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For more than two decades, we are providing comprehensive pharmaceutical analytical services to clients across the industry. Our services include method verification, development and validation, impurity identification and characterizations and isolation of impurities by preparative scale purification, reverse phase/normal phase, ion-exchange or gel filtration chromatographic techniques. Our analytical team works in close collaboration with our process chemistry team to ensure that every method suits the process requirements for raw materials, APIs and formulations.

Our pharmaceutical analytical services research team is well versed with current regulatory requirements to support you from early research to market.

We offer method verification, development and validation for excipients, raw materials, APIs and drug products including high potent compounds, steroids, carbohydrates and synthetic peptides.

Our Custom Services also Include:

 
  • Purity of Enantiomers
  • Identification of related substances and assay
  • 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 instruments

  • HPLC with VWD, DAD, ELSD, CAD and RID
  • UPLC with VWD and DAD
  • LC-MS/MS triple quard
  • LCMS-TOF
  • GC and GC-HS
  • GC-MS (EI/CI MSD)
  • Ion Chromatography
  • ICP-OES
  • AB Sciex QTRAP 4500 Mass Spec
  • NMR 400 MHz
  • Amino Acid Analyzer
  • Dissolution: USP type I and type II, small volume dissolutions using USP Type II apparatus and in-vitro diffusion cell apparatus
  • UV-VIS Spectrophotometer
  • FT-IR Spectrophotometer
  • Polarimeter
  • Auto-titrator and KF Apparatus
  • Differential Scanning Calorimeter
  • Thermo Gravimetric Analyser
  • Particle Size Analyser (Malvern)
  • Nano-particle Size Analyser (zeta sizer)

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

FAQ

  • 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)

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

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.

Below is the list of equipmen/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

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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