Welcome to PURITAN

CUSTOM SYNTHESIS SERVICES:

Our extensive Custom Synthesis capabilities allow us to develop the products that our customers need, in a timely manner and at a reasonable price. Our Process Research team has the expertise to do multi-step syntheses to make standards or Impurities. we can produce high quality organic compounds synthesized on scales from milligrams to kilograms.

Our Quality Control ensures that isotopic enrichment and chemical purity of our products meet the required standards

IMPURITY ISOLATION AND CHARACTERIZATION SERVICES

Regulatory agencies have increased its focus on impurities profile of API, as some of this impurity may exhibit pharmacological activity and other toxic effects. Impurities impact not only the safety of drugs, but also the development time if not addressed early during the scale-up process We develop a suitable method or adapts an existing method for impurity isolation and characterization. Isolation of the impurities can be executed with preparatory HPLC using various detectors such as UV/PDA/RID or followed by detailed structure elucidation using MS and NMR techniques.

Impurity Characterization Techniques

Isolation:
  • Liquid/liquid or solid phase extractions
  • Preparatory TLC
  • Preparatory HPLC
  • Flash Chromatography
  • Semi-preparatory Liquid Chromatography

Purification:

  • Preparatory Chromatography
  • Recrystallization
  • Solid Phase Extraction (SPE)
  • Semi-preparatory HPLC

Structural Elucidation:

  • NMR (1H and 13C)
  • FTIR
  • MS and MS/MS
  • Elemental Analysis (CHNSO)
  • High Resolution LC/MS/MS
  • High Resolution GC/MS

Purity Characterization:

  • Assay (UV, HPLC, GC, CE, and IC)
  • Chromatographic Purity (TLC, CE, GPC/SEC, HPLC, and GLC)
  • Metallurgical Catalysts (ICP, ICP-MS, AA, AE)
  • Inorganic Ash (ROI, ICP, ICP-MS, AA)
  • Residual Solvents (Headspace GC)
  • Moisture (KF, CKF)

The results from impurity characterization studies can be presented as a formal report suitable for regulatory submissions