chromatography services

At Dextrose Technologies Pvt. Ltd., we provide Documentation & Regulatory Support to deliver inspection-ready analytical outputs for R&D and QC programs. Our focus is SOP-driven execution, clean data presentation, and structured reporting that speeds up internal QA review and client submissions. We support chromatography and mass spectrometry workflows (HPLC/RP-HPLC, GC-FID, HS-GCMS, GCMS, LCMS—scope dependent) with consistent documentation and clear interpretation. SOP-Driven Testing Testing is performed using controlled workflows with documented sample handling, instrument conditions, and batch execution notes for traceability. Regulatory-Style Analytical Reports We provide structured reports with sample identifiers, method conditions, chromatograms/spectra (as applicable), results tables, calculation basis, and clear conclusions—formatted for review and submission support. Partial Method Validation Support We support partial validation for defined scope parameters such as accuracy, precision, and linearity, with summary tables and acceptance criteria where agreed. Data Review & Interpretation We review chromatograms/spectra to highlight key findings, trends, and anomalies, and provide practical interpretation notes aligned to your decision goal. Client-Specific Reporting Formats If you have internal templates or required sections, we can align reporting to your preferred format for smoother approvals and submissions. Outcome you can expect * Audit-friendly documentation with clear traceability * Faster client submissions supported by structured reporting Get started Share your method, analytes, sample count, and preferred report template. We’ll propose the best documentation package for your workflow.

At Dextrose Technologies Pvt. Ltd., we provide Formulation & Manufacturing Support to strengthen process control and improve formulation robustness. Our chromatography-led testing helps teams monitor in-process quality, compare batches, identify variability early, and support smoother scale-up and technology transfer with clear, trend-ready reporting. Dissolution Sample Analysis (HPLC) We analyze dissolution samples by HPLC to quantify release profiles across timepoints, supporting formulation optimization and batch-to-batch comparison. In-Process Sample Testing We test in-process samples to support process control—helping teams catch deviations early and maintain consistent quality during manufacturing. Excipient Compatibility Studies We evaluate compatibility between APIs and excipients to flag potential interactions or instability risks and guide formulation decisions. Batch Comparison and Trend Analysis We generate structured data for batch comparison and trending (assay, impurities, key markers), enabling faster root-cause analysis and more confident release decisions. Scale-Up and Tech Transfer Analytical Support We support scale-up and method transfer activities by aligning analytical conditions, confirming method performance, and packaging results into clean, review-ready reports. Outcome you can expect * Stronger process consistency and reduced variability * Faster troubleshooting with trend-ready outputs * Smoother scale-up and technology transfer Get started Share your product type, sampling points, analytes, expected ranges, and timeline. We’ll propose an efficient testing plan and reporting format.

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.

At Dextrose Technologies Pvt. Ltd., we support Stability & Shelf-Life Studies to help you justify shelf-life, understand degradation pathways, and generate clear, trend-ready data for internal QA and development decisions. Our services cover stability-indicating method development, long-term and accelerated timepoint analysis, degradation profiling, and packaging interaction screening using chromatography and mass spectrometry. Stability-Indicating Method Development We develop methods that can clearly separate the main compound from degradation products, enabling accurate stability assessment and cleaner decision-making. Long-Term & Accelerated Stability Sample Analysis We analyze stability samples across planned timepoints for long-term and accelerated studies, reporting assay/impurity trends in structured formats. Degradation Product Profiling (HPLC / LCMS) We profile degradation products using HPLC and support identification/confirmation with LCMS where required (scope-dependent), helping you understand what is forming and when. Volatile Degradation Monitoring (HS-GCMS) For volatile components or residual solvents, we monitor changes over time using Headspace GCMS, enabling sensitive tracking with reduced matrix interference. Packaging Interaction Screening Screening studies to evaluate potential packaging-contact interactions that may impact product quality, supporting packaging selection and early risk assessment. Trend Analysis Across Stability Time Points We provide trend-ready tables and summaries across timepoints to support faster reviews and clearer shelf-life justification. Outcome you can expect * Strong stability-indicating methods and timepoint-ready workflows * Clear degradation visibility (non-volatile and volatile) * Structured trend data to support shelf-life justification Get started Share your product type, analyte(s), planned timepoints, storage conditions, and reporting expectations. We’ll recommend the most efficient stability workflow.

