 Analytical balance, AX205 Analytical balance
DSC: Mettler DSCI Star System

Other AssaysOther Assays

  • Viscosity, volumetric Karl Fischer, coulometric Karl Fisher, melting point, LOD, ROI, optical rotation and other miscellaneous USP and wet chemistry tests.