Analytical Chemistry

GVK BIO has cGMP & GLP compliant, state-of-the art analytical chemistry solutions laboratory, which is USFDA, EDQM, PMDA and KFDA approved. We offer support in structure elucidation and characterization of small molecules by spectroscopic techniques through fluorine and carbon NMR capability (using 1D, 2D NMR experiments and MS/MS experiments). We also offer cGMP compliant analytical chemistry solutions from pre-clinical to commercial phase III supplies in accordance with current regulatory requirements.

Analytical chemistry solutions are provided for variety of compounds:

Small molecules

Oligosaccharides & carbohydrates

Agrochemicals and pesticides

Drug substances & drug products

Electronic grade chemicals

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Impurity Profiling

  • Isolation and characterisation of unknown impurities from starting materials, intermediates, APIs and formulations utilising the strong skills in preparative HPLC isolation and structure elucidation by NMR using coupling constants, 1D & 2D experiments like NOESY, ROESY, HOESY, HMBC, HSQC, etc., Assignment of absolute configuration by chiral derivatization agents (Mosher’s method).
  • Isolation and structure elucidation of degradants of APIs.
  • Purity determination of raw materials, intermediates and APIs by quantitative NMR (QNMR) and by HPLC assay methods using standard compounds.

Analytical Method Development & Verification Methodology

  • Analytical method development and validation of API (in accordance with the ICH and OECD guidelines to support scale up lab) requirements and other client specifications.
  • Capable of doing short term and long term (accelerated and real time) stability studies of APIs and Intermediates and forced degradation studies.
  • Residual solvent method validation (in accordance with the ICH requirements), complete analytical chemistry solutions for residual solvents estimation, residual metal content and genotoxic impurities.
  • Polymorph/powder characterisation by power XRD technique.

Purification Capabilities

GVK BIO has expertise in isolation, purification and characterisation of new chemical entities and for known compounds. We also offer SFC and mass-based high throughput library purification, purity estimation of NCEs by reverse and normal phase chromatography, determination of enantiomeric excess using variety of chiral columns, high throughput purification and isolation of compounds (chiral and achiral) from milligram to kilogram scale.

List of Analytical Instruments

List of Analytical Instruments

HPLC with PDA, UV, ELSD and RI detectors
UPLC with PDA and ELSD detectors
LC-MS (SQ & TQ) with front end UPLC connected with PDA and ELSD
LC-MS – HPLC Ion trap
LC-MS/MS HRMS (Orbitrap & Q-TOF)
Preparative LC with PDA & ELSD
MS directed Prep. HPLC
NMR (300 MHz, 400 MHz & 500MHz)
Head Space – GCMS or HS-GCMS
GC with Head-space -FID
Melting Point Apparatus
Water purification system
SFC – Analytical
SFC – Preparative
UV Spectrophotometer
Auto titrator
CHNS Analyser
Powder XRD

Analytical Process Flow

asteriskSolubility is checked in ACN, Methanol, THF, DMSO, dilute acids/bases

hashtagFeasibility study is performed based on the probable stability of the compound with respect to buffer

tildePurification is carried out in the Normal phase mode

If the input quantity is more than a gram, the TAT depends on the quantity to be purified

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