At Dextrose Technologies Pvt. Ltd., we provide Quality Control (QC) Testing to support batch release, routine compliance, and in-process control. Our chromatography-based QC services deliver consistent, calibration-based results with clear documentation and regulatory-aligned reporting. We help you reduce batch risk, maintain trendable quality metrics, and move faster through internal QA review. Assay Testing (HPLC / RP-HPLC) Accurate content estimation for APIs, intermediates, and formulations using validated/optimized chromatographic methods and standards-based quantification. Related Substances / Impurity Profiling Separation and monitoring of related substances and impurities to support batch comparison, process control, and product quality assessment. Content Uniformity Testing Testing to evaluate dosage consistency across units with structured reporting for easy review and trending. Residual Solvent Analysis (GC-FID / HS-GCMS) Residual solvent quantification using GC-FID or Headspace GCMS, based on target solvent list, matrix, and required limits (ICH Q3C-oriented where applicable). Volatile Impurity Testing Volatile impurity profiling for troubleshooting and routine QC checks using GC techniques suited to your sample type. System Suitability & Routine QC Analysis System suitability testing (SST) and routine batch analysis with documented acceptance checks and clean reporting. Cleaning Validation Sample Analysis HPLC/GC-based analysis of swab/rinse samples for trace residues to support cleaning validation programs (scope-dependent). Outcome you can expect * Batch release readiness with consistent analytical outputs * Ongoing quality monitoring with trend-ready results * Clear, regulatory-aligned reporting for internal QA and client documentation Get started Share your product type, analyte list, specifications/limits, and sample count. We’ll recommend the most efficient QC

At Dextrose Technologies Pvt. Ltd., our R&D Analytical Support helps teams move faster from idea to data with the right analytical strategy and clear, decision-ready reporting. We support method development, compound understanding, reaction tracking, and early impurity/degradation visibility—so you can shorten development cycles and reduce trial-and-error. HPLC / RP-HPLC Method Development & Optimization We develop and optimize chromatography methods (column, mobile phase, gradient, flow, detection) to achieve strong resolution, repeatability, and robustness for your sample type. Assay Method Development for APIs & Formulations Calibration-based assay methods for APIs, intermediates, and formulations with clear reporting units and suitability checks as applicable. LCMS-Based Molecular Weight Confirmation Mass confirmation for non-volatile compounds to support identity verification, batch comparison, and early-stage characterization. Structural Elucidation (Small Molecules) Support for small-molecule structural understanding using MS-based interpretation (scope-dependent), with clear notes and next-step recommendations when needed. Impurity and Degradation Product Identification We profile impurities and degradation products to provide early visibility into risks and to guide method refinement and process decisions. Reaction Monitoring (HPLC / TLC) Fast reaction tracking to support endpoint decisions and process optimization, reported in a structured and easy-to-interpret format. Peptide & Small Molecule LCMS Analysis LCMS analysis for peptides and small molecules (scope-dependent), supporting mass confirmation and profiling. Exploratory Bioanalytical LCMS (Non-GLP) Exploratory analysis for R&D (non-GLP) with workflows tailored to matrix complexity and required sensitivity. Outcome you can expect * Robust analytical methods suitable for R&D progression * Early impurity and degradation visibility * Faster development cycles with clearer decisions Get started Share your compound class, sample matrix, development stage, and goal (method development, impurity ID, reaction monitoring). We’ll propose the fastest, most reliable plan.

