Impurity Profiling in Pharmaceuticals | ICH Q3A Q3B Q3C Q3D | NABL | Auriga Research
Pharmaceutical impurity profiling is a regulatory imperative for all drug substances and drug products. Auriga Research provides comprehensive impurity profiling that addresses the full spectrum of ICH guidelines — organic impurities per ICH Q3A(R2) and Q3B(R2), residual solvents per ICH Q3C(R8), elemental impurities per ICH Q3D(R2) (effective 24 September 2022), and mutagenic and nitrosamine impurities per ICH M7(R2). The NABL-accredited laboratory network employs HPLC, UPLC, LC-MS/MS, GC-MS, GC headspace, and ICP-MS platforms to detect, identify, and quantify impurities at levels well below regulatory thresholds.
ICH Q3D(R2) introduced new permitted daily exposure (PDE) limits for Gold (Au), Silver (Ag), and Osmium (Os), updated the cutaneous and transcutaneous PDE framework, and corrected several editorial inconsistencies in the R1 text. All elemental impurity reports issued from September 2022 onwards cite Q3D(R2). All 24 target elements — including the R2-revised Gold, Silver, and Osmium PDEs — are quantified in a single ICP-MS run with sub-ppt detection across most analytes.
Impurity profiling services support API release testing, stability studies, process validation, regulatory submissions, and post-approval change assessments. Method development and validation per ICH Q2(R2) (March 2024) and ICH Q14 (2023) is anchored at Manesar (Plot 136, Sector 5, IMT Manesar) — the USFDA Inspected facility. Detailed impurity profile reports include chromatographic and mass-spectral data, structural assignments, and regulatory assessment against applicable ICH thresholds — formatted for CDSCO, USFDA, EMA, and PMDA submission without modification.
All Four ICH Q3 Guidelines + ICH M7 Under One Roof
ICH Q3A(R2) · Q3B(R2) · Q3C(R8) · Q3D(R2) · M7(R2) — covered in one organisation. HPLC, LC-MS/MS, ICP-MS, and GC-MS/MS all in-house across the lab network. No need to split different impurity types across different vendors. USFDA Inspected at Manesar and Bangalore. One sample submission, one consolidated NABL report.
Six Impurity Profiling Services
Each card maps the impurity class to the governing ICH guideline, the analytical method, and the Auriga lab where it is performed.
Organic Impurity Profiling
Organic impurity profiling per ICH Q3A(R2) and Q3B(R2) by HPLC, UPLC, and LC-MS/MS. Stability-indicating methods with forced-degradation pathway mapping. All 5 labs.
Elemental Impurity Testing by ICP-MS
All 24 ICH Q3D(R2) target elements by ICP-MS — including the R2-revised Gold (Au), Silver (Ag), and Osmium (Os) PDEs. 5 ICP-MS units across Delhi, Baddi, Bangalore.
Residual Solvent Analysis
Class 1, 2, and 3 residual solvent quantification per ICH Q3C(R8) by GC-MS and GC headspace against PDE-derived specification limits.
Nitrosamine Impurity Screening
Nitrosamine and NDSRI screening by LC-MS/MS and GC-MS/MS per ICH M7(R2), FDA Guidance Rev 2 (Sep 2024), and the FDA NDSRI RAIL Guidance (Aug 2023). Delhi, Bangalore, Manesar.
Genotoxic Impurity Assessment
Mutagenic impurity assessment per ICH M7(R2) and the TTC (Threshold of Toxicological Concern) approach. CPCA-based control strategy support and in silico screening interpretation.
Related Substance & Degradation Product Profiling
Related substance and degradation product profiling per ICH Q3B(R2). Forced degradation under acid, base, oxidative, photolytic, and thermal stress with stability-indicating method verification.
Project Timelines
Indicative TAT from sample receipt. Confirm exact timeline with your SPOC at quote stage based on impurity class, method status, and sample queue.
| Service Type | Turnaround Time |
|---|---|
| Related Substances by HPLC (ICH Q3A / Q3B) | 7 to 10 business days |
| Elemental Impurities by ICP-MS (ICH Q3D(R2)) | 7 to 10 business days |
| Residual Solvents by GC-HS (ICH Q3C(R8)) | 5 to 7 business days |
| Nitrosamine / Genotoxic Screening (ICH M7(R2)) | 10 to 15 business days |
| Comprehensive Impurity Profile (all classes) | 10 to 15 business days |
| Method Development + Validation (ICH Q2(R2)) | 4 to 6 weeks |
How It Works
Get a Quote
Share your compound class, synthesis route, and which ICH Q3 guideline applies. Your SPOC confirms which impurity classes require testing and the appropriate method.
