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Dr Sahu’s Laboratories

Analytical Services

Ensuring accuracy, reliability, and regulatory compliance in every study — from method development to stability and risk assessment.

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Comprehensive Analytical Support

For pharmaceuticals, biopharma, and medical devices — aligned with ICH, USP, EP, and WHO expectations.

Scope: Method development & validation, impurity profiling, extractables & leachables, nitrosamines, elemental impurities, stability studies, and process risk assessment.
Infrastructure: HPLC, GC/GC-MS, LC-MS/MS, ICP-MS, UV-Vis, FT-IR; GLP-oriented systems, data integrity and traceability.

Our Core Analytical Capabilities

Analytical Method Development

For raw materials, intermediates, APIs, and finished products.

Analytical Method Validation

Performed per ICH Q2(R1) with complete documentation.

Reference & Working Standards

Characterization and qualification of reference/working standards.

Impurity Profiling

For medical devices, drug substances, and formulations.

Extractables & Leachables

Studies for product, packaging, and labeling materials.

Nitrosamine Impurities

Assessment in raw materials, intermediates, APIs, and finished dosage forms.

Genotoxic Impurities

Identification and quantification to ensure product safety.

Elemental Impurities (ICH Q3D)

Heavy metals from process, facilities, and container-closure systems.

Stability Studies

Long-term/accelerated studies per ICH expectations (e.g., Q1A(R2)).

Process Risk Assessment

Comprehensive analytical risk evaluation across lifecycle stages.

Why Choose Dr Sahu’s Laboratories

  • GLP-oriented quality systems; ISO/IEC 17025–aligned approach.
  • State-of-the-art instrumentation and validated workflows.
  • Experienced analytical chemists and domain experts.
  • Data integrity, full traceability, and robust reporting.
  • Regulatory awareness across ICH, WHO, and major pharmacopeias.

Our Workflow

Sample Submission – Intake, chain-of-custody, and test plan finalization.
Method Development – Fit-for-purpose method design & optimization.
Validation & Review – Validation per protocol; QA review of results.
Reporting – Comprehensive CoAs, raw data traceability, and consultation.
Support – Regulatory responses, gap closure, and lifecycle maintenance.

Quality & Compliance

We align with Good Laboratory Practices (GLP) and maintain ISO/IEC 17025–oriented processes.

Our documentation, data integrity controls, and audit trails are designed to support regulatory submissions and inspections.

FAQs

Do you provide method validation as per ICH Q2(R1)?

Yes. We validate according to ICH Q2(R1) with pre-approved protocols, acceptance criteria, and full reports.

Can you assess nitrosamine and genotoxic impurities?

Yes. We offer targeted and non-targeted approaches for identification and quantification across product lifecycle stages.

Do you run extractables and leachables (E&L) studies?

Yes. We evaluate product-packaging interactions, labeling materials, and closure systems for risk-based control.

What stability conditions do you support?

Long-term and accelerated conditions per ICH zones; custom conditions are available on request.

Request a Consultation

Tell us about your product and the scope you need. We’ll propose a fit-for-purpose plan and timelines.

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