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Impurity Profile
- Organic impurities and residual solvents shall be estimated using high sensitive Gas Chromatograph
- Inorganic impurities shall be estimated using Atomic Absorption Spectrophotometer.
- Process impurities are estimated using computer controlled gradient HPLC systems
- Polymorphs are identified and quantified with the aid of XRD
- Melting point by DSC
- Loss of weight by TGA
- Percentage of organic compounds by Elementar
- Isomers are separated and quantified using Chiral HPLC
- Pesticide Residues are estimated with the aid of GC-MS/MS
- Impurities are also identified & quantified using highly sensitive instruments like LC-MS/MS.
Analytical Method Development & Validations
- Validation of pharmacopoeial methods
- Validations for related substance, assay, residual solvents, dissolution profile, trace metals, particle size distribution, microbiological, Bacterial Endotoxins, Air borne particle count & Microbial validation by settling plate method
- HPLC systems with UV florescence detectors, RI detectors and Photo diode array detectors
Particle Size Distribution
- Powder particles (0.5 microns to 900 microns) are characterized and the data is converted to sieve analysis as per ASTM and BS standards
- Liquid Borne particulate Matter (1.5 microns to 150 microns) is measured as per BP & USP
- Air Borne Particles (0.2 microns to 10 microns) with Airflow, Temperature & Humidity
- Specific Surface Area and porosity by BET method
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