NABL Accredited CDSCO Approved USFDA Inspected (Manesar & Bangalore)

Raw Material Testing for Pharmaceuticals | APIs and Excipients | NABL | Auriga Research

Pharmaceutical raw material testing is the first quality gate in the drug manufacturing process. Every API and excipient entering a facility must be tested against pharmacopoeial or in-house specifications before release for production. Auriga Research provides NABL-accredited raw material testing covering identity, purity, assay, impurities, moisture, microbial quality, and physical characterisation per IP, USP, EP, BP, and JP monographs. Testing is delivered across all 5 Auriga labs with USFDA Inspected status at Manesar and Bangalore.

For APIs, the testing scope includes identification by FTIR, HPLC, and NMR where required, assay by HPLC or titration, related substances per ICH Q3A(R2), residual solvents per ICH Q3C(R8) by GC headspace, elemental impurities per ICH Q3D(R2) (effective 24 September 2022, with R2 PDEs for Gold, Silver, and Osmium) by ICP-MS, water content by Karl Fischer, and polymorphic form confirmation by XRD or DSC. For excipients, identity, functional properties, microbial limits, and critical quality attributes specific to each material's role in the formulation are covered.

Auriga supports pharmaceutical manufacturers, contract manufacturing organisations (CMOs), and API producers with reliable incoming material testing that meets cGMP documentation requirements. 9,226 reference standards in active inventory eliminate sourcing delays. Test reports include certificate of analysis (CoA) with raw data traceability, pharmacopoeial compliance statements, and electronic delivery formatted for direct CDSCO, USFDA, EMA, and PMDA submission — without re-testing.

Multi-Platform Coverage in One Lab Network

FTIR at 3 labs (Delhi, Manesar, Bangalore) · HPLC at all 5 labs with 110+ systems and 605 columns in active stock · ICP-MS at 3 labs (Delhi, Baddi, Bangalore) for ICH Q3D(R2) elemental impurities · 9,226 reference standards in inventory — no procurement delays at quote stage. Single organisation for identity, purity, elemental, and residual-solvent testing.

Standard pharmacopoeial 5 to 7 business days | Rush 2 to 3 days | Comprehensive API 7 to 10 days

Get a Quote Call +91-7428116100

Six Raw Material Testing Services

Each card maps the service to the analytical method, the governing pharmacopoeial or ICH reference, and the Auriga lab where it is performed.

Identity

API Identity Testing

Identity testing by FTIR, HPLC, NMR (where required), UV, melting point, and specific rotation per IP, USP, EP, BP, and JP monographs. FTIR available at Delhi, Manesar, and Bangalore.

Assay

API Purity & Assay by HPLC

Assay and purity determination by HPLC per pharmacopoeial monograph. 110+ HPLC and UPLC systems across all 5 labs with 605 chromatography columns in active stock.

Q3D(R2)

Elemental Impurity Testing

All 24 ICH Q3D(R2) target elements by ICP-MS — including the R2 Gold, Silver, and Osmium PDEs. 5 ICP-MS units across Delhi, Baddi, and Bangalore.

Q3C(R8)

Residual Solvent Analysis

Class 1, 2, and 3 residual solvent quantification per ICH Q3C(R8) by GC headspace and GC-MS against PDE-derived specification limits.

Excipient

Excipient Testing per Pharmacopoeia

Pharmaceutical excipient testing per IP, USP, EP, BP, and JP monographs — identity, functional properties, moisture content, microbial limits, and physical characterisation.

Supplier Q

Supplier Qualification Testing

Comparative testing for new API and excipient sources during supplier qualification. Full pharmacopoeial release plus side-by-side reference comparison against the approved supplier.

Project Timelines

Indicative TAT from sample receipt. Confirm exact timeline with your SPOC at quote stage based on test scope and sample queue.