Collect and Send Your Sample
Prepare sample per SPOC instructions at quote stage. Each sample is bar coded and registered in YLIMS on receipt.
Testing and QA Review
Your sample is tested under NABL-accredited conditions. Results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.
Receive Your NABL Report
Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.
Who Needs Impurity Profiling
- Pharma manufacturers preparing impurity data packages for CDSCO or USFDA dossier submission.
- API manufacturers characterising impurity profiles per ICH Q3A(R2) for drug master file (DMF) inclusion.
- Generic developers needing related substance profiles for ANDA submissions and registration renewals.
- Stability teams tracking impurity growth during ICH Q1A(R2) accelerated and long-term stability studies.
- Companies running ICH Q3D(R2) elemental impurity risk assessments with the R2 Gold, Silver, Osmium PDEs.
- Topical and transdermal product manufacturers needing cutaneous and transcutaneous Q3D(R2) PDE reporting.
- Companies running ICH M7(R2) nitrosamine risk assessments and Step 2 confirmatory testing.
- Regulatory affairs teams compiling Module 3 impurity sections for CTD submission across all four ICH Q3 guidelines.
Why Auriga for Impurity Profiling
All Four ICH Q3 + ICH M7 In One Lab
Covers ICH Q3A(R2), Q3B(R2), Q3C(R8), Q3D(R2), and M7(R2) in one organisation. No need to split organic, elemental, residual solvent, and mutagenic impurity testing across different vendors.
HPLC + LC-MS/MS + ICP-MS + GC-MS/MS All In-House
Multi-technique platform across the lab network: 110+ HPLC and UPLC systems, 9 LC-MS/MS units, 5 ICP-MS units, and GC-MS/MS with headspace. Single consolidated NABL report.
USFDA Inspected at Manesar and Bangalore
Impurity profiling data from Manesar and Bangalore — both USFDA Inspected facilities — accepted in USFDA dossier submissions without re-testing.
ICH Q3D(R2) Compliant Since September 2022
All elemental impurity reports issued from 24 September 2022 onwards cite Q3D(R2), including the new Gold, Silver, and Osmium PDEs and the cutaneous and transcutaneous route framework.
ICH M7(R2) Nitrosamine + Genotoxic Framework
Mutagenic impurity assessment per ICH M7(R2), nitrosamine screening per FDA Rev 2 (Sep 2024), and NDSRI testing per the FDA NDSRI RAIL Guidance (August 2023). Method development at Manesar (USFDA Inspected).
NABL Reports Accepted by CDSCO, USFDA, EMA
NABL accredited (ISO/IEC 17025:2017) impurity profiles accepted by CDSCO regulatory submissions, USFDA dossier inclusion, EMA filings, and PMDA submissions — without re-testing.
5+
NABL Accredited Labs
5 Cities
Delhi · Manesar · Bahadurgarh · Baddi · Bangalore
12,000+
Clients Served
1985
Arbro Group · Auriga Research
Regulatory References
- • ICH Q3A(R2) — Impurities in New Drug Substances.
- • ICH Q3B(R2) — Impurities in New Drug Products.
- • ICH Q3C(R8) — Residual Solvents (Class 1, 2, 3 with PDE limits).
- • ICH Q3D(R2) — Elemental Impurities, effective 24 September 2022. New PDEs for Gold (Au), Silver (Ag), Osmium (Os); cutaneous and transcutaneous route framework.
- • ICH M7(R2) — Assessment and Control of DNA Reactive (Mutagenic) Impurities, including nitrosamines.
- • FDA Guidance Rev 2 (September 2024) — Control of Nitrosamine Impurities in Human Drugs.
- • FDA NDSRI RAIL Guidance (August 2023) — Acceptable Intake Limits for NDSRIs.
- • ICH Q2(R2) — Validation of Analytical Procedures (March 2024).