Analytical Services Details

We specialize in developing robust and reproducible analytical methods to support drug development and manufacturing. Our services include method development for assay, content uniformity, related substances, and dissolution. Using techniques like HPLC, GC, UV, and IR, we tailor each method to compound characteristics and regulatory needs. We also evaluate method ruggedness and specificity. Each method is transferred and optimized for scalability and routine QC use. Our team ensures regulatory-compliant documentation for regulatory submissions. We support both novel and generic pharmaceutical products.

Our method validation services comply with ICH Q2(R1) guidelines, covering parameters such as accuracy, precision, linearity, specificity, robustness, and detection limits. We validate methods developed in-house or provided by clients. Validation reports include all raw data, chromatograms, and statistical analysis. Each validated method is suitable for regulatory filings and routine quality control. We work across a wide range of dosage forms and molecule types. Our experienced team ensures each method meets global regulatory standards. Full validation protocols and summaries are provided with each project.

We perform ICH-compliant stability studies to assess the shelf life and storage conditions of APIs and formulations. Our infrastructure supports long-term, intermediate, and accelerated conditions. We also offer forced degradation studies to identify degradation pathways and potential impurities. Analytical testing is performed at predefined intervals and includes assay, degradation product analysis, and physical attributes. Stability-indicating methods are validated for accuracy and precision. All data is compiled into regulatory-ready reports. Our studies ensure compliance with global market requirements.

Our impurity profiling services provide identification, characterization, and quantification of known and unknown impurities. We use high-end techniques such as LC-MS/MS, GC-MS, and NMR to achieve detailed profiling. Structural elucidation and synthetic confirmation are also available. Our profiling supports regulatory submissions, stability studies, and API development. Reports are generated in compliance with ICH Q3A and Q3B guidelines. Our approach helps ensure product safety and regulatory acceptance. We provide solutions for both process and degradation impurities.

We conduct residual solvent testing in accordance with ICH Q3C guidelines using headspace GC and direct injection methods. Our services ensure that residual solvents in APIs and drug products are within permitted daily exposure limits. We provide class-specific quantification (Class I, II, III) with validated methods. Testing is conducted on raw materials, intermediates, and final products. Detailed certificates and reports are provided for regulatory filings. This service ensures product safety and manufacturing compliance. Rapid turnaround is available for developmental projects.

Our heavy metal testing service is conducted using ICP-MS and AAS techniques to detect toxic metals like lead, cadmium, arsenic, and mercury. Testing is performed according to USP <231>, <232>, and ICH Q3D guidelines. We test raw materials, intermediates, APIs, and finished products. Quantitative and qualitative data is provided with detailed COAs. Our facilities are equipped for trace-level detection and compliance monitoring. This service is critical for ensuring the safety and regulatory compliance of pharmaceutical products. Reports are formatted for submission to global regulatory authorities.

We provide elemental analysis services for carbon, hydrogen, nitrogen, sulfur, and oxygen determination using CHNS/O analyzers. This analysis is essential for structure confirmation and purity assessment. Our services support new compound characterization, batch consistency checks, and impurity profiling. Results are cross-verified with theoretical values to ensure accuracy. Reports include complete analytical data and interpretation. This testing is critical in research, API manufacturing, and regulatory documentation. We offer rapid results for both routine and custom samples.

Mass spectrometry is a core analytical tool we use for molecular weight determination, structure elucidation, and impurity identification. We utilize LC-MS, GC-MS, and HRMS platforms to support a broad range of compounds. Our services are used in both qualitative and quantitative applications. We offer high-resolution and accurate mass data to support structural analysis. This technique is essential in drug discovery, method development, and impurity profiling. We also support metabolite identification and degradation product analysis. Results are interpreted by expert analysts for clarity and reliability.

Nuclear Magnetic Resonance (NMR) spectroscopy is used for structural elucidation and confirmation of complex molecules. We offer both 1D and 2D NMR services, including 1H, 13C, COSY, HSQC, and HMBC. Our NMR services support structure validation, stereochemistry, and impurity identification. High-field NMR instruments are available for sensitive and complex samples. Each report includes spectral data, interpretation, and assignment tables. This service is essential in API development and regulatory submission. Custom experiments are available based on client needs.

We provide High-Performance Liquid Chromatography (HPLC) analysis for assay, related substances, and dissolution profiling. Our capabilities include reverse-phase, normal-phase, ion-exchange, and chiral HPLC. Equipped with UV, PDA, and ELSD detectors, we ensure sensitive and precise analysis. Each method is developed and validated to meet regulatory standards. Applications span R&D, QC, and stability testing. HPLC is suitable for a wide range of pharmaceutical compounds. Data is provided in validated formats suitable for regulatory submission.

Gas Chromatography (GC) analysis is performed for volatile compound quantification, residual solvent testing, and content uniformity studies. We use both FID and MS detectors for flexibility in qualitative and quantitative analysis. Our GC methods comply with pharmacopeial and ICH guidelines. The technique is suitable for raw materials, APIs, and formulations. We develop and validate methods tailored to specific sample matrices. Our systems support high-throughput testing with accurate and reproducible results. Complete documentation and COAs are included with each analysis.

We offer UV-Visible spectroscopy services for qualitative and quantitative analysis of pharmaceutical substances. This technique is widely used for compound identification, concentration estimation, and dissolution profiling. Our team ensures proper wavelength selection and method validation to enhance accuracy. UV-Vis is suitable for both routine and research-based projects. We provide full spectral scans and absorbance data interpretation. The service supports API development, stability studies, and impurity quantification. Reports include raw data and method details as per regulatory norms.

Karl Fischer titration is a precise technique used to determine water content in raw materials, intermediates, and finished pharmaceutical products. We utilize both volumetric and coulometric methods depending on sample type and moisture levels. This analysis helps ensure compliance with pharmacopeial standards and supports stability studies. Our validated procedures offer high sensitivity for trace-level moisture detection. It is particularly useful in hygroscopic APIs and formulations. Reports include moisture content, instrument calibration, and test conditions. This testing is critical for quality control and release specifications.

Our dissolution testing service evaluates the release profile of drug products under standardized conditions. We perform testing using USP Apparatus I and II, as well as customized setups for complex formulations. Each study is conducted under validated conditions with time-point sampling and media analysis. This is crucial for formulation development, bioequivalence, and QC testing. We also offer method development, validation, and comparative dissolution profiling. Data interpretation includes dissolution efficiency, f2 metrics, and regulatory-compliant reporting. Our facility supports both R&D and GMP batch testing.

We provide particle size analysis services using laser diffraction and dynamic light scattering (DLS) methods. This testing helps evaluate product performance, stability, and dissolution behavior. It is especially critical for nanomaterials, suspensions, and inhalation products. Results include D10, D50, D90 values, mean particle size, and distribution curves. Our facility supports both wet and dry dispersion measurements. Sample preparation is optimized to prevent aggregation or degradation. Each test is performed under strict QA procedures with detailed reporting.

Fourier-Transform Infrared (FTIR) spectroscopy is used to identify functional groups and verify compound identity. We provide qualitative and quantitative FTIR analysis using transmission, ATR, and KBr pellet techniques. FTIR is applicable for API characterization, excipient compatibility, and raw material testing. Our instruments cover a wide spectral range with high resolution. We generate spectra libraries and offer spectral matching for unknown compounds. Each analysis includes interpretation, peak assignment, and a detailed report. FTIR is also used in polymorph and salt screening projects.

We offer thermal analysis services including Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) to assess material stability and transitions. DSC evaluates melting point, polymorphism, and glass transition temperatures. TGA determines thermal stability and decomposition profiles. These methods are essential for preformulation, compatibility studies, and material selection. We use high-precision instruments with software-integrated data interpretation. Thermal analysis helps define storage and processing conditions for APIs and excipients. All studies are conducted under controlled atmosphere with complete documentation.

Microbial limit testing is performed to ensure the microbiological safety of pharmaceutical products. We conduct tests for total aerobic microbial count (TAMC), total yeast and mold count (TYMC), and specific pathogen identification. Testing is in compliance with USP <61> and <62>. Our microbiology lab operates under aseptic and validated conditions. These tests are critical for oral solids, topical formulations, and raw materials. We provide both qualitative and quantitative results with COAs. The service ensures that microbial contamination is within acceptable limits.

Total Organic Carbon (TOC) analysis is used to detect organic contamination in pharmaceutical water systems and cleaning validation samples. We use high-sensitivity TOC analyzers compliant with USP <643> and EP standards. This test supports water for injection (WFI), purified water, and rinse samples. Our team ensures calibration with certified standards and performs method suitability for each application. Results include TOC concentration in ppm with full documentation. TOC testing is essential for GMP compliance and cleaning effectiveness verification.

We offer pH and conductivity testing to assess the chemical stability and ionic content of pharmaceutical solutions. pH testing is performed using calibrated meters with appropriate buffers as per pharmacopeial methods. Conductivity testing determines ionic strength and water purity in compliance with USP <645>. These tests are essential for raw materials, in-process controls, and finished products. Results help ensure batch-to-batch consistency and formulation quality. All measurements are performed under validated conditions with traceable calibration records. Reports are formatted for regulatory submissions.