NABL CDSCO USFDA Inspected — Manesar & Bangalore IP · USP · EP · BP · JP

Excipient Testing Services | IP USP EP Monographs | NABL Accredited | Auriga Research

NABL-accredited excipient testing across IP, USP, EP, BP and JP monographs — identity (FTIR), purity/assay (HPLC), elemental impurities per ICH Q3D(R2) (ICP-MS), residual solvents per ICH Q3C(R8) (GC-HS) and microbiology (USP <61>/<62>). Backed by 9,226 reference standards.

Multi-Platform Excipient Coverage Across the Auriga Network

  • · FTIR at 3 labs — Delhi, Manesar, Bangalore for identity
  • · HPLC and UPLC at all 5 labs — 110+ systems with 605 chromatography columns for purity and assay
  • · ICP-MS at 3 labs — Delhi, Baddi, Bangalore (5 systems) for ICH Q3D(R2) elemental impurities
  • · 9,226 active reference standards — IP, USP, EP, BP and JP monograph standards on-shelf for immediate use

Excipient testing is essential to ensure the material used in pharmaceutical formulations does not compromise product quality, performance or patient safety. Excipients are not inert ingredients in modern drug products — they affect compressibility, disintegration, dissolution, stability and drug release. Trusted excipient quality control starts with pharmacopoeial compliance per IP, USP, EP, BP and JP monographs and extends to the functional attributes that matter in your formulation. Auriga Research provides NABL-accredited excipient testing across all five Auriga labs with FTIR identity, HPLC and UPLC purity/assay, ICP-MS elemental impurity work per ICH Q3D(R2), GC headspace residual solvent screening per ICH Q3C(R8) and USP <61>/<62> microbiology.

Our laboratory tests excipients against IP, USP, EP, BP and JP monographs where available, and against client-specific specifications when required. We combine chemical analysis, physical property evaluation and microbial quality testing to deliver a complete excipient profile for incoming material release, vendor qualification and formulation development. The 9,226 active reference standards inventory accelerates pharmacopoeial work that would otherwise wait on external standard sourcing — particularly valuable for excipient monographs across IP, USP, EP, BP and JP.

Reports from Auriga Research are designed for regulatory and manufacturing use. Each excipient testing package includes a certificate of analysis, raw data traceability and commentary on compliance with pharmacopoeial limits and functional quality requirements. Reports cite the current ICH revisions — Q3D(R2), Q3C(R8) and Q2(R2) — so excipient evidence stays submission-ready for CDSCO, USFDA and EMA filings without R&D rework.

Excipient Testing Services

Each service mapped to its pharmacopoeial monograph or current ICH revision for quick QC and dossier scoping.

FTIR/HPLC

Excipient Identity Testing

Identity testing by FTIR (Delhi, Manesar, Bangalore) and HPLC per IP, USP, EP, BP and JP excipient monographs — unambiguous identification against pharmacopoeial reference standards.

Assay

Excipient Purity & Assay

Purity and assay testing per pharmacopoeial monograph by HPLC, UPLC, UV and titrimetric methods — backed by Auriga’s 9,226 active reference standards.

ICH Q3D(R2)

Elemental Impurity Testing

Elemental impurity testing per ICH Q3D(R2) by ICP-MS — 24 target elements quantified against route-specific PDE limits with the revised PDEs for Gold (Au), Silver (Ag), Osmium (Os) and the cutaneous / transcutaneous route limits introduced in R2.

ICH Q3C(R8)

Residual Solvent Analysis

Residual solvent analysis per ICH Q3C(R8) by GC headspace — Class 1, Class 2 and Class 3 solvents quantified per USP <467> against current Q3C(R8) PDE limits.

USP <61>/<62>

Microbiological Testing

Microbiological testing per USP <61> (microbial enumeration) and USP <62> (specified microorganisms) and EP — total aerobic count, yeasts and moulds, objectionable organisms.

DSC + HPLC

Excipient–API Compatibility

Excipient compatibility studies with API by DSC (at Manesar) and HPLC — comparative thermograms and forced-degradation profiles to flag thermal or chemical interactions early in formulation development.

How It Works — 4 Steps to Your NABL Excipient Report

1

Get a Quote

Share excipient name, grade, pharmacopoeial specification (IP, USP, EP, BP or JP) and whether you need full monograph compliance or selected parameters. Your SPOC confirms tests and sample requirement.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody.

3

Testing and QA Review

Tested under NABL-accredited conditions across FTIR, HPLC, ICP-MS, GC-HS, KF and microbiology as required by the agreed scope. Results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for CDSCO, USFDA and regulatory submission with current ICH revisions cited (Q3D(R2), Q3C(R8), Q2(R2)). Track via YLIMS.

