Chennai
08048047702
+919686928701
Chromatography services by DEXTROSE TECHNOLOGIES

Documentation & Regulatory Support

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Phone Number

08048047702

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Mon-Thu: 10 AM - 2 PM • Fri: 3 PM - 7AM

Address

Chennai, India, 600001

Description

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.

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Elemental Analysis

At Dextrose Technologies Pvt. Ltd., we provide ICP-OES (Inductively Coupled Plasma – Optical Emission Spectroscopy) for reliable multi-element quantitative analysis across raw materials, intermediates, and finished products. ICP-OES is well suited for routine elemental profiling and screening where you need accurate concentrations across multiple metals and minerals in a single run (scope depends on matrix and required limits). Multi-Element Quantitative Analysis We quantify multiple elements in one method, generating concentration results in clear units (ppm/ppb or mg/L as required) with calibration-based reporting. Heavy Metal and Elemental Impurity Screening We support screening for heavy metals and elemental impurities to help identify contamination risks, support QC decisions, and enable batch comparison. (For ICH Q3D-aligned programs, scope and limits are finalized based on your requirements and standards provided.) Raw Material and Finished Product Analysis We analyze a wide range of matrices—raw materials, powders, liquids, digests, and finished products—based on suitable sample preparation and digestion approach. Deliverables * Results table with element-wise concentrations * Method notes (sample prep/digestion basis as applicable) * Calibration approach and QC checks (as agreed) * Summary interpretation and flags for outliers/trends Get started Share your sample type, target element list, required limits, and reporting units. We’ll recommend the right ICP-OES workflow and sample preparation plan.

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Elemental Analysis

At Dextrose Technologies Pvt. Ltd., we offer Atomic Absorption Spectroscopy (AAS) for accurate, targeted metal quantification in APIs, excipients, formulations, and raw materials. AAS is well suited when you need focused testing of specific metals with dependable calibration-based reporting. We support heavy metal testing and routine elemental checks for quality, troubleshooting, and compliance-focused workflows (scope and limits defined by your requirement). Targeted metal quantification We quantify selected metals based on your target list and matrix, with results reported in clear units (ppm/ppb or mg/L as required). Heavy metal testing in APIs, excipients, and formulations We test for heavy metals in pharmaceutical and formulation samples to support QC decisions and risk evaluation, with clean documentation and structured reporting. Deliverables * Metal-wise concentration results with units * Method notes and sample preparation basis (as applicable) * Calibration approach and QC checks (as agreed) * Summary interpretation highlighting any outliers Get started Share your sample type, target metal list, required limits, and reporting units. We’ll recommend the most suitable AAS workflow.

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At Dextrose Technologies Pvt. Ltd., our Technical Reporting & Failure Analysis Support ensures you don’t just receive raw outputs—you receive clear conclusions, high-quality visuals, and documentation that stands up to review. We combine SOP-driven execution with expert interpretation to support R&D decisions, QC investigations, and client submissions. SOP-Driven Testing All testing is performed using standardized workflows with traceable sample handling and documented instrument/test conditions. High-Resolution Images and Data Interpretation We provide high-resolution images and structured interpretation to highlight critical observations, anomalies, and trends—so your team can act quickly and confidently. Client-Specific, Regulatory-Style Reports We deliver clean, review-ready reports aligned to your format needs, including results tables, images/plots, method notes, and clear conclusions. Comparative and Failure Analysis Studies We support comparative studies across batches/conditions and root-cause investigations for defects, contamination, and performance issues—linking evidence to actionable insights.