Our Service

Introduction:

Analytical development plays a crucial role in process and product development in pharmaceuticals.  It is responsible for ensuring that the product meets the required specifications with the help of appropriate state-of-the-art equipment and validated analytical methods.  Analytical Research and Development Lab provides the necessary tools and expertise to support product and process development activities.

The capabilities of an Analytical Development Lab include various analytical techniques, such as chromatography and spectroscopy.  These techniques are used to analyse the chemical structure, purity, and physical properties of the products.  They also help to identify and quantify impurities and by-products, which can affect the quality and safety of the final product.  Our method development strategy involves the use of proper scientific literature reviews, and careful selection of appropriate analytical techniques to establish the quality and stability of the targeted product.

Furthermore, an Analytical Development Lab provides support for method development, method validation, and transfer of methods to manufacturing facilities.  The activities involve developing robust and reliable analytical methods to ensure consistent product quality and adherence to regulatory requirements.

Overall, the Analytical Development Lab is a critical component of any R&D program, providing valuable insights into the physical and chemical properties of intermediates and APIs.  It plays a significant role in ensuring that drug substances/products are safe, effective, and meet the necessary specifications.

Analytical Services provide accurate, unbiased analysis of research performance by combining high-quality data sources with technical and research metrics expertise.

RECEPS follows strict GMP guidelines in all its analytical testing to ensure that the customers receive reliable and accurate results that meet regulatory and development requirements.  The laboratories are equipped with state-of-the-art analytical instruments that are calibrated and validated according to GMP standards. RECEPS houses highly trained and experienced team of scientists and ensures that all testing are performed in a controlled and consistent manner.  RECEPS maintains detailed records and documentation to demonstrate high level of compliance with GMP guidelines.

Capabilities & Services: The analytical capabilities include but are not limited to:

• Method development, method validation, method verification, and Stress studies as per International guidelines
• Pharmacopoeia monograph evaluation
• Impurity profiling and characterization
• Structural elucidation of unknown compounds
• Physico-chemical properties (log P, pKa, Hygroscopicity, Melting point, etc.)
• Solubility of the drug at different pHs
• Qualification of standards
• Stability testing including Photo stability studies (zone-I, II, III & IV regions)
• Particle size analysis
• Elemental impurity analysis
• Genotoxic impurity analysis
• Nitrosamine impurity analysis
• Polymorphic screening (identification and quantification)
• Thermal properties screening
• Isolation of impurities and Purification of Compounds
• Carry-over of residues studies
• Regulatory support for GMP compliance & DMF / ANDA filings Analytical Instruments: We use advanced analytical instruments to provide accurate and precise results. Our instrument list includes but is not limited to:
• High-performance liquid chromatography (HPLC)
• Headspace Gas chromatography (HSGC)
• Liquid chromatography Mass spectrometry (LC-MS/MS)
• Gas chromatography Mass spectrometry (GC-MS/MS)
• Inductively coupled plasma Mass spectrometry (ICP-MS)
• Powder X-Ray Diffraction (PXRD)
• Laser diffraction particle size analyser (PSD)
• Ion chromatography (IC)
• Differential Scanning Calorimetry (DSC)
• Thermogravimetric analysis (TGA)
• Infrared spectroscopy (IR)
• Ultraviolet-visible spectroscopy (UV-Vis)
• Polarimetry
• Preparative HPLC
• Freeze Dryer / Lyophilizer