Scope of Services:

1. Comprehensive Reverse Engineering and De-formulation
• Structured, science-driven analysis of reference products across ophthalmic, semi-solid, and solid oral dosage forms.
• Systematic breakdown of formulations to characterize API, excipients, polymorphic form, particle attributes, and in vitro release behavior.
• Creation of a detailed technical dataset to support generic formulation design, lifecycle management, and troubleshooting.
2. Analytical and Solid-State Characterization
• Identification and confirmation of the API and its crystal form or polymorph.
• Qualitative and semi-quantitative mapping of excipients—fillers, binders, disintegrants, lubricants, film-coating systems, and functional polymers.
• Evaluation of particle size distribution, morphology, and microstructure.
• Comparison of disintegration and dissolution behavior to elucidate release profiles.
• Generation of a de-formulation blueprint to design, optimize, or benchmark formulations against the RLD.
3. Q1/Q2/Q3 Assessment Package for Generic Development
• Supports ANDA and biowaiver submissions with a complete compositional and structural comparison framework.
4. Q1: Qualitative Sameness
• Demonstrates that the test formulation uses the same inactive ingredients as the reference product.
• Provides detailed information on each excipient’s chemical nature, grade, and functional role.
• Systematic identification of excipients through de-formulation, covering polymers, surfactants, plasticizers, preservatives, buffers, etc.
• Utilizes FTIR/Raman, HPLC/UPLC, LC–MS, DSC/TGA, XRD, microscopy, and ion chromatography.
• Delivers a Q1 qualitative excipient map to support regulatory arguments for sameness.
5. Q2: Quantitative Sameness
• Estimates excipient levels and compares the test formulation to the reference within an acceptable ±5% variability band.
• Develops selective analytical methods (HPLC/UPLC, LC–MS, GC/GC–MS, spectroscopic techniques) for excipient quantification.
• Applies mass-balance and material-balance approaches to reconcile total composition.
• Prepares a Q2 quantitative excipient profile showing estimated concentrations and alignment with the reference.
6. Q3: Physical and Structural Equivalence
• Examines physical, microstructural, and performance similarity beyond composition alone.
• Covers physical attributes (appearance, color, shape, hardness, friability, disintegration, integrity).
• Conducts solid-state and microstructural analyses (polymorphism, crystallinity, particle size, internal microstructure).
• Assesses rheology and texture for semisolids or suspensions.
• Performs comparative dissolution and in vitro performance studies per regulatory requirements.
• Integrates Q1/Q2/Q3 findings to confirm equivalence in composition, microstructure, and performance, ensuring robust generic product justification.
7. Elemental Impurity Analysis Our Elemental Impurity Analysis Service ensures compliance with the latest ICH Q3D and global regulatory requirements by accurately identifying and quantifying trace elemental impurities in drug substances, excipients, and finished products. These impurities can originate from raw materials, catalysts, manufacturing equipment, or packaging systems and must be strictly controlled to guarantee product safety and patient health.
• Advanced analytical determination using ICP–MS (Inductively Coupled Plasma–Mass Spectrometry) and AAS (Atomic Absorption Spectroscopy).
• Evaluation of Class 1, 2, and 3 elemental impurities per ICH Q3D limits.
• Comprehensive risk assessment and control strategy development during formulation and process design.
• Support for product development, technology transfer, and regulatory documentation.
• Periodic monitoring and verification of elemental impurity profiles throughout the product lifecycle.
Our expert scientists apply validated methodologies to provide reliable, high-sensitivity results, ensuring your products meet international safety standards while maintaining full regulatory compliance.
8. Nitrosamine Impurity Analysis Services Nitrosamines are recognized as potent genotoxic impurities that require stringent monitoring and control across APIs and finished pharmaceutical products. Our Nitrosamine Impurity Analysis Service provides robust analytical and risk-assessment solutions to identify, quantify, and eliminate trace nitrosamine contaminants, in line with EMA, FDA, and MHRA guidance.
• High-sensitivity detection and quantification of nitrosamines using LC–MS/MS and GC–MS platforms.
• Targeted screening for regulated species such as NDMA, NDEA, NMBA, DIPNA, and EIPNA, among others.
• Non-targeted exploratory analysis to identify unknown or process-derived nitrosamines.
• Risk assessment studies focusing on formation mechanisms linked to APIs, excipients, solvents, and manufacturing conditions.
• Development and validation of nitrosamine-specific analytical methods tailored to product type and matrix.
• Complete regulatory support for risk evaluation reports, CAPA plans, and submission-ready documentation.

Our services help pharmaceutical manufacturers proactively manage nitrosamine risk, achieve regulatory compliance, and safeguard both product quality and patient safety.