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Pharmaceutical Analytical Chemistry Services Pharmaceutical Analytical Chemistry Services

Pharmaceutical Analytical Chemistry Services

Aurigene brings over two decades of experience in providing analytical chemistry services by ensuring that every method meets the process requirements for APIs and formulations.

We provide analytical services for NCEs, APIs and formulation of DS and DP. We are well equipped with high-end instruments for purification like Mass Directed Purification (MDD) and Supercritical Fluid Chromatography (SFC). We also facilitate impurity identification, characterization and isolation. We provide end-to-end support for analytical services. The state-of-the-art infrastructure at our R and D centers is well-equipped with the latest analytical instruments that enable us to provide high-quality, cost-effective services for our customers.

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Our Custom Services

  • Purity of enantiomers
  • Identification of related substances and assay
  • Prep purification
  • Mass directed purification
  • Supercritical Fluid Chromatography (SFC)
  • Method development for non-chromophoric compounds
  • Fate and purge studies
  • Genotoxic Impurity (GTI) studies
  • Impurity isolation and characterization
  • Assay, dissolution, content uniformity and impurities content studies

Analytical Instrumentation

  • SFC
  • DSC, FT-IR
  • HPLC with VWD, DAD, ELSD, CAD and RID
  • UPLC with VWD and DAD
  • LC-MS/MS triple quard
  • GC and GC-HS
  • NMR 400 MHz
  • Amino Acid Analyzer
  • UV-VIS Spectrophotometer
  • FT-IR Spectrophotometer
  • Polarimeter
  • Auto-titrator and KF Apparatus
  • Differential Scanning Calorimeter
  • Thermo Gravimetric Analyzer


  • Reverse phase
  • Normal phase
  • Chiral


  • Identification
  • Physiochemical
  • Structure elucidation
  • Impurity profiling or characterization

Analytical Methods

  • Analytical method development
  • Analytical method validation
  • Analytical methoxy transfer
  • Analytical method optimization


  • Genotoxicity impurities
  • Nitosin impurities

Stability Studies

  • Drug substance
  • Impartial stability study
  • Whole time stability study

Why Aurigene Pharmaceutical Services?

Hyphenated analytical instruments

Experience in handling complex molecules

Strong data integrity and digitization

End-to-end support for analytics

Virtual Tour

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Role of Peptide Synthesis Based Drugs

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Technology meets sustainability - How a complex API development process goes green

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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

What experience does Aurigene have with Pharmaceutical Analytical Services?

  • Analytical method development, method validation, and method transfer of Key Starting Materials ( KSM), Intermediates and drug substance. We also have experience in developing and validating following analytical methods.
    • Purity/Related substances/Assay by HPLC
    • Purity/Related substances/Assay by GC
    • Residual solvents by GC/GC-HS
    • Impurity profiling by HPLC/GC/LC-MS/GC-MS
    • Identification and characterization, quantification of impurities by LC-MS/GC-MS & NMR
    • Trace level elemental impurities identification and quantification by ICP-MS
    • Genotoxic impurities
  • Cleaning method development and validation
  • Holding study/stability studies
  • Hygroscopic study (EP/USP)
  • Melting point determination/identification of different polymorphs/determination of Glass transition temperatures by DSC
  • Safety studies for the reaction mass samples by DSC
  • Thermogravimetric analysis for the samples (TGA)
  • Trace level ions determination by Ion chromatography
  • Particles size distribution (PSD)
  • Purification/isolation of impurities and characterization
  • Purification/isolation of desired compounds
  • Amino acids analysis
  • Peptide analysis
  • CMC activities (establishment of Physico-chemical properties for the regulatory submission)

Which samples can be analyzed at Aurigene?

We can analyze the below development samples related to

  • Testing of raw materials
  • Testing of in-process samples
  • Testing of intermediates
  • Testing of drug substance

Which guidelines does Aurigene use to perform method validation?

Below are the set of guidelines used for method validation

<1225>&<1226> US Pharmacopoeia chapter
CDER Guidance Guideline for Submitting Samples and Analytical Data for Methods Validation. February 1987.
CDER Reviewer Guidance Validation of Chromatographic methods. November 19
ICH Q2 (R1) Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization
ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonization.
ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients, International Conference on Harmonization.
RDC.N°17 Good Practices for medicament manufacturing
RDC.N°53 “Establishes parameters for reporting, identification and qualification of degradation products in synthetic drugs with active substances and semi-synthetic classified as new, generic and the like and other measures”.
RE.N°166 Guide for validation of Analytical and Bio-analytical methods
USP General chapters General tests and assays.

Which analytical lab equipments or instruments are used at Aurigene?

Below is the list of equipments or instruments used

  • HPLCs with wide range of detectors (UV, PDA, CAD, RID and ELSD), Waters and Agilent
  • GC with Headspace and FID, Agilent make
  • GC-MS Agilent make (model: 5975C)
  • LC-MS- AB Sciex QTRAP 4500
  • UPLC-TOF, Waters
  • ICP-MS- Agilent make (model: 7800)
  • Ion chromatography, Metrohm
  • FT-IR, spectrum one, Perkin Elmer make (model: spectrum one)
  • Polarimeter, Jasco (model P2000)
  • Karl-Fisher apparatus, Metrohm
  • Auto titrator, Metrohm
  • Differential scanning calorimeter (DSC), TA (model: TA DSC Q 2000)
  • Thermo gravimetric analyzer (TGA), TA
  • Particle size analyzer, Master sizer 3000
  • Amino acid analyzer, Sykam

Does Aurigene perform analytical method development in order to ensure that the analytical method is 'stability-indicating'?

Stability indicating nature of analytical method will be demonstrated during analytical method development of drug substance related substances and assay method. To demonstrate the stability indicating nature of analytical method, degradation samples shall be generated by stressing the test sample with acid, base, water hydrolysis, oxidative, thermal and photostability study. The degraded sample shall be analyzed and demonstrated the separation of degradation impurities from known impurities and analyte peak. Photostability study shall be carried out as per ICH QIB.


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