State-of-the-art analytical chemistry for impurity profiling and stability studies
The analytical chemistry department is well-equipped with state-of-the-art instrumentation and experienced chemists for performing for 5 batch analysis impurity profiling and physico-chemical parameters and chemical characterization for agrochemicals, pharmaceuticals, nutraceuticals and other industries. We can analyze all types of molecules as per relevant international/national guidelines such as OECD, OPPTS, EPA, EU, ASTM, EEC, FDA, IP, USP, ICH, ABNT, NBR, ISO, SANCO, SANTE, REACH, ECHA, APVMA,BIS, FAO and WHO. From a regulatory perspective, scientific insight and experimental rigor to GLP standards are essential to generate first-hand experimental data using appropriate methods with high levels of accuracy and reproducibility.
E-Fate Studies
- Ready and Inherent Biodegradability
- Soil leaching
- Photolytic Degradation
Key Pointers
- Method development and method validation
- For all regulatory submissions, validation of an analytical method is essential to ensure the accuracy, precision, specificity, LOD, LOQ, linearity & range, and robustness of data being collected
- Chemical characterization (ATR – Analytical test report)
- Impurity profiling and 5 batch analysis
- While generating the product specifications for global regulatory submissions, a 5-batch analysis is essential for the registration of agrochemicals that is required to prove their chemical equivalence
- Physical and chemical properties of technical and formulation grade
- Storage stability
- Accelerated storage studies
- Cold temperature storage stabilities
- Long-term storage stability & corrosion characteristics studies (1-2 Years)
- Stability at shelf life (storage stability)- one year/2-year/cold temp
- Storage stability with metal and metal ions at normal and elevated temperatures
- Dose formulation analysis (For toxicity studies)
- Elemental analysis
- Identification and quantification of elemental/metal composition in diversified sample types
- Biological matrices like tissues, blood/plasma, etc.
- Water
- Leachable and extractable analysis for medical devices