At Dextrose Technologies Pvt. Ltd., we provide method support and documentation to help teams generate reliable analytical results with clean, audit-ready reporting. We support analytical method transfer, partial method validation, system suitability checks, and stability sample analysis across chromatography platforms (HPLC/RP-HPLC, GC-FID, GCMS, HS-GCMS, LCMS—scope dependent). Our focus is on clear documentation, traceability, and decision-ready outputs. Analytical Method Transfer Support We help implement and verify your existing method by aligning instrument settings, sample prep, standards, and acceptance criteria. This supports consistent results when transitioning methods between teams, sites, or projects. Partial Method Validation (Accuracy, Precision, Linearity) We perform partial validation studies to demonstrate method performance for defined scopes, typically covering: * Accuracy (recovery) * Precision (repeatability / intermediate precision as applicable) * Linearity (calibration range and fit) Additional parameters can be added based on need. System Suitability Testing (SST) We run system suitability checks prior to sample batches to confirm method readiness and instrument performance, and document results against predefined criteria. Stability Sample Analysis We analyze stability samples across timepoints and provide trend-ready results to support R&D and product decisions. Regulatory-Style Test Reports We deliver structured reports with method details, sample identifiers, results tables, chromatograms, calculations basis, and clear conclusions—formatted for internal QA review and client documentation needs. Deliverables * Transfer/validation plan summary (scope + acceptance criteria) * Raw data summary + results tables + calculations basis * Chromatograms/spectra and SST outputs (as applicable) * Final report in a clean, regulatory-style format Get started Share the method, analyte list, matrix, target limits, and required parameters (accuracy/precision/linearity). We’ll propose a practical study plan and documentation package.

At Dextrose Technologies Pvt. Ltd., we offer Thin Layer Chromatography (TLC) services for rapid, cost-effective qualitative analysis of compounds and mixtures. TLC is ideal for reaction monitoring, quick purity checks, and herbal/phytochemical screening before moving to advanced techniques like HPLC, LCMS, or GCMS. We deliver clear plate documentation and interpretation to support fast decisions in R&D and QC workflows. Qualitative Compound Identification We support qualitative identification using Rf values and spot visualization under appropriate detection conditions, enabling quick comparison against references or known samples (when provided). Reaction Monitoring We monitor chemical reactions and process steps by tracking the appearance/disappearance of spots over time, helping you decide end-point completion and optimize conditions. Purity Checks We perform quick purity checks to detect major impurities or multiple components in a sample, supporting batch comparison and early-stage QC screening. Herbal and Phytochemical Screening We use TLC for preliminary screening of herbal extracts and phytochemical fractions to guide fractionation, method development, or targeted analysis. Deliverables * TLC plate images/documentation * Rf values and observation summary * Interpretation notes aligned to your objective * Optional recommendation for confirmatory HPLC/LCMS/GCMS when needed Get started Share your sample type, solvent system preference (if any), and objective (ID/reaction monitoring/purity/herbal screening). We’ll recommend an efficient TLC workflow.

At Dextrose Technologies Pvt. Ltd., we offer Headspace GCMS (HS-GCMS) testing for accurate analysis of volatile compounds with reduced matrix interference. By sampling the vapor phase above the sample, HS-GCMS improves repeatability for residual solvent testing, volatile impurity profiling, and screening studies. Our workflows are designed for R&D and QC support with clean documentation and decision-ready reporting. Residual Solvent Analysis (ICH Q3C-Oriented) We support ICH Q3C-oriented residual solvent analysis by targeting relevant solvents, using calibration-based quantification (as applicable), and reporting results in clear units based on your limits and sample type. Volatile Impurity Profiling We profile unknown or suspected volatile impurities to support troubleshooting, process optimization, and batch comparison, with MS-based confirmation where possible. Packaging Interaction Studies (Screening) We provide screening studies to evaluate potential volatile compounds that may arise from packaging/contact materials interactions (scope-dependent), useful for early risk assessment and comparison between packaging options. Stability Study Support for Volatile Components We support stability programs by tracking volatile components across timepoints, enabling trend analysis and comparison between storage conditions or formulations. Deliverables * Headspace GCMS chromatograms + peak tables * Mass spectra and identification summary (where applicable) * Quantitative results (when standards/targets and reporting limits are defined) * Method notes and interpretation aligned to your objective * Optional recommendations for follow-up confirmation or expanded screening Get started Share your sample type, target solvent list (if known), required limits/units, and whether you need ID only or ID + quantification. We’ll propose the right HS-GCMS workflow.

