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Product Chemistry Services

Physicochemical Characterization

Physicochemical testing is an integral requirement of Agrochemical Registration throughout the World. Our Product Chemistry Laboratory Offers full gamut of Physical & Chemical Characterization studies for TGAI and Formulated products. We also provide necessary support for worldwide Registration Submission.

Analytical Chemistry Support

These includes Analytical Method Development and Validation, Method Optimization, Partial Validation and Method Transfer using modern and up to Date equipments. The Validation of Analytical method demonstrates the scientific accuracy of the measurement. Any In-House developed method requires validation for using the same in Characterization of any Chemical entity, intended for any Regulatory submission. Method validation is generally not required for a Standard method viz., CIPAC, AOAC, BIS etc. But, any modification in the same requires a Partial Validation. For Analytical method validation we follow all international Guidelines viz., OPPTS, CIPAC, SANCO, APVMA as well as internal SOPs and Protocols. Our Analytical Chemistry group ensures the Repeatability, Robustness, Accuracy and Transferability of the validated Analytical method covering the parameters like

  • Specificity
  • Accuracy
  • Precision
  • Linearity / Range
  • Robustness
  • LOD &
  • LOQ

Our Laboratory also participates in Proficiency Testing (PT) and Inter Laboratory Comparison (ILC) to establish and demonstrate the Reliability & Robustness of the Analytical Method/Procedure.

Stability Testing

The Storage stability of a Product (TGAI & Formulation) need to be studied under a variety of specific storage conditions of varied Temperature & Humidity. Our Product Chemistry Laboratory undertakes Stability Study at 54±2℃, 0±2℃, as well as different storage conditions defined by different Regulatory authorities all over the world. We also conduct specific Storage Stability studies under the following conditions up to 30 days

  • 25±2℃ and 50±3 RH
  • 30±2℃ and 50±3 RH
  • 50±2℃ and 80±3 RH
  • 54±2℃ and 65±3 RH
  • 54±2℃ and 84±3 RH

In addition to this we also conduct 30 month Storage Stability study at 3 different locations (different Climatic Condition)

Chemical Characterization & Chemical Equivalence

We offer full Chemical Characterization of a TGAI, API and Formulated Product, to determine the Chemical Composition including Active ingredient, Moisture, Inorganic component (Acetone Insoluble / Sulphated Ash) etc. The Chemical Equivalence is also been established for a Pure / TGAI using different Chromatographic & Spectroscopic techniques like

  • Co-Chromatography (RT Matching with Reference Item)
  • IR Spectra Analysis & Matching with Reference Item
  • Mass Spectra Analysis & Matching with Reference Item
  • Determination of UV Absorption (?max)
  • Proton NMR Spectra Analysis & Matching with Reference Standard

Five Batch Analysis

Chemical Composition / Impurity profile is very important to establish the Nature & Quantity of unwanted impurities which could be Toxicologically Significant. Five Batch analysis is the first step to establish the composition of a TGAI of a Manufacturer. This study is very useful in defining the specification of a Product/Pesticide w.r.t. active ingredient (a.i.) (minimum content) and the impurity levels (maximum content). This Study is necessary, for a new product or the same product is synthesized following a different route. This Service includes

  • Scanning of TGAI by GC-MS/LC-MS/GC-MS-MS/LC-MS-MS/LC-DAD-3D Analysis
  • Identification & Characterization of all other components by MS-MS-MSn and other Spectroscopic techniques
  • Method Development & Validation for Impurity Analysis and Alternate Method of Analysis of Active following OPPTS/SANCO/CIPAC/APVMA etc
  • Preparation/Procurement of Reference Standards of all significant impurities (>0.06%)
  • Quantification of all significant impurities, moistures, inorganic part, residual solvent, organic insoluble etc
  • Establishing overall Recovery/Mass Balance up to 100±2%

List of Product Chemistry Studies

  • Chemical Characterization (Analysis of Active Ingredient)
  • Determination of Colour Odour & Physical State
  • Determination of Density/Relative density/Specific gravity
  • Determination of Acidity/Alkalinity/ pH
  • Determination of Boiling point/Melting Range
  • Determination of Dissociation constant
  • Determination of Corrosion Characteristics
  • Determination of Flash Point
  • Method Development & Validation
  • Five Representative Batch Analysis
  • Determination of Miscibility
  • Determination of Moisture Content
  • Spectral Analysis (UV/VIS,IR & Mass)
  • Determination of Oxidation/Reduction
  • Determination of Oxidizing Properties(Solid)
  • Determination of Partition Co-efficient (Shake Flask Method)
  • Determination of Flammability
  • Determination of Self Life (Storage stability & Corrosion Characteristics)
  • Determination of Solvent Solubility
  • Determination of water Solubility
  • Formulation storage stability
  • Accelerated storage studies for provisional shelf-life assessment
  • Long-term storage studies for full shelf-life requirements
  • Storage Stability (Stability at 54±2℃ & 0±2℃)
  • Determination of Vapour Pressure [Gas Saturation]
  • Determination of Surface Tension
  • Determination of Viscosity
  • Determination of Wettability
  • Determination of Wet Sieve test
  • Determination of Dispersibility / Dispersion Stability
  • Determination of Spontaneity of Dispersion
  • Determination of Flowability
  • Determination of particle Size Distribution
  • Determination of Attrition Resistance
  • Determination of Persistent Foaming
  • Determination of Pourability
  • Determination of Dilution Stability
  • Determination of Emulsion Stability - OTHERS
  • 
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T-1, QK-17 (Part) WBIIDC, Phase III,
Kalyani, Nadia, West Bengal 741 235 ,INDIA

+91 33 2582-4472