Services

GMP Chromatography & Chemistry

Averica Discovery Services, Inc.

Our skilled and competent GMP chemistry group uses a wide range of methods to test raw materials, finished products and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

Over the years, the GMP team at Neopharm Labs has successfully developed/validated/transferred in excess of 3,000 HPLC, GC or other chemistry analytical procedures.


Analytical Services Provided

  • UPLC, HPLC, GC and IC analyses
  • Process and cleaning validations
  • Container/packaging testing
  • Physical and wet chemical analysis
  • Residual solvents
  • Stability storage and testing
  • Method development and validation
  • API Characterization
  • Total organic carbon (TOC)
  • Dissolution studies
  • Spectroscopy
  • Vitamin assays
  • Antibiotic assays
  • Enzymatic testing
  • Protein/Nitrogen analysis
  • Gel strength
  • Identification of impurities with LC-MS (Q-TOF) and GC-MS


Samples Analyzed

We perform analysis on many types of samples including but not limited to:

  • Pharmaceutical, veterinary, cosmetics, antibiotics, enzymes, medical marijuana and natural health products
  • Finished products: oral solid dosage forms (i.e tablets, capsules), liquids (i.e injectable, oral, topical, drops, syrup), semisolid dosage forms (i.e creams, gels, lotions, shampoos), pads, swabs and suppositories
  • Raw materials: active pharmaceutical ingredients, fillers, binders, lubricants, colors and other excipients
  • Container/packaging components: plastics, glass, foils, bottles, strip packs and cards
  • In-process products: bulk mixtures of solids or liquids prior to filling into capsules, bottles, vials and syringes, or before compressing into tablets
  • Utility systems: HVAC, water-for-injection (WFI), purified water, clean/pure steam, compressed air systems, nitrogen,etc.


Instrumentation

  • UPLC – UV/visible and diode-array
  • HPLC – UV/visible, diode-array, fluorometric, electrochemical, conductivity, refractive index and ELSD detection
  • GC – Flame ionization, and thermal conductivity detection, on-column and headspace techniques for packed and capillary columns
  • Dissolution – USP or Ph Eur methods I, II, III
  • GC-MS
  • Spectroscopy – infrared and UV
  • AAS – atomic absorption spectrophotometer, FIAS and graphite furnace/flame
  • ICP-MS
  • Viscosity/Rheometry
  • Particle Size Analyzer
  • Differential Scanning Calorimetry (DSC)

Click for more information about how we use our technology systems.