Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. Impurity levels need to be understood and  controlled for the benefit of safely  administering pharmaceutical products to humans. Impurities impact not only the safety of drugs, but also the development time if not addressed early during the scale-up process.

Learn about elemental impurities and the new ICH Q3D and USP <232> and <233> guidelines here.

Email Andy Miles with Pharmaceutical Services (amiles@registech.com) for more information on how we can help with your project.

UNKNOWN & TRACE IMPURITIES

IMPURITY ISOLATION

Supercritical Fluid Chromatography (SFC) for the Isolation of Unknown or Trace Impurities

Regis utilizes state of the art chromatographic techniques to isolate your unknown impurity or trace impurity in drug substances or drug products for structural elucidation. Tools such as Preparative HPLC, SFC, Automated Flash Chromatography, and preparative TLC are dedicated to isolation and purification of compounds and low level impurities.

GUIDE CMC ANALYSIS

IMPURITY CHARACTERIZATION

Regis Tech characterizes and potentially identifies impurities and degradation products present in your API or drug product. Information obtained can be used to help with toxicology studies and guide CMC analysis of API. Suitable analytical methods can be developed and validated for your existing impurities or degradation products. Our Analytical Method Development Group has the knowledge and tools to characterize your impurities using:

  • LC/MS or LC/MS/MS;
  • HPLC and UPLC;
  • GC/MS;
  • FTIR;
  • 1H, 13C, 15N, 19F, & 31P NMR enhanced with 2D NMR methods (COSY, HSQC and NMBC);
  • High Resolution Mass Spectrometry (HRMS) and elemental analysis.
High Resolution Mass Spectrometry (HRMS) and elemental analysis

MULTI-STEP SYNTHESES

SYNTHESIS SCALE-UP FOR REFERENCE STANDARDS

Regis can produce high quality organic compounds synthesized on scales from milligrams to kilograms.

Our Process Research team has the expertise to do multi-step syntheses to make reference standards. Regis can produce high quality organic compounds synthesized on scales from milligrams to kilograms.
 

CGMP REFERENCE STANDARD

QUALIFICATION

Regis can do qualification and issue a cGMP Certificate of Analysis (COA) on a synthesized impurity for a reference standard.
 

Qualify your synthesized impurity for a reference standard.

HAVE A CHEMISTRY NEED? REQUEST A QUOTE.