Description

At Dextrose Technologies Pvt. Ltd., we provide impurity, residual, and risk-based analytical studies to help teams mitigate regulatory risk and build a clear control strategy. Our work supports ICH-oriented impurity profiling and residual solvent analysis, unknown impurity identification using MS tools, and screening studies that strengthen development decisions and documentation. ICH Q3A/Q3B-Oriented Impurity Profiling We support impurity and related substances profiling aligned to ICH Q3A/Q3B intent, using HPLC/RP-HPLC (and LCMS where required) to generate clear impurity visibility and trend-ready outputs. ICH Q3C-Oriented Residual Solvent Analysis We perform residual solvent testing using GC-FID or Headspace GCMS with an ICH Q3C-oriented approach, reporting results in clear units and against the target solvent list/limits you define. Unknown Impurity Identification (LCMS / GCMS) We investigate unknown peaks using LCMS (non-volatile/polar) and GCMS (volatile/semi-volatile) to support impurity identification, root-cause analysis, and next-step planning. Extractables & Leachables Screening (GCMS) We offer screening-level extractables/leachables (E&L) studies by GCMS to evaluate potential risks from packaging or contact materials (scope-dependent, intended for early risk assessment unless a specific standard is agreed). Cross-contamination Risk Assessment Support We provide analytical inputs that support cross-contamination risk assessments—such as targeted carryover checks, comparative profiling, and data packaging for internal QA review (scope-dependent). Outcome you can expect * Reduced regulatory risk through early impurity/residual visibility * Clear impurity control strategy supported by structured analytical data Get started Share your product type, target analytes/solvents, reporting limits, and whether you need profiling only or profiling + unknown ID. We’ll recommend the most efficient plan.