Analytical R&D at Conscio supports pharmaceutical development and registration with services including analytical method development, impurity identification, degradation and stability studies, trace analyses, nitrosamines testing, extractables and leachables studies, IVRT/IVPT method development and other non-GMP analytical services.
We help solve challenges such as ensuring method suitability for complex formulations, replacing outdated pharmacopoeial methods, investigating unknown impurities, and verifying product stability under various stress conditions. Our laboratories are equipped with advanced chromatographic, spectrometric and dissolution systems, enabling precise, reliable and regulatory-compliant results that support both development and manufacturing.
The development and validation of analytical methods is a core part of our work, supporting projects from early R&D to routine quality control.
We are typically involved when:
Assay and related substances methods are usually designed and validated using techniques such as HPLC or UPLC with UV, RI, fluorescence, ELSD or CAD detection for purity and assay testing. LC/MS is applied for trace analysis due to high selectivity and sensitivity. GC with FID or MS detection is proposed for volatile analytes ((e.g. for residual solvents testing as per ICH Q3C), ion chromatography for highly polar compounds, dissolution systems for formulation and QC studies, and ICP-MS for elemental impurities in line with ICH Q3D. Each method is tailored to the analyte, matrix and performance requirements, and delivered with full documentation for GMP or R&D use.
Identifying and characterising impurities is essential for product safety and regulatory compliance. This work is required when some unknown impurity peak in chromatographic analysis appears at level exceeding the identification threshold (usually 0.1%).
Our scientists determine impurity structures to distinguish between process-related and degradation-related species, enabling targeted process improvements or, where justified, setting higher acceptable limits. LC/MS or GC/MS — including high-resolution and ion-trap configurations — allows accurate identification of impurities in both volatile and non-volatile forms. When needed, preparative chromatography is used to isolate the impurity followed by NMR to confirm structures. Depending on content and separation efficiency, tens to hundreds of milligrams can be provided for toxicological testing or preparation of certified reference standards.
The result is clear identification of each impurity, suggestion of impurity origin, or provision of isolated material or reference standards to support quality control and regulatory submissions.
We prepare analytical reference standards for identified impurities or related substances to ensure consistent, reproducible testing and regulatory compliance. Materials are synthesised in-house using reaction routes developed during structure elucidation or conventional synthetic methods, and when necessary, we coordinate production with trusted external laboratories.
Capabilities:
Clients receive a certified, fully characterised standard ready for immediate use in analytical method validation and ongoing quality control.
Forced degradation and accelerated stability studies are performed to evaluate how active ingredients and finished products respond to environmental and chemical stress.
Test conditions include:
Excipient compatibility studies are also conducted to identify potential interactions between active ingredients and formulation components. Analytical evaluation uses checked chromatographic, spectrometric and dissolution techniques to generate reliable data on degradation pathways, impurity formation and product compatibility.
Results support formulation development, analytical method development, and estimation of product shelf-life.
Highly sensitive methods are developed and validated for detecting and quantifying trace-level impurities, often at concentrations far below regulatory thresholds. This is particularly important for substances with low permitted daily exposure (PDE) limits or products with complex matrices.
Using LC/MS and GC/MS systems — including high-resolution and triple quadrupole configurations, we achieve the detection limits necessary for accurate identification and quantification of trace contaminants. These methods ensure confident compliance with strict regulatory limits and provide robust data for risk assessment.
Nitrosamine testing is carried out in active pharmaceutical ingredients (APIs) and finished products, covering both small molecule nitrosamines (e.g., NDMA, NDEA) and nitrosamine drug substance-related impurities (NDSRIs). High-sensitivity UPLC systems coupled with triple quadrupole and high-resolution mass spectrometers deliver accurate, reproducible results in simple and complex matrices.
These validated methods meet EMA and FDA requirements, ensuring product safety, regulatory compliance and prevention of contamination-related recalls.
Extractables and leachables studies are conducted for primary and secondary packaging, medical devices and manufacturing equipment to identify potential contaminants that could migrate into the product during its manufacturing, shelf life or use. These studies are conducted to ensure patient safety, prevent manufacturing issues. The studies are designed to comply with relevant guidelines, including EMA CPMP/QWP/4359/03, USP <1663>, USP <1664>, USP <665>/<1665>, ISO 10993-18 and the draft ICH Q3E.
Capabilities:
The outcome is a complete extractables profile and validated leachables methods, enabling early detection and control of risks.
In vitro release testing (IVRT) and in vitro permeation testing (IVPT) methods are developed and validated for topical drug products in line with EMA and FDA guidelines. These studies demonstrate product performance and equivalence, particularly for generic formulations.
Testing is performed using vertical diffusion cell systems and flow-through apparatus with semisolid adapters, with analytical finishes by HPLC-UV or UV spectrophotometry. Validation follows ICH Q2(R2) and relevant EMA or FDA requirements, generating robust data for regulatory submissions and confirming product quality and consistency.
Quantitative determination of excipients in drug products is needed, when equivalence in product composition should be provided, when competitor product composition should be investigated or when excipient quantitation is necessary for control of the manufacturing process. Many excipients are polymers, and their quantitation requires unconventional analytical approaches, especially in complex formulations. Quinta R&D team offers years of experiences in this field and many successful case studies.
Qualitative investigation of excipients in drug products may include testing with SEC, MS, NMR, IR, Raman, XRPD, DSC, TGA, rheology and other techniques.
Isolation and identification of contamination particles in solid or liquid drug product forms can be conducted. Depending on the particle size and nature, the identification can be achieved by combination of different techniques including e.g. IR (or IR-microscope), Raman (or Raman microscope), SEM-EDS, XRPD, MS, NMR, ICP-MS.
Let’s talk. Whether you’re scaling operations or prepping for your next audit, we’ll help you take the next confident step.
