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Analytical & Bio-Analytical

Regulatory Services

Analytical

  • Method development for Nonclinical dose formulation assayDRF/AS/001

    This assay develops a method for dose formulation using chromatography to quantify the analyte.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Development of Analytical method to estimate analyte concentration precisely and accurately

    • Relevance

      To quantify analyte of interest in dose formulation
  • Analytical Method ValidationDRF/AS/002

    This assay validates analytical methods for accurate analyte measurement.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Developed Analytical Method will be validated to assess the precision, accuracy and robustness of the method to ensure consistent, reproducible and reliable data.

    • Relevance

      Confirms that the method used for the analysis is reliable, reproducible and fit for its intended purpose
  • Forced Degradation StudiesDRF/AS/003 (Non-GLP)

    This assay identifies degradation products under forced conditions.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Drug product/API degraded product will be identified if exposed to certain extreme conditions.

    • Relevance

      To identify the degradents of drug product/API during extreme exposure to certain conditions
  • Assay, Homogeneity & stability determination of Nonclinical dose formulationDRF/AS/004

    This assay develops a method for dose formulation using chromatography to quantify the analyte.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Analyte concentration verification, homogeneity and stability assessment

    • Relevance

      To ensure concentration, homogeneity and stability of dose formulation
  • Fingerprinting method development for herbal extract/productDRF/AS/005 (Non-GLP)

    This assay develops a fingerprinting method for herbal extracts.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Different chemical constituent and their concentration

    • Relevance

      To identify different chemical constituent/marker compound present in herbal extract/product
  • Chemical/Active Marker Identification and characterization DRF/AS/006 (Non-GLP)

    This assay identifies different chemical constituent present in herbal extract/product using suitable chromatography techniques like HPLC, LCMS, GC.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Different chemical constituent and their concentration will be evaluated.

    • Relevance

      To identify different chemical constituent present in herbal extract/product
  • Marker Assay for herbal substance and productDRF/AS/007 (Non-GLP)

    This assay identifies content of chemical marker present in herbal extract/product using suitable chromatography techniques like HPLC, LCMS, GC.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC

    • End Point

      Different chemical constituent and their concentration will be evaluated.

    • Relevance

      To identify content of chemical marker present in herbal extract/product

Physicochemical

  • Analytical Method ValidationDRF/AD/001

    This assay validates analytical methods for accurate analyte measurement.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC, GC-MS/MS, ICP-MS and IC

    • End Point

      Developed Analytical Method will be validated to assess the precision, accuracy and robustness of the method to ensure consistent, reproducible and reliable data.

    • Relevance

      Physical/Chemical Characterization
  • Melting PointDRF/AD/002

    This assay determines the melting point using melting point apparatus & DSC.

    • Model

      Using Melting Point Apparatus & DSC

    • End Point

      Melting point of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Boiling PointDRF/AD/003

    This assay determines the boiling point using boiling point assembly.

    • Model

      Using Boiling Point Assembly

    • End Point

      Boiling point of Test Product

    • Relevance

      Physical/Chemical Characterization
  • AppearanceDRF/AD/004

    This assay checks the visual observation of test compound using Munsell book.

    • Model

      Using Munsell Book

    • End Point

      Appearance of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Density (for liquid and Formulation Product)DRF/AD/005

    This assay determines the density using pyknometer assembly.

    • Model

      Using Pyknometer Assembly

    • End Point

      Density of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Water SolubilityDRF/AD/006

    This assay determines water solubility using shake flask method.

    • Model

      Using Shake Flask Method

    • End Point

      Determination of analyte concentration in aqueous medium

    • Relevance

      Physical/Chemical Characterization
  • Solvent SolubilityDRF/AD/007

    This assay determines solvent solubility in different solvents using suitable chromatography like HPLC, GC, GC-MS/MS and LC-MS.

    • Model

      Using Suitable chromatography like HPLC, GC, GC-MS/MS and LC-MS

    • End Point

      Solvent solubility of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Partition CoefficientDRF/AD/008

    This assay to determine partition coefficient (log p) using using suitable chromatography like HPLC, GC, GC-MS/MS and LC-MS to partition coefficient of test product.

    • Model

      Using suitable techniques like HPLC, GC, GC-MS/MS and LC-MS

    • End Point

      Partition coefficient of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Flash PointDRF/AD/009

    This assay determines the flash point using flash point apparatus.

