Development and Validations
Method validation and development must be completed to determine the performance characteristics required for the intended analytical application. Depending on these characteristics, the validation parameters may vary. Typically, we adhere to ICH, FDA, and USP guidelines for method validation.
Laxus Labs is home to a senior-level technical team that specializes in method development and ICH method validation services. With years of experience, our team has expertise in developing stability-indicating methods, residual solvent methods, dissolution methods, and specific and non-specific cleaning validation methods. We have developed our own protocols, in line with ICH and FDA guidelines, though we are also capable of following client-provided protocols. We offer both pharmaceutical method development services and USP method validation services. Our capabilities extend to a variety of technologies such as PSD, ICP, HPLC, UV, and GC. Our technical team is well-versed in HPLC method development, HPLC validation, GC method development, and GC validation. These techniques are employed to develop and validate methods for APIs, intermediates, raw materials, and finished products. After each project, we provide a comprehensive report that includes a detailed step-by-step method.
The report includes the following parameters:
- Precision
- Intermediate Precision and Ruggedness
- Linearity
- Accuracy
- Range
- Specificity
- Forced Degradation Studies
- Limit of Detection/Limit of Quantification
- Stability of Standard and Sample Solutions
- Photo stability study
- Robustness
With extensive experience, Laxus Labs has handled a variety of analytical tests across drug substances, products, and medical devices. We guarantee that each analytical method development and validation project is conducted with the highest standards of quality and attention. Our experience spans all phases of pharmaceutical development (Phase I, II, and III).
SERVICES
The Laxus Labs team has vast experience leading all stages of stability and photo stability studies, from protocol design to storage, monitoring, testing, and documentation. Our facilities feature a range of climatic chambers for long-term and accelerated stress conditions, and we also provide customer-specific conditions if needed. These chambers are equipped with backup systems, 24×7 monitoring, and alert systems.
Extractables & Leachables refer to impurities that originate from primary packaging materials or process equipment. Our expert scientists are well-versed in performing these studies according to Good Manufacturing Practices, PQRI recommendations, and FDA guidelines on both primary and secondary closure systems.
Our services extend to:
- Drug delivery systems
- Medical devices
- Parenterals
- Raw materials
Techniques We Use:
- LC/MS
- GC/MS
- ICP-MS
X-ray diffraction (XRD) provides insights into polymorphism, crystallinity, and the amorphous nature of solid formulations. Thermal analysis techniques like TGA measure physical property changes of a substance with temperature, including weight loss, melting points, and phase changes. Differential Scanning Calorimetry (DSC) is used to assess phase transitions and conformational changes, enabling quantification of temperature-dependent energetics.
Trace metal impurities pose a significant risk to pharmaceutical products, and we offer elemental analysis using ICP-MS for detecting trace metals at ultra-trace levels