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 a variety of instrumentation to perform a range of analytical tests.
HPLC
High Performance Liquid Chromatography
- Four Agilent 1200 HPLCs, eighteen Agilent 1260 HPLCs, and six Agilent 1290 UPLCs .
- HPLC systems contain:
- Quaternary gradient pumps
- Vacuum degassers
- Autosamplers (ambient and cooled)
- Column temperature controllers
- UV/VIS, DAD, and MS detectors
- One Waters I-class system
- Two Alltech 3300 ELSDs, and Two Corona Veo RS CAD
- Software: Dionex Chromeleon 7.2 (meets 21 CFR Part 11 requirements)
GC
Gas Chromatography
- Gas Chromatographs: two Agilent 8890s, two Agilent 6890s (6890N), and five Agilent 7890s (three 7890A and two 7890B)
- Injectors: Split/splitless and cool-on-column
- Detectors: FID and MS
- Autosamplers: Agilent 7683/7693A, Agilent G2614A, and TriPlus RSH
- Headspace: Agilent G1888, and Agilent 7697A
- Software: Dionex Chromeleon Version 7.2 (meets 21 CFR Part 11 requirements)
IC
Ion Chromatography
- One Dionex ICS-6000 Ion Chromatography System
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 (non GMP only-used for reference)
- 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 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)
UV/VIS
- Two Hitachi U-2910 Spectrophotometers
FT-IR
- Two Perkin Elmer FT-IRs (one Spectrum 100 and one Spectrum Two)
Balances
- Mettler Toledo XP205 Analytical Balance
- Mettler Toledo XPE205 Analytical Balance
- Mettler Toledo XPR205 Analytical Balance
- Mettler Toledo MX5 Micro Balance
- Mettler Toledo MX10 Micro Balance
Other Assays
- One Mettler Toledo Autotitrator T5
- Two Metrohm Coulometric Karl Fischer with oven
- Two Metrohm Volumetric Karl Fischer with jacketed vessel
- One Color Light Box (appearance)
- Two Mettler Toledo DSCs
- Two Mettler Toledo Halogen Analyzers (LOD)
- One Rudolph Autopol V Plus Autopolarimeter (Optical Rotation)
- One TA Discovery TGA
- One Suntest CPS + Photostability Chamber
- Two Brookfield Viscosity
Instrumentation
Quality Control Laboratory
The analytical laboratory is equipped with a variety of instrumentation to perform a range of analytical tests.
HPLC
High Performance Liquid Chromatography
- Four Agilent 1200 HPLCs, eighteen Agilent 1260 HPLCs, and six Agilent 1290 UPLCs .
- HPLC systems contain:
- Quaternary gradient pumps
- Vacuum degassers
- Autosamplers (ambient and cooled)
- Column temperature controllers
- UV/VIS, DAD, and MS detectors
- One Waters I-class system
- Two Alltech 3300 ELSDs, and Two Corona Veo RS CAD
- Software: Dionex Chromeleon 7.2 (meets 21 CFR Part 11 requirements)
GC
Gas Chromatography
- Gas Chromatographs: two Agilent 8890s, two Agilent 6890s (6890N), and five Agilent 7890s (three 7890A and two 7890B)
- Injectors: Split/splitless and cool-on-column
- Detectors: FID and MS
- Autosamplers: Agilent 7683/7693A, Agilent G2614A, and TriPlus RSH
- Headspace: Agilent G1888, and Agilent 7697A
- Software: Dionex Chromeleon Version 7.2 (meets 21 CFR Part 11 requirments)
IC
Ion Chromatography
- One Dionex ICS-6000 Ion Chromatography System
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 (non GMP only-used for reference)
- 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 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)
UV/VIS
- Two Hitachi U-2910 Spectrophotometers
FT-IR
- Two Perkin Elmer FT-IRs (one Spectrum 100 and one Spectrum Two)
Balances
- Mettler Toledo XP205 Analytical Balance
- Mettler Toledo XPE205 Analytical Balance
- Mettler Toledo XPR205 Analytical Balance
- Mettler Toledo MX5 Micro Balance
- Mettler Toledo MX10 Micro Balance
Other Assays
- One Mettler Toledo Autotitrator T5
- Two Metrohm Coulometric Karl Fischer with oven
- Two Metrohm Volumetric Karl Fischer with jacketed vessel
- One Color Light Box (appearance)
- Two Mettler Toledo DSCs
- Two Mettler Toledo Halogen Analyzers (LOD)
- One Rudolph Autopol V Plus Autopolarimeter (Optical Rotation)
- One TA Discovery TGA
- One Suntest CPS + Photostability Chamber
- Two Brookfield Viscosity
Request for Information
Rely on our expertise to accelerate your project from preclinical to commercialization, fast. Connect with our team and learn how we can help expedite your project to the next phase.