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.