Equipments and Techniques

Chromatography Equipments

• HPLC instruments coupled with UV, PDA, ELSD, CAD and RI detectors with Empower 3 software

• GC instruments FID, TCD, ECD detectors with Empower 3 software

• UPLC instruments

• Ion Chromatography

Advanced Characterization Techniques

• Waters Absolute LCMS TQXS

• Agilent LC MS with triple quad mass detectors

• Agilent GC MS with triple quad mass detectors

• UV-Visible spectrophotometer

• FT- IR

• Bruker 600 MHz NMR spectroscopy

• ICPMS Agilent 7800

Solid State Characterization Techniques

• DSC,TGA and DVS instruments

• Particle size analyzer: Malvern Master sizer 3000

• Headspace Coulometer, Karl Fischer Analyzer

• XRD Bruker D8 Advanced

• Hot stage Microscopy

• Surface Area Analyzer

• Capillary Zone electrophoresis (CZE)

Preparative Chromatography

• Preparative Scale HPLC (mg - gram Scale)

• Flash Chromatography equipped with ELSD

• Gel Permeation Chromatography

• Ion Exchange Chromatography

• Bench-Top Lyophilizer

Early Phase

For early-phase projects, we develop analytical methods in parallel with process development. Critical quality attributes (CQAs) such as assay, related substances, and residual solvents are verified through standard method validation, assessing LOD, LOQ, linearity, precision, specificity, accuracy, robustness, and stability. Additionally, fit-for-purpose methods are established for raw material testing, in-process controls, and intermediate analysis. After equipment mapping at the manufacturing facility, residue methods are developed and validated. To support analysis and method transfers, we generate and qualify the necessary reference standards.Typical characterization of the reference standard includes

• Characterization with appropriate spectroscopic techniques, Mass spectrometry, NMR and FT-IR

• Testing for its impurities (related substances or chromatographic purity) as per the pre-defined test procedure

• Water by KF or loss on drying

• Other parameters such as sulphated ash or residue on ignition (ROI) or residual solvents

• Determination of the potency of the reference standard

• The polymorphic characteristics of the material will be analyzed if it is a specific polymorph

Late Phase

At CRAMSN Research Park, we perform method validation as per internal SOPs and ICH guidelines, ensuring compliance across all phases of development. Key validation parameters include LOD, LOQ, linearity, precision, accuracy, robustness, and stability studies.

Phase-Specific Analytical Activities :

• RSMs: Analytical methods are developed and validated for Regulatory Starting Materials (RSMs), focusing on related substances, assay, residual solvents, and general tests (appearance, identification, water content, etc.).

• Intermediates: Methods undergo validation during process validation, followed by formal method transfer to quality control.

• Final API: Analytical methods are validated before manufacturing batches.

Additional Analytical Studies :

• Forced Degradation: Stability is assessed under acid, base, peroxide, thermal, and photolytic conditions.

• Pharmacopeial Verification: Identity tests (¹H NMR, ¹³C NMR, FT-IR, PXRD, DSC, KF) confirm compound authenticity.

• Residue Method Development: Validated post-equipment mapping at the manufacturing site.

• Impurity Analysis: Sensitive methods for Potential Genotoxic Impurities (PGI), nitrosamines, and elemental impurities.

Reference Standard Characterization :

• Spectroscopic analysis (MS, NMR, FT-IR)

• Impurity profiling (related substances, chromatographic purity)

• Moisture content (KF, loss on drying)

• Residue analysis (ROI, sulfated ash)

• Potency determination and polymorph analysis (if applicable)

This rigorous analytical framework ensures high-quality, regulatory-compliant process development.