Typical Turnaround Time

Package Turnaround Time
Standard Excipient Testing (identity + assay + KF) 5-7 business days
Rush Testing 2-3 business days
ICH Q3D(R2) Elemental Impurity Panel 5-7 business days
ICH Q3C(R8) Residual Solvent Panel 5-7 business days
Microbial Limits Testing (USP <61>/<62>) 7-10 business days
Full Pharmacopoeial Compliance (ID + Assay + Q3D(R2) + Q3C(R8) + Micro) 7-10 business days

Who Needs Excipient Testing

  • ✓ Pharma manufacturers conducting incoming QC on excipient batches before manufacturing
  • ✓ Generic developers characterising excipients as part of formulation development and ANDA filings
  • ✓ CDMO clients requiring excipient release testing before batch manufacturing
  • ✓ Companies establishing new excipient suppliers needing qualification data and CoA documentation
  • ✓ Excipient suppliers documenting batch consistency for cGMP drug product applications
  • ✓ Innovator pharma compiling CTD Module 3.2.S.4 (Control of Excipients) packages
  • ✓ Bulk drug and API manufacturers preparing vendor qualification dossiers
  • ✓ Regulatory affairs teams supporting excipient specification submissions across CDSCO, USFDA and EMA

Why Auriga for Excipient Testing

FTIR at 3 Labs · HPLC at All 5 Labs

FTIR at Delhi, Manesar and Bangalore and HPLC across all 5 labs (110+ systems, 605 columns) — no backlog or queue for identity and purity testing during high-volume release windows.

9,226 Reference Standards In-House

9,226 active reference standards covering IP, USP, EP, BP and JP monograph excipients — pharmacopoeial testing without delays waiting on external standard sourcing.

ICP-MS at 3 Labs for ICH Q3D(R2)

ICP-MS systems at Delhi, Baddi and Bangalore (5 instruments) for elemental impurity testing per ICH Q3D(R2) — full 24-element panel with the R2 Au, Ag, Os PDEs on every report.

USFDA Inspected — Manesar & Bangalore

Auriga Manesar and Bangalore are USFDA Inspected facilities — excipient release data is accepted in ANDA filings, USFDA dossier submissions and EMA filings without re-testing.

Current ICH Revisions on Every Report

Reports cite Q3D(R2), Q3C(R8) and Q2(R2) — the current ICH revisions, not the superseded bare Q3D / Q3C / Q2(R1). Submission-ready evidence without R&D rework.

Full IP, USP, EP, BP, JP Coverage

NABL ISO/IEC 17025:2017 accredited scope covers IP, USP, EP, BP and JP excipient monographs in one network — one SPOC, one report, regardless of submission pharmacopoeia.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

Related Testing Services

Raw Material Testing Impurity Profiling Elemental Analysis Finished Product Testing NABL Accredited Lab All Pharma Testing →

Frequently Asked Questions — Excipient Testing

What types of excipients does Auriga test?
We test pharmaceutical excipients used in tablets, capsules, oral liquids, topicals and parenterals — including diluents, binders, disintegrants, lubricants, coatings, film formers, solubilizers, preservatives and functional polymers. Testing is performed against IP, USP, EP, BP and JP pharmacopoeial monographs or against client-specific quality specifications.
Which ICH revisions does Auriga cite on excipient reports?
Auriga cites the current ICH revisions on all excipient release and qualification reports: ICH Q3D(R2) for elemental impurities (effective September 2022, with R2 PDEs for Gold, Silver and Osmium), ICH Q3C(R8) for residual solvents (current revision), and ICH Q2(R2) for analytical procedure validation (March 2024 — supersedes Q2(R1)). Reports do not use the superseded bare Q3D, Q3C or Q2(R1) wording.
Which methods are used for excipient testing?
Excipient testing at Auriga Research uses pharmacopoeial and validated in-house methods including FTIR (3 labs — Delhi, Manesar, Bangalore), HPLC and UPLC (110+ systems across all 5 labs with 605 chromatography columns), ICP-MS for elemental impurities per ICH Q3D(R2) (5 systems at Delhi, Baddi and Bangalore), GC headspace for residual solvents per ICH Q3C(R8), Karl Fischer, viscosity measurement, particle size analysis and microbial limits testing per USP <61>/<62>. The 9,226 active reference standards inventory accelerates pharmacopoeial work that would otherwise wait on external standard sourcing.
Do you support excipient release testing for pharmaceutical manufacturing?
Yes. We provide NABL-accredited excipient release testing for incoming material quality control, vendor qualification and regulatory submissions. Our reports include certificate of analysis, raw data traceability and compliance with IP, USP, EP, BP or client-defined specifications. USFDA Inspected at Manesar and Bangalore — data is accepted in ANDA filings and USFDA dossier submissions.
How long does excipient testing take?
Standard excipient testing is completed within 5-7 business days. Rush testing is available in 2-3 business days for urgent material release or development support, depending on the specific test package and sample readiness. Full pharmacopoeial monograph compliance (identity + assay + ICH Q3D(R2) elemental + ICH Q3C(R8) residual solvents + USP <61>/<62> microbial) runs 7-10 business days.

Need Excipient Testing for Your Pharmaceutical Products?

NABL-accredited pharmacopoeial and functional property analysis for excipient release. IP, USP, EP, BP and JP monographs with ICH Q3D(R2) and Q3C(R8) on every report — formatted for CDSCO, USFDA and EMA submissions.

+91-7428116100 Get a Quote
Call Now Get a Quote

Type to search services, tests, and locations…