Delhi Lab · NABL TC-7375 · GLP · DSIR · ISO 9001 · Form-37 · COS 23 · MD-40

Pharmaceutical Testing Laboratory in Delhi | NABL Accredited | Arbro Analytical Division

The Arbro Analytical Division Delhi Pharmaceutical Testing Laboratory at Kirti Nagar provides NABL-accredited pharmaceutical testing under ISO/IEC 17025:2017 (Certificate TC-7375) — the broadest pharmaceutical scope in the Auriga lab network with 9,126 NABL accredited entries. The lab covers stability per ICH Q1A, sterility per USP 71, HPLC assay and impurity profiling, nitrosamine testing per ICH M7, benzene testing against CDSCO limits, bacterial endotoxin testing per USP 85, and method validation per ICH Q2(R2), supported by GLP, DSIR, ISO 9001, Form-37, COS 23, and MD-40 credentials.

Get a Quote for Delhi Pharma Testing Call +91 74281 16100

Delhi Lab Address

4/9 Kirti Nagar Industrial Area, New Delhi 110015

NABL Certificate: NABL TC-7375

Validity: Valid until November 2027

Phone: +91 74281 16100

Email: [email protected]

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What the Delhi Lab Tests for Pharmaceuticals

Nine pharmaceutical testing categories confirmed in the Delhi NABL pharmaceutical scope under TC-7375.

Stability Testing (ICH Q1A)

ICH Q1A-compliant accelerated, intermediate, and long-term stability studies with controlled chambers and continuous monitoring.

Sterility Testing (USP 71, IP)

Sterility testing per USP <71> and Indian Pharmacopoeia for sterile pharmaceutical products under ISO Class 5 cleanroom conditions.

HPLC — Assay & Impurity Profiling

HPLC assay, related substances, impurity profiling, and degradation product testing across pharmaceutical matrices.

Nitrosamine Testing (ICH M7)

NDMA, NDEA, and other nitrosamine impurity testing per ICH M7 by LC-MS/MS workflows for active pharmaceutical ingredients and drug products.

Benzene Testing

Benzene residual analysis by GC-MS and GC-Headspace against the CDSCO 2 ppm limit for pharmaceutical and topical preparations.

Bacterial Endotoxin Testing

LAL and rFC (recombinant Factor C) endotoxin testing per USP <85> for parenteral products, water for injection, and medical devices.

Method Validation (ICH Q2(R2))

Analytical method validation per ICH Q2(R2) — specificity, linearity, accuracy, precision, range, LOD/LOQ, and robustness.

Dissolution & Disintegration

USP apparatus dissolution testing and pharmacopoeial disintegration testing for solid and semi-solid dosage forms.

Microbiological Limits

Total aerobic microbial count, total yeast and mould count, specified pathogen detection, and bioburden testing per USP and IP.

Scope note: For US FDA-inspected pharmaceutical testing reports (ANDA, NDA, US dossier submissions), route clients to the Gurugram (Manesar) facility which holds the USFDA Inspected designation.

Key Parameters Tested

The most-requested analytical parameters at the Delhi pharmaceutical testing lab.

Assay & Potency

Quantitative assay of active pharmaceutical ingredients by HPLC, UV, and titrimetric methods against pharmacopoeial limits.

Dissolution

USP apparatus dissolution testing and profiling for solid and semi-solid dosage forms under NABL-accredited conditions.

Stability (ICH Conditions)

Real-time, accelerated, and intermediate stability studies under ICH Q1A-aligned protocols for finished pharmaceutical formulations.

Nitrosamines (NDMA, NDEA)

Nitrosamine impurity testing per ICH M7 by LC-MS/MS for active pharmaceutical ingredients and finished products.

Endotoxin (LAL & rFC)

Bacterial endotoxin testing by LAL and recombinant Factor C (rFC) workflows per USP <85> and IP.

Impurity Profiling

Related substances, degradation impurities, and residual solvent profiling per ICH Q3A, Q3B, and Q3C for regulatory submissions.

Why Use the Delhi Lab for Pharmaceutical Testing

Six reasons pharmaceutical companies across India choose the Delhi flagship lab for analytical and regulatory testing.

Broadest NABL Pharmaceutical Scope (TC-7375)

Delhi TC-7375 holds 9,126 NABL accredited test entries — the broadest pharmaceutical testing scope in the Auriga lab network.

GLP Certified for Non-Clinical Studies

GLP certification for non-clinical analytical work and safety studies where Good Laboratory Practice compliance is required by the receiving authority.

DSIR Recognised

Recognised by the Department of Scientific and Industrial Research (DSIR) for in-house R&D unit status and analytical workflows.

MD-40 for Pharmaceutical Medical Devices

CDSCO Medical Device registration (MD-40) for pharmaceutical-grade medical device testing, biocompatibility, and packaging integrity.

Form-37 Drug Testing Licence

Pharmaceutical drug testing licence under Form-37 for regulatory release testing and CDSCO submissions.

Central Delhi NCR Pharma Coverage

Centrally located for Delhi NCR pharmaceutical manufacturers with rapid sample receipt and digital report delivery through YLIMS.

How It Works

Four steps from initial enquiry to digital report. Standard TAT 5 to 7 working days. Express testing available.

Contact the SPOC

Call your single point of contact at +91 74281 16100 to confirm the test scope, applicable pharmacopoeial standard, and sample submission details.

Drop Off or Courier

Drop the sample at the Kirti Nagar address or send by pre-approved courier. Each sample is bar coded on receipt and registered in YLIMS.

Testing Under NABL Conditions

Testing is conducted under NABL-accredited conditions (TC-7375) with in-process QA checks against the applicable pharmacopoeial standard.

Report via YLIMS

The digital report is issued and accessible via YLIMS. Standard TAT 5 to 7 working days. Express testing available for time-critical batches.

Accreditations and Approvals

Six credentials held at the Delhi facility supporting pharmaceutical testing.

NABL TC-7375

ISO/IEC 17025:2017, Valid Nov 2027

GLP

Good Laboratory Practice certified for non-clinical work

DSIR

Department of Scientific and Industrial Research recognised

ISO 9001

Quality management system certified

Form-37

Pharmaceutical drug testing licence

MD-40

CDSCO Medical Device registration

Related Resources

See the full national pharmaceutical testing scope, route to the Manesar lab for USFDA-inspected requirements, or return to the Delhi lab hub.

Get a Quote for Delhi Pharma Testing

NABL TC-7375 with 9,126 accredited entries. GLP, DSIR, ISO 9001, Form-37, MD-40 credentials. ICH-aligned methods. Standard TAT 5 to 7 working days. Express options available.

+91-7428116100 Get a Quote for Delhi Pharma Testing

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