Impurity Services

Regulatory agencies focus on the control of impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can exhibit potentially deleterious effects, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. Impurity levels need to be well 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 timeline if not addressed early during the API scale up process.

Learn about elemental impurities, the new ICH Q3D and USP <232> and <233> guidelines, and our onsite ICP-MS testing here.

Unknown & Trace Impurities

Impurity Isolation

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

Guide CMC Analysis

Impurity Characterization

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

  • ICP-MS
  • LC/MS or LC/MS/MS
  • HPLC and UPLC
  • GC/MS
  • FTIR
  • 1H, 13C, 15N, 19F, & 31P 400 MHz NMR with cryogenic probe enhanced with 2D NMR methods (COSY, HMBC, HSQC, and DEPT 135)
  • High Resolution Mass Spectrometry (HRMS) and elemental analysis
  • Modeling Software (SpartanPro)

Multi-Step Syntheses

Synthesis of Reference Standards

Our Process Chemistry teams have 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 characterize, quality and issue a CGMP Certificate of Analysis (COA) on a synthesized impurity for use as a reference standard.

Unknown & Trace Impurities

Impurity Isolation

Regis Technologies separations scientist purifies compounds using SFC for impurity isolation. 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 Technologies 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 your 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:

  • ICP-MS
  • LC/MS or LC/MS/MS
  • HPLC and UPLC
  • GC/MS
  • FTIR
  • 1H, 13C, 15N, 19F, & 31P 400 MHz NMR with cryogenic probe enhanced with 2D NMR methods (COSY, HMBC, HSQC, and DEPT 135)
  • High Resolution Mass Spectrometry (HRMS) and elemental analysis
  • Modeling Software (SpartanPro)

Multi-Step Syntheses

Synthesis of Reference Standards

Our Process Research and Development 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.

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