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>>GMP Analytical Chemistry Testing
GMP Analytical Chemistry Testing2019-01-09T16:35:52-05:00

Nucro-Technics offers a broad range of services that cover both modern and classical analytical chemistry techniques to fulfill regulatory testing requirements for the Pharmaceutical, Biologic, Medical Device, and other related industries.  Being a contract laboratory, we are not limited to having expertise in a specific product class or for a particular therapeutic indication.

Analytical Chemistry studies conducted at Nucro-Technics are compliant with Good Manufacturing Practices (GMP) regulations as defined by the FDA, Health Canada, and the European Medicines Association.  These GMP chemistry studies are used to support the release of finished drug product to the market or to justify the use of a lot of raw material in a product formulation.  Where needed, method development, method validation, method transfer, and method verification activities can be conducted to fulfill regulatory requirements.

Nucro-Technics’ chemistry group also supports GLP dose formulation and pharmacokinetic (PK) studies.  These dose formulation and PK studies are part of an Investigational New Drug (IND) submission and are used in order to support moving into clinical trials.

MOST COMMON SERVICE OFFERINGS FOR GMP & GLP-COMPLIANT ANALYTICAL CHEMISTRY TESTING

Service OfferingService Detail
HPLC & UPLC Assays
  • Using the Agilent OpenLAB Platform to control instrumentation and fulfill data integrity requirements
  • Available Detectors Include: Variable Wavelength (VWD) UV, Diode Array (DAD) UV/VIS, Fluorescence, and Refractive Index
  • Auto-Sampler Refrigeration Capability
GC (Gas Chromatography) Testing
  • Using the Agilent OpenLAB Platform to control instrumentation and fulfill data integrity requirements
  • Direct Injection and Headspace Analysis>
  • Organic Volatile Impurities Analysis
  • Residual Solvents per USP <467>, Class I, II, or III>
  • Available Detectors Include: Flame Ionization (FID) and Thermal Conductivity (TCD)
Ion Chromatography Testing
ID Testing
  • Wet Chemistry
  • Infrared (IR) Spectroscopy
  • Fourier-Transform Infrared (FTIR) Spectroscopy
  • TLC Identification and Impurities
Glass Testing
  • Type I, Type II, and Type III glass per USP <660>
Heparin Assays
  • Anti-factor IIa Potency Testing (Microplate Absorbance Reader)
Elemental Impurities / Elemental Analysis Testing
  • Conducted via ICP/MS per USP <232> and the ICH Q3D Guideline
  • Covers all elements listed in USP <232> Table 1, Table 2, and Table 3
Dissolution Studies
  • Analysis by HPLC, GC, UV or Titrimetry
Other Instrumental Capabilities Commonly Requested
  • Total Organic Carbon (TOC)
  • Atomic Absorption Spectroscopy (AAS)
  • Flurometry
  • pH Testing
  • Mercury Analysis
  • Loss on Drying
  • Melting Point
  • Karl Fischer Water
  • Titrations

Let’s Work Together
For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, get in touch.