Analytical Research Services - Indoco Analytical Solutions

DMF Related Activities

We are experienced in designing and executing the carry-over studies required for filing API and drug products. These include carry-over of solvents, impurities, reagents, catalysts, and intermediates to the subsequent stage of API or final drug product. These studies are carried out using chromatographic and spectroscopic techniques up to the trace level.

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Colour Index Study

The following tests can be performed at our laboratory using a color spectrophotometer: Measure drug substance and drug product colors Measure paints and textile color shades Measure transmittance value of cosmetics Measure chemical reflectance of chemical compounds Measure liquid transmittance of chemicals

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Particle Size Distribution Studies

Malvern-Mastersizer 3000 PSA Analyzer Salient Features: The particle size can affect the rate at which a substance will dissolve. Determination of particle size ranges from 0.1um to 35um and can be best possible by Malvern Master-size 3000   Class-leading particle sizing performance that generates the robust, reliable data you need while making the best use

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Thermal Analysis

Thermal Analyzer-DSC 3+ Mettler-Todelo Salient Features: Determining structural-phase transition, melting point, heat of fusion, percent of crystallinity, crystallization kinetics and phase transitions, oxidative stability, thermodynamical analysis of biomolecules   DSC enables the measurements of the transition, such as the glass transition, melting, and crystallization. Furthermore, the chemical reaction such as thermal curing, heat history, specific

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Partition Coefficient and Dissociation Constant

A) Partition Coefficient Determination of Partition Coefficient as per OED guidelines Determination of Dissociation Constant as per OECD guidelines Determination of pKa B) Determination of pKa by Technique Potentiometric method Spectrophotometric method Liqid-liquid partition method

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Physicochemical Studies

We provide physical and chemical testing for the chemical, pharmaceutical, and cosmetics industries to validate various parameters and ensure adherence to globally recognized standards and protocols. This testing includes solubility (aqueous, buffer, solvent), partition coefficient (octanol/water), dissociation constant (pKa), pH of solutions, and hygroscopicity.

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Forced Degradation Studies

IAS provides forced degradation/stress studies involving drug substance exposure to heat, humidity, and light for solid-state studies. In contrast, stress studies are performed using acid-based hydrolysis and oxidation at various temperatures in solution form. The laboratory is equipped with a photostability chamber that provides photostability testing of drug substances and drug products, as per ICH

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Analytical Method Development, Validation, and Transfer

Our highly experienced and skilled scientists have acquired years of experience in method development and validation by working across many types of products, methods, and analytical technologies. AS provides analytical method validation according to the range of regulatory agencies for compendial and non-compendial methods across various analytical technologies such as HPLC, GC, GCHS, LCMS, GCMS,

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Genotoxic Evaluation and Studies

Pharma companies are now required to assess the potential genotoxic impurities (GTI) in their API and drug products, which must comply with regulations that limit patient exposure to certain impurities to as low as 1.5 µg/day. IAS assists the customer in identifying the potential GTI in the process and developing and validating a sensitive analytical

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Qualification and Characterisation of Standards

IAS offers a complete standard management program that includes standard reference development, qualification, and characterization for raw materials, intermediates, impurities, and active pharmaceutical ingredients. Qualification is carried out using the chromatographic, spectroscopic, or titrimetric technique for the establishment of potency, whereas, for characterization, the identity of the chemical is established by using multiple orthogonal techniques

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