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PharmaGMP Testing – GBA Pharma LabsInstrumentation

Instrumentation

Device List and Analysis Methods

If the analysis that you need cannot be found on the list of analytical techniques, then the device list should give an indication of the methods we have established in our labs. For the equipment listed below, we generally have multiple devices available at several locations which ensures that your order will be processed on time. If the device that you are looking for is not on this list, then please contact our marketing department and we will gladly provide you with assistance.

Amino Acid Analyzer:

  • Amino Acid Analyzer for Ninhydrin-Positive Substances

Bio-Inert LC Systems:

  • Bio LC-ECD
  • Bio LC Conductivity Sensor

Biological Methods:

  • ELISA
  • Gel Electrophoresis
  • Western Blot

Chemical-Physical and Pharmaceutical Tests:

  • Abrasion Resistance
  • Refractive Index
  • Hardness
  • Density
  • Moisture Determination Using a Glove Box
  • Freezing Point
  • Freeze-Drying (Speed Vac)
  • Gravimetry (Loss on Drying, Total Ash, Residue on Ignition, Sulfated Ash)
  • Gradation Testing (Sieve Analysis)
  • Halogen Drying
  • Conductivity
  • Microscopy
  • Wet Chemistry (Ph.Eur, BP, USP, JP)
  • Osmotic Concentration
  • Subvisible particles via Particle Counting according Ph.Eur. 2.2.19
  • Particle Determination (Visible Particles, according to Ph.Eur. 2.9.20)
  • Particle Size distribution via Laser Light diffraction according Ph.Eur. 2.2.20
  • Polarimetry
  • Oxygen Determination
  • Melting Point
  • Bulk Density and Tapped Density (incl. Hausner Ratio)
  • Flash Point
  • Nitrogen Determination according to Kjeldahl
  • Tablet Hardness Testing
  • Titration, Automatic Titrators (e.g. Potentiometric)
  • Turbidity Measurements
  • Viscosity Testing (Torque Measurement, Cone/Plate)
  • Determination of Moisture Content according to Karl-Fischer – Coulometric Ph.Eur.2.5.32
  • Determination of Moisture Content according to Karl-Fischer – Titration Ph.Eur.2.5.12
  • Determination of Moisture Content according to Karl-Fischer – Stromboli Oven
  • Disintegration Testing (Suppositories, Pills)

Elemental Analyses:

  • AAS (Flame, Graphite Furnace, Hybrid – Batch and FIA Techniques)
  • ICP-MS
  • ICP-OES

Active Ingredient Dissolution:

  • Dissolution Testing using flow-through cells according to USP-IV for Active Ingredients with Low Solubility, Granules, Suppositories, Soft Gelatin Capsules
  • Dissolution Testing according to USP-I & USP-II; Offline and Online UV Detection

GC Systems:

  • Headspace-GC-FID
  • Headspace-GC-MS
  • GC-ECD
  • GC-FID
  • GC-MS
  • GC-PND
  • GC-WLD
  • GC-PTV Injection System
  • GC-Split/Splitless

HPTLC/TLC:

  • HPTLC/TLC Qualitative Analysis with Photo Documentation (UV, VIS, Fluorescence)
  • HPTLC Quantitative

LC Systems:

  • HPLC-CAD
  • HPLC-DAD
  • HPLC-ECD
  • HPLC-ELSD
  • HPLC-Fluorescence
  • HPLC-Conductivity Detector
  • HPLC-MS
  • HPLC-MS-QTOF
  • HPLC-PAD
  • HPLC-RI
  • HPLC-UV/VIS
  • HPLC-Post-Column Derivatization
  • GPC
  • GPC-RI (Molar Mass Distribution)
  • Ion Chromatography (Anions, Cations, Ion Suppression)
  • UPLC-DAD
  • UPLC-MS
  • UPLC-UV
  • Capillary Electrophoresis

Mass Spectrometry:

  • GC-MS
  • HPLC-MS
  • HPLC-MS-QTOF
  • UPLC-MS

Spectrophotometry:

  • FT-IR (ATR)
  • UV/VIS Spectrophotometer

Stability Studies:

  • Temperature-Controlled Stability Rooms and Chambers (all ICH Conditions; Special Conditions from -80°C to +55°C)
  • Photostability Tests: Atlas Suntester, WUT Stability Chamber (ICH Q1B)

The experienced and highly committed GBA Pharma Labs team offers a variety of different services in the following Areas.

GBA Pharma Labs – GMP Testing

More

GMP Quality Control

Method Development & Validation

Stability Studies

Dissolution

Extractables & Leachables

Packaging Material Testing

Particle Determination

Elemental Impurities Testing

Microbiology

Regulatory Services

Amino Acid Analysis

Instrumentation

GBA Pharma Labs Trace-level analytic for N-nitrosamines

N-nitrosamines

GBA Pharma Labs qPCR

qPCR

GBA Pharma Labs iCEF

cIEF

GBA Pharma Labs Protein characterization

Protein Characterization

GMP Testing

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