NABL Accredited · Pharmacopoeial Testing

Pharmaceutical Raw Material Testing India | API & Excipient | NABL

Comprehensive raw material testing for pharmaceutical APIs and excipients from an NABL-accredited laboratory in India.

Pharmaceutical raw material testing is the first quality gate in the drug manufacturing process. Every API and excipient entering your facility must be tested against pharmacopoeial or in-house specifications before release for production. Auriga Research provides NABL-accredited raw material testing services covering identity, purity, assay, impurities, moisture, microbial quality, and physical characterisation per IP, USP, EP, BP, and JP monographs.

For APIs, our testing scope includes identification by IR spectroscopy, assay by HPLC or titration, related substances profiling, residual solvents by GC-HS, elemental impurities by ICP-MS, water content by Karl Fischer, and polymorphic form confirmation by XRD or DSC. For excipients, we test identity, functional properties, microbial limits, and critical quality attributes specific to each material's role in the formulation.

Our laboratory supports pharmaceutical manufacturers, contract manufacturing organisations (CMOs), and API producers with reliable incoming material testing that meets cGMP documentation requirements. Test reports include certificate of analysis (CoA), raw data traceability, and pharmacopoeial compliance statements.

Raw Material Testing Capabilities

  • Identity testing by IR, UV, melting point, and specific rotation
  • Assay determination by HPLC, UPLC, or volumetric titration
  • Related substances and impurity profiling per pharmacopoeial monographs
  • Residual solvent analysis per ICH Q3C by GC-HS
  • Elemental impurity testing per ICH Q3D by ICP-MS
  • Moisture content by Karl Fischer titration and loss on drying
  • Microbial limits testing per USP <61> and <62>
  • Physical characterisation — particle size, bulk density, flowability, pH

Turnaround Time

Standard Pharmacopoeial Testing: 5-7 business days
Rush Testing: 2-3 business days
Comprehensive API Characterisation: 7-10 business days
Excipient Testing Package: 5-7 business days

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Frequently Asked Questions — Raw Material Testing

What does pharmaceutical raw material testing include?
Pharmaceutical raw material testing includes identity testing (IR, UV, melting point), assay and purity determination by HPLC or titration, related substances and impurity profiling, residual solvent analysis, heavy metals and elemental impurity testing, moisture content by Karl Fischer, microbial limits testing, and physical characterisation (particle size, bulk density, flowability). Testing is performed against pharmacopoeial monographs (IP, USP, EP, BP, JP) or in-house specifications.
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, FDA, and EMA 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.
What is the turnaround time for raw material testing?
Standard raw material testing at Auriga Research is completed within 5-7 business days for routine pharmacopoeial testing. Comprehensive API characterisation including impurity profiling and physical properties requires 7-10 business days. Rush testing is available within 2-3 business days for urgent incoming material release.

Need Raw Material Testing for Your Pharmaceutical Operations?

NABL-accredited API and excipient testing per IP, USP, EP, BP pharmacopoeias. Reliable incoming material release within 5-7 business days.

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