At Dextrose Technologies Pvt. Ltd., we provide Gas Chromatography–Mass Spectrometry (GCMS / GC–MS) services for identification and profiling of volatile and semi-volatile compounds in complex samples. GCMS combines strong chromatographic separation with mass spectral confirmation to support unknown peak identification, impurity profiling, and screening studies for R&D and industrial applications. Volatile and Semi-Volatile Compound Identification We identify volatile and semi-volatile compounds using GC separation and MS-based spectral interpretation, supporting troubleshooting, screening, and confirmation workflows. Impurity Profiling We detect and profile impurities and unknown peaks to support batch comparison, contamination investigations, and process optimization. Extractables and Leachables (Screening) We offer screening-level E&L studies to evaluate potential extractable/leachable compounds from packaging, plastics, tubing, or contact materials (scope-dependent, non-regulatory screening unless specified). Flavor and Fragrance Component Analysis We can support fragrance/flavor component analysis only when identification is feasible within our available spectral resources and project scope. (If a dedicated fragrance library is required, we will clarify feasibility upfront.) Environmental and Industrial Sample Analysis We analyze VOC/SVOC profiles in environmental and industrial samples (water/soil/air extracts, process samples, materials) for screening, comparison, and investigation needs. Deliverables * Chromatograms + peak tables * Mass spectra and ID summary for identified peaks (where applicable) * Impurity/profile interpretation notes * Quantification support when standards and reporting limits are defined Get started Share your sample type, target analytes (if known), expected concentration range, and whether you need identification only or identification + quantification.

At Dextrose Technologies Pvt. Ltd., we provide Gas Chromatography with Flame Ionization Detection (GC-FID) for accurate, repeatable quantification of volatile organic compounds (VOCs) and residual solvents. GC-FID is ideal for routine QC and batch comparisons where calibration-based quantification, stable detector response, and clear peak reporting are required. Residual Solvent Analysis We quantify residual solvents in raw materials, intermediates, and finished products using method conditions aligned to your target solvents and required limits. Volatile Organic Compound (VOC) Analysis We perform VOC quantification for industrial, R&D, and quality investigations, generating clean chromatograms and concentration outputs for decision-making. Alcohol and Solvent Quantification We quantify common alcohols and solvents (as per scope) with suitable calibration and reporting formats (ppm, %, mg/L—based on requirement). PURITY Assessment of Volatile Compounds We support purity assessment by reporting chromatographic peak profiles, area%, and impurity trends for volatile samples and solvent blends. Deliverables * Chromatograms + peak table (RT/area/area%) * Quantitative results with calibration approach (as applicable) * Method notes and observation summary * Optional: recommendation for confirmatory GCMS when identity confirmation is required Get started Share your sample type, target solvent/VOC list, and required reporting units. We’ll recommend the best GC-FID workflow and turnaround plan.

At Dextrose Technologies Pvt. Ltd., we provide Liquid Chromatography–Mass Spectrometry (LCMS / LC–MS/MS) services for high-confidence molecular weight confirmation, compound identification, and impurity/degradation profiling. LCMS is ideal for non-volatile and thermally sensitive compounds where mass-based confirmation is required. We support R&D and exploratory projects with clear reporting and practical interpretation. Molecular Weight Confirmation We confirm molecular mass and assess molecular ions/adducts (as applicable) to support identity verification and batch comparison. Compound Identification and Characterization We support compound identification using LC separation plus MS/MS-based fragmentation (scope-dependent), enabling stronger confidence than chromatography alone. Impurity Identification and Profiling We detect and profile impurities in complex mixtures and help prioritize unknown peaks for follow-up characterization. Degradation Product Identification We support stability investigations by detecting and identifying degradation products formed under storage or stress conditions (as applicable to your study plan). Metabolite Identification For exploratory studies, we can support metabolite detection/identification workflows based on the sample type and objective (project-dependent). Bioanalytical Sample Analysis (non-GLP exploratory) We handle exploratory bioanalytical analysis for R&D (non-GLP), with method approach finalized based on matrix complexity and target sensitivity. Peptide and Small Molecule Analysis We support peptide and small molecule analysis (project scope dependent), including mass confirmation and profiling. MS Data Interpretation and Reporting We provide structured reports with chromatograms, key ions, observed masses, and interpretation notes—so teams can act quickly. Deliverables * Chromatograms + peak tables * Observed m/z values and spectra/MSMS details (where applicable) * Impurity/degradation profiling summary * Quantitative results (if calibration standards are provided/defined) * Clear conclusions and next-step recommendations Get started Share your sample type, expected mass range, target analytes (if known), and objective (ID/impurities/degradation). We’ll recommend the most reliable LCMS approach.