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  • Drug Standards (API)

    A reference standard of active pharmaceutical ingredient that has been fully characterized to be used as a standard for manufacturing / finished products / research needs of API.

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards COA
    • - NMR Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - Assay
    • - Resolution of Chiral Compounds
    • - Melting Point
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Water Content by Karl Fischer
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
    • - Optical Rotation
  • API Intermediates / Related Compounds

    An intermediate which is a regulatory starting material manufactured as per the cGMP manufacturing process – which meets all the requirements of regulatory bodies (quality & regulatory documents) as well as supporting the customers throughout the lifecycle of API manufacturing with all documents/process impurities etc.

    Regulatory Aspect:
    Documentation for KSM

    • - ROS
    • - Technology Transfer Doc
    • - RM’s for KSM (source, specifications, COA, MOA, MSDS etc)
    • - INP Test Methods, Specifications or Release Criteria)(INP for drying, milling etc)
    • - KSM (Specifications, COA, MOA, MSDS, Stability Data etc)
    • - Flow Charts
    • - Residual Solvents
    • - Master BPR
    • - VDQ
    • - TSE / BSC Certificate
    • - Manufacturing Site Declaration Forms
    • - Quality Commitment
    • - Audit Acceptance
    • - GMP Declaration
    • - Packing/Storage/Pack Size Declaration
  • Polymorph Standards / Pharmaceutical Solids

    Polymorphism is often characterized as the ability of a drug substance to exist as two or more crystalline phases that have different arrangements and/or conformations of the molecules in the crystal lattice. A reference standard of that has been fully characterized to be used as a Polymorph standards for research needs. (Picture of XRD or TG or IR)

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards COA
    • - PXRD Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - NMR Analysis
    • - Differential Scanning Calorimetry (DSC)
    • - Thermogravimetric Analysis (TGA)
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
  • Drug Impurities / Related Compounds

    Synthetic products which has been identified/fully characterized to be used as referecence standard as per the regulatory requirements to be used as standards for the R&D, Production of API’s or finished products.

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards
    • - NMR Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - Resolution of Chiral Compounds
    • - Melting Point
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Water Content by Karl Fischer
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
    • - Optical Rotation
  • Drug Metabolites / Drug Glucuronides

    Chemical transformations of Active pharma ingredients compounds form new metabolic products with distinct spectroscopic signatures.

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards
    • - NMR Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - Resolution of Chiral Compounds
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
  • Drug Labeled Products

    The stable deuterium labeled molecule (drug or drug metabolite) are the best internal standard for bio analysis study. We provide labeled products of high quality with complete interpretation data.

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards
    • - NMR Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - Resolution of Chiral Compounds
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
  • Genotoxic Impurities

    PGIs are reactive compounds that can induce genetic mutations by reacting with DNA. If a PGI is present in an active pharmaceutical ingredient (API), it can potentially cause cancer in the patient.

    Regulatory Aspect:
    Documentation

    • - Certification of Analytical Reference Standards
    • - NMR Analysis
    • - Mass Spectrometry Analysis
    • - IR Analysis
    • - Resolution of Chiral Compounds
    • - HPLC-DAD, HPLC-PDA, HPLC/MS/MS
    • - Residual Solvent Content by 1H-NMR or GC-Headspace
  • Drug Impurities / Related compounds

    A reference standard of an impurity in the active compound or intermediate that has been fully characterized to be used as a standard.