    • Model

      Using Flash Point Apparatus

    • End Point

      Flash point of Test Product

    • Relevance

      Physical/Chemical Characterization
  • ViscosityDRF/AD/010

    This assay determines the viscosity using viscosity apparatus and U type glass assembly.

    • Model

      Using Viscosity Apparatus and U type glass assembly

    • End Point

      Viscosity of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Auto Ignition (for Liquid)DRF/AD/011

    This assay determines the auto ignition using auto ignition apparatus.

    • Model

      Using Auto Ignition Apparatus

    • End Point

      Auto ignition point of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Persistent FoamDRF/AD/012

    This assay determines the persistent foam in given time using glass measuring assembly.

    • Model

      Using glass measuring Assembly

    • End Point

      Persistent foam of Test Product

    • Relevance

      Physical/Chemical Characterization
  • SuspensibilityDRF/AD/013

    This assay determines the one or more active ingredient remaining in suspension after a given time using glass apparatus.

    • Model

      Using glass apparatus for Suspensibility

    • End Point

      Suspensibility of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Surface TensionDRF/AD/012

    This assay determines the surface tension using tensiometer apparatus.

    • Model

      Using Tensiometer Apparatus

    • End Point

      Surface tension of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Acidity, Alkalinity & pH RangeDRF/AD/013

    This assay determines the acidity, alkalinity & pH range using pH meter apparatus.

    • Model

      Using pH meter Apparatus

    • End Point

      Acidity, Alkalinity and pH range of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Solution StabilityDRF/AD/014

    This assay determines solution stability using ultra low refrigerator circulating chiller.

    • Model

      Using ultra low refrigerator Circulating Chiller

    • End Point

      Solution stability of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Particle Size DistributionDRF/AD/015

    This assay determines particle size distribution of the test using sieve method.

    • Model

      Using sieve for determination of Particle size distribution

    • End Point

      Particle distribution of Test Product

    • Relevance

      Physical/Chemical Characterization
  • WettabilityDRF/AD/016

    This assay determines wettability of the test product using sieve method.

    • Model

      Using sieve for determination of wettability

    • End Point

      Wettability of Test Product

    • Relevance

      Physical/Chemical Characterization
  • FlowabilityDRF/AD/017

    This assay determines flowability of the test product using sieve method.

    • Model

      Using sieve for determination of flowbility

    • End Point

      Flowability of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Vapor PressureDRF/AD/018

    This assay determines vapour pressure using thermogravimetric analyzer .

    • Model

      Using Thermogravimetric Analyzer

    • End Point

      Vapour Pressure of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Wet & Dry sieveDRF/AD/019

    In this assay a sample of the formulation is dispersed in water the suspension formed is transferred to a sieve and washed using different mesh size sieve (as per guideline requirement) to record the residue as a percentage of the sample weight retention on the stated test sieve.

    • Model

      Using different mesh size sieve (as per guideline requirement)

    • End Point

      Residue as a percentage of the sample weight retention on the stated test sieve

    • Relevance

      Physical/Chemical Characterization
  • Tapped Density and Bulk DensityDRF/AD/020

    This assay determines the tapped density and bulk density using tapped bulk density apparatus.

    • Model

      Using Tapped bulk Density Apparatus

    • End Point

      Tapped and bulk density of Test Product

    • Relevance

      Physical/Chemical Characterization
  • Heavy Metal AnalysisDRF/AD/022

    This assay quantifies the heavy metal present in food product, pharmaceutical and agrochemical pesticide using ICP-MS.

    • Model

      ICP-MS

    • End Point

      Heavy Metal Quantification

    • Relevance

      To quantify the heavy metal present in Food Product, Pharmaceutical and Agrochemical Pesticide
  • Analytical Method Validation for Pesticide ResidueDRF/AD/023

    This assay validates analytical methods for accurate analyte measurement.

    • Model

      Using suitable chromatography techniques like HPLC, LCMS, GC, GC-MS/MS, ICP-MS and IC

    • End Point

      Residue analysis and quantify the residue in different matrix

    • Relevance

      To quantify the residue present in Food Product, Pharmaceutical and Agrochemical product
  • Corrosiveness DRF/AD/024

    This assay determines corrosiveness of test item using 7 different types of metal use (zinc, steel, iron, aluminium, copper etc).

    • Model

      7 different types of metal use (zinc, steel, iron, aluminium, copper etc)

    • End Point

      Corrosivity of test item based on weight loss

    • Relevance

      Physical/Chemical Characterization