Service Type	Turnaround Time
Standard Pharmacopoeial Testing (API or excipient)	5 to 7 business days
Rush Testing (established method)	2 to 3 business days
Comprehensive API Characterisation (Q3A + Q3C + Q3D)	7 to 10 business days
Excipient Testing Package (physical + chemical + micro)	5 to 7 business days
Supplier Qualification (side-by-side comparison)	10 to 14 business days

How It Works

Get a Quote

Share the raw material name, grade, and pharmacopoeial specification (IP, USP, or EP). Your SPOC confirms applicable tests and whether full monograph or selected tests are needed.

Collect and Send Your Sample

Prepare 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 Raw Material Testing

Pharma manufacturers conducting incoming QC on API and excipient batches before manufacturing release.
Generic developers characterising reference standards and starting materials for ANDA submissions.
CDMO clients requiring raw material release testing before formulation development or scale-up.
Companies establishing supplier qualification for new API sources or alternative excipient vendors.
API manufacturers preparing drug master file (DMF) data with full pharmacopoeial release packages.
Excipient suppliers issuing CoAs to drug-product customers under contract testing arrangements.
QC teams running ICH Q3D(R2) elemental impurity Risk Assessment confirmatory testing.
Importers requiring CDSCO incoming raw material testing for registration and renewal dossiers.

Why Auriga for Raw Material Testing

FTIR + HPLC + ICP-MS Multi-Platform Coverage

FTIR at 3 labs, HPLC at all 5 labs (110+ systems, 605 columns), ICP-MS at 3 labs. Single organisation for identity, purity, elemental, and residual-solvent testing — no need to split work.

9,226 Reference Standards in Inventory

Active reference-standard inventory eliminates procurement delays at quote stage. NIST-traceable, pharmacopoeial, and impurity reference standards stocked across the lab network.

USFDA Inspected at Manesar & Bangalore

Raw material data generated at Manesar and Bangalore is accepted in USFDA dossier submissions without re-testing. Both labs are USFDA Inspected.

ICH Q3D(R2) + Q3C(R8) Current-Revision Reports

All reports cite the current active ICH revisions — Q3D(R2) effective September 2022 (Gold, Silver, Osmium PDEs) and Q3C(R8) for residual solvents. Submissions filed without re-revision risk.

Full Pharmacopoeial Scope: IP USP EP BP JP

Testing against all major pharmacopoeial monographs in one accredited NABL scope. Multi-pharmacopoeia harmonisation supported for multi-market dossier work.

In-House Specification Testing Alongside Compendial

Client in-house specifications, supplier-issued specifications, and tightened internal release criteria all in scope — combined with pharmacopoeial release in a single CoA.

NABL Accredited Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group · Auriga Research

Regulatory References

• IP, USP, EP, BP, JP — Pharmacopoeial monographs for API and excipient identity, assay, related substances, and physical properties.
• ICH Q3A(R2) — Impurities in New Drug Substances.
• ICH Q3C(R8) — Residual Solvents (Class 1, 2, 3 with PDE limits).
• ICH Q3D(R2) — Elemental Impurities, effective 24 September 2022. R2 PDEs for Gold (Au), Silver (Ag), Osmium (Os).
• USP <61> / <62> — Microbial enumeration and specified organism tests for non-sterile raw materials.
• ICH Q2(R2) — Validation of Analytical Procedures (March 2024).

Related Services

Frequently Asked Questions

What does pharmaceutical raw material testing include?

Pharmaceutical raw material testing includes identity testing (FTIR, UV, melting point, HPLC, and NMR where required), assay and purity determination by HPLC or titration, related substances and impurity profiling per ICH Q3A(R2), residual solvent analysis per ICH Q3C(R8), heavy metals and elemental impurity testing per ICH Q3D(R2) by ICP-MS, moisture content by Karl Fischer, microbial limits per USP 61 and 62, and physical characterisation (particle size, bulk density, flowability). Testing is performed against pharmacopoeial monographs (IP, USP, EP, BP, JP) or in-house specifications.

