NABL Accredited · ICH Compliant

Pharmaceutical Impurity Profiling India | ICH Q3D | NABL

Comprehensive pharmaceutical impurity profiling services from an NABL-accredited laboratory in India, covering ICH Q3A, Q3B, Q3C, Q3D, and M7 requirements.

Pharmaceutical impurity profiling is a regulatory imperative for all drug substances and drug products. Auriga Research provides comprehensive impurity profiling services that address the full spectrum of ICH guidelines — organic impurities (Q3A/Q3B), residual solvents (Q3C), elemental impurities (Q3D), and mutagenic impurities (M7). Our NABL-accredited laboratory employs HPLC, LC-MS/MS, GC-HS, and ICP-MS platforms to detect, identify, and quantify impurities at levels well below regulatory thresholds.

For organic impurity profiling, we use stability-indicating HPLC methods with forced degradation studies to map all potential degradation pathways. Unknown impurities exceeding identification thresholds are characterised by LC-MS/MS with accurate mass determination. Elemental impurity analysis per ICH Q3D is performed by ICP-MS with method validation to permitted daily exposure (PDE) limits for all 24 target elements across oral, parenteral, and inhalation routes.

Our impurity profiling services support API release testing, stability studies, process validation, regulatory submissions, and post-approval change assessments. We deliver detailed impurity profile reports with chromatographic data, mass spectral interpretation, and regulatory assessment against applicable thresholds.

Impurity Profiling Capabilities

  • Organic impurity profiling per ICH Q3A (drug substances) and Q3B (drug products)
  • Elemental impurity analysis per ICH Q3D by ICP-MS for all 24 target elements
  • Residual solvent analysis per ICH Q3C by GC-HS
  • Mutagenic impurity testing per ICH M7 by LC-MS/MS at ppm and ppb levels
  • Unknown impurity identification by LC-MS/MS with accurate mass
  • Forced degradation studies for degradation pathway mapping
  • Nitrosamine impurity screening per FDA and EMA guidance
  • Genotoxic impurity assessment and control strategy development

Turnaround Time

Related Substances (HPLC): 7-10 business days
Elemental Impurities (ICP-MS): 7-10 business days
Residual Solvents (GC-HS): 5-7 business days
Comprehensive Impurity Profile: 10-15 business days

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Frequently Asked Questions — Impurity Profiling

What is pharmaceutical impurity profiling?
Pharmaceutical impurity profiling is the systematic identification, characterisation, and quantification of impurities present in drug substances and drug products. It encompasses organic impurities (process-related and degradation products per ICH Q3A/Q3B), inorganic impurities (residual metals per ICH Q3D), and residual solvents (per ICH Q3C). A comprehensive impurity profile ensures patient safety and is mandatory for regulatory submissions.
What ICH guidelines govern impurity profiling?
Several ICH guidelines govern pharmaceutical impurity profiling: ICH Q3A covers impurities in new drug substances, ICH Q3B covers impurities in new drug products, ICH Q3C addresses residual solvents, ICH Q3D addresses elemental impurities, and ICH M7 covers mutagenic impurities. Each guideline defines identification and qualification thresholds based on maximum daily dose, requiring different analytical strategies.
What analytical techniques are used for impurity profiling?
Impurity profiling employs multiple analytical techniques depending on the impurity type. HPLC and UPLC with UV/PDA detection are used for organic impurity quantification. LC-MS/MS is used for structural identification and trace-level genotoxic impurity detection. GC-HS is used for residual solvent analysis per ICH Q3C. ICP-MS is used for elemental impurity determination per ICH Q3D. Each technique is validated to ensure sensitivity at regulatory threshold levels.
What is the turnaround time for impurity profiling?
Standard impurity profiling at Auriga Research is completed within 7-10 business days for routine related substances testing. Comprehensive impurity profiling including organic, inorganic, and residual solvent analysis requires 10-15 business days. Rush services are available for urgent regulatory submissions.

Need Comprehensive Impurity Profiling?

NABL-accredited impurity profiling per ICH Q3A, Q3B, Q3C, Q3D, and M7. Detailed reports for regulatory submissions.

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