Chromatography & Chemistry

Chromatography & Chemistry

Our skilled and competent 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, Neopharm has successfully developed/validated/transferred in excess of 3,000 HPLC, GC or other chemistry analytical procedures.

ANALYTICAL SERVICES PROVIDED

Our analysts can assist you with numerous routine and specialized techniques and provide support for regulatory submissions (i.e NDA, IND, CTA):

  • 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 impurties with LC-MS (Q-TOF) and GC-MS

SAMPLES ANALYZED

We perform analyses 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)