Which ICH revisions does Auriga cite on raw material reports?

All raw material reports cite the current active ICH revisions: ICH Q3A(R2) for impurities in new drug substances, ICH Q3B(R2) for drug products, ICH Q3C(R8) for residual solvents, ICH Q3D(R2) for elemental impurities (effective 24 September 2022, with new PDEs for Gold (Au), Silver (Ag), and Osmium (Os)), and ICH M7(R2) for mutagenic impurities. Submissions still referencing Q3D(R1) or Q3C earlier revisions should be updated before filing.

Why is raw material testing important in pharmaceutical manufacturing?

Raw material testing ensures that APIs and excipients meet predefined quality specifications before they enter the manufacturing process. Substandard raw materials can compromise product quality, safety, and efficacy. Regulatory agencies including CDSCO, USFDA, EMA, and PMDA require documented evidence that all incoming materials are tested and approved per cGMP requirements. Raw material testing prevents batch failures, recall events, and regulatory non-compliance — and is the foundation of supplier qualification programmes.

Which Auriga labs perform raw material testing?

Raw material testing is delivered across all 5 Auriga labs: Delhi HQ (Arbro Analytical Division), Manesar (USFDA Inspected — anchors method development and validation), Bangalore (USFDA Inspected — high-volume routine testing), Baddi (HPLC + UPLC + ICP-MS), and Bahadurgarh (HPLC for specialty work). FTIR is available at 3 labs (Delhi, Manesar, Bangalore). HPLC is available at all 5 labs (110+ systems with 605 chromatography columns in active stock). ICP-MS is available at 3 labs (Delhi, Baddi, Bangalore). Auriga maintains an inventory of 9,226 reference standards — eliminating sourcing delays at quote stage.

What sample quantity is required for a standard API pharmacopoeial testing package?

For a standard API pharmacopoeial release package — identity, assay, related substances, residual solvents per ICH Q3C(R8), water content, residue on ignition, elemental impurities per ICH Q3D(R2), and microbial limits — we typically require 25 to 50 g of the API. A reduced scope (identity, assay, related substances, water content only) can be completed on 10 to 15 g. For polymorph confirmation by XRD or DSC, an additional 1 to 2 g is sufficient. For excipient pharmacopoeial packages, 50 to 100 g is recommended given the wider physical-property scope. Confirm the exact quantity for your specific monograph and tests with our QC team before despatch.

Can Auriga test raw materials against in-house client specifications in addition to pharmacopoeial monographs?

Yes. While Auriga routinely tests against IP, USP, EP, BP, and JP pharmacopoeial monographs, the team also tests against client in-house specifications, supplier-issued specifications, and tightened internal release criteria. The specification document should list each parameter, its test method or method reference, the acceptance criteria, and the version / effective date. Where the in-house method differs from the standard validated method, the client method is qualified through a brief verification exercise or, where compendial equivalence applies, the compendial method is run and reported against your specification limits. Both pharmacopoeial and in-house specification testing can be combined in a single CoA.

What is the turnaround time for raw material testing?

Standard raw material testing is completed within 5 to 7 business days for routine pharmacopoeial testing. Comprehensive API characterisation including impurity profiling per ICH Q3A(R2), residual solvents per ICH Q3C(R8), elemental impurities per ICH Q3D(R2), and physical properties requires 7 to 10 business days. Rush testing is available within 2 to 3 business days for urgent incoming material release.

Get a Quote for Raw Material Testing

NABL-accredited API and excipient testing per IP, USP, EP, BP, and JP. ICH Q3D(R2) elemental impurities by ICP-MS, ICH Q3C(R8) residual solvents by GC-MS. FTIR at 3 labs, HPLC at all 5 labs, ICP-MS at 3 labs. 9,226 reference standards in inventory. USFDA Inspected at Manesar and Bangalore.

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