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Analytical Services Analytical Services

Analytical Services

Advanced analytical platforms for impurity profiling, chiral resolution, and molecular characterization

At Aurigene Pharmaceutical Services, we specialize in analytical solutions that support every stage of small molecule drug development—from discovery through clinical advancement. Our services are built on a foundation of deep scientific expertise and state-of-the-art instrumentation, enabling precise isolation, purification, and characterization of complex pharmaceutical compounds.

With over 20 years of experience, our team applies advanced chromatographic and spectroscopic techniques to address critical challenges such as impurity profiling, enantioselective resolution, and permeability prediction. Whether you're working with New Chemical Entities, PROTACs, peptides, or nucleosides, we deliver tailored analytical strategies that align with global regulatory expectations and accelerate your development timelines.

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Our Services

HPLC Method Development & Validation (Non-GxP)

  • Development of robust, reproducible methods for APIs, raw materials, and finished products
  • Utilizes HPLC/UPLC systems with PDA, MS, RI, CAD, and ELSD detectors
  • Customized protocols for non-GxP environments to support early-phase development

Chiral & Achiral Separation Solutions via SFC

  • Supercritical Fluid Chromatography (SFC) for rapid, solvent-efficient purification
  • Complimentary compound screening using latest chiral stationary phases
  • Scalable purification from milligrams to hundreds of grams

Impurity Isolation & Characterization

  • Prep HPLC for isolating unknown impurities
  • Structural elucidation using NMR (¹H, ¹³C, DEPT, COSY, HMBC, HSQC), HRMS, IR, LCMS/MS

NMR Spectroscopy & Structural Elucidation

  • 400 MHz instrumentation with multi-nuclear capabilities (¹H, ¹³C, ¹¹B, ¹⁹F, ³¹P)
  • Advanced 1D and 2D techniques: COSY, TOCSY, HSQC, HMBC
  • Quantitative NMR analysis

EPSA (Experimental Polar Surface Area) Analysis

  • SFC-based polarity screening for permeability prediction
  • Ideal for bRo5 compounds including PROTACs, macrocycles, and cyclic peptides
  • Supports early-stage drug design and bioavailability assessment

IAM (Immobilized Artificial Membrane) Chromatography

  • Simulates drug-membrane interactions for lipophilicity and permeability profiling
  • High-throughput screening capability with cost-effective performance
  • Valuable alternative to traditional Log D methods

Specialty Capabilities

  • Mass Directed Purification (MDP) for targeted compound isolation
  • Supercritical Fluid Chromatography (SFC) for both chiral and achira mixture separations
  • Advanced impurity management aligned with ICH thresholds (e.g., >0.1% characterization requirement)
  • Expertise in complex molecules including small peptides, nucleosides, PROTACs, and cyclic compounds
  • Regulatory foresight to mitigate delays in API scale-up and ensure patient safety
  • Multi-technique structural elucidation combining NMR, HRMS, IR, and LCMS/MS for complete molecular insight

Why Choose Aurigene?

Decades of experience in analytical chemistry and pharmaceutical development

Access to cutting-edge instrumentation and purification platforms

Rapid turnaround with flexible scale-up from milligrams to grams

Efficient project management and transparent communication

Supporting drug development programs across continents with precision and reliability

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Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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JANUARY 04, 2021

Role of Peptide Synthesis Based Drugs

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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives

A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...

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Frequently asked questions

How are analytical workflows optimized for high-throughput screening environments?

Automation, rapid chromatographic methods, and multiplexed detection systems are used to increase throughput. Aurigene integrates automated analytical platforms to support fast-paced screening and lead optimization cycles.

How is analytical data quality ensured across large discovery datasets?

Data quality is maintained through validation checks, calibration standards, and automated data processing pipelines. Aurigene ensures consistency by integrating QA practices into high-throughput analytical workflows.

How does analytical chemistry contribute to reducing attrition in drug discovery?

Accurate analytical data ensures that only well-characterized compounds progress through development. Aurigene leverages its analytical expertise to identify risks early, reducing downstream failures and improving success rates.

How is analytical chemistry integrated with medicinal chemistry during SAR studies?

Analytical data confirms compound identity and purity for each SAR iteration, ensuring reliable biological activity data. Rapid analytical feedback enables faster design–make–test cycles.

How are analytical errors minimized in high-throughput environments?

Analytical errors are minimized through automation, standardized workflows, and system checks that ensure consistent data generation across large datasets. Aurigene applies automated platforms with built-in quality controls to maintain accuracy and reliability in high-throughput discovery workflows.

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