Analytical Services
- LCMS-MS Analysis (Triple Quadrupole)
Achieve precise, ultra-sensitive detection with Triple Quadrupole LCMS-MS. Perfect for quantifying and identifying compounds in complex samples across pharmaceuticals, environmental, and biological sectors.
- Direct Mass Analysis
Perform rapid, accurate analysis directly with mass spectrometry, eliminating sample prep. Ideal for quick substance identification and real-time testing in diverse applications.
- LCMS-MS Method Development
Customize LCMS-MS protocols to optimize separation and detection conditions, ensuring maximum accuracy and compliance with regulatory standards for your specific needs.
- Unknown Impurity Isolation & Identification
Unknown impurity isolation by Flash Chromatography OR Preparative Chromatography. Identification of unknown impurities by several analytical techniques like LC-MS/ Direct Mass, 1HNMR, 13CNMR & FTIR etc. which is useful in quality control in pharmaceuticals, food, and environmental testing.
- HPLC Routine Analysis & Method Development
Ensure consistent, accurate results with HPLC for routine analysis and personalized method development, tailored for the pharmaceutical, food, and environmental industries.
- GC Routine Analysis & Method Development
Maximize the precision of GC analysis with refined methods for routine testing, ideal for volatile compound detection in environmental, food, and petrochemical industries.
- Analytical Method Validation
We ensure the accuracy, precision, and robustness of analytical methods in line with global regulatory guidelines. Our validation process guarantees reliable and reproducible results across various dosage forms.
- Analytical Method Development
Our expert team designs and optimizes analytical methods with high sensitivity, selectivity, and accuracy. We tailor our approach to meet your product's unique needs, ensuring efficiency and compliance.
- Extractable & Leachable Studies
We identify and assess potential contaminants from packaging materials that could migrate into your product. Our studies mitigate risks and ensure compliance with stringent regulatory requirements.
- Technology Transfer
We facilitate seamless analytical method transfers between laboratories or manufacturing sites. Our process ensures method consistency, reproducibility, and regulatory acceptance, minimizing risks during scale-up.
- Multimedia Dissolution Profile
Our dissolution studies evaluate drug release across different media to predict in-vivo performance. This data supports bioequivalence assessments and helps optimize formulation strategies.
- Forced Degradation Studies
By subjecting drug substances and products to extreme conditions, we identify degradation pathways. These studies provide critical insights for formulation stability and regulatory submission.
- Pre-formulation Studies
We analyze the physicochemical properties of drug substances, including solubility, stability, and compatibility. This data guides formulation strategies to enhance drug performance and manufacturability.
- Genotoxic Impurities Assessment
We detect and quantify potential DNA-reactive impurities to ensure patient safety. Our assessments align with regulatory guidelines, providing a comprehensive impurity risk profile.
- Residual Solvents Analysis
Our advanced analytical techniques identify and control residual solvents in pharmaceuticals. We ensure compliance with ICH guidelines and safeguarding product quality.
- Quantification of Polymorphs by XRD
Using X-ray diffraction (XRD), we characterize and quantify polymorphic forms to maintain consistency. Understanding polymorph distribution is crucial for ensuring product stability and efficacy.
- Stability Studies
We conduct ICH-compliant stability studies to evaluate the shelf life and optimal storage conditions of pharmaceutical products. Our data supports regulatory filings and ensures long- term product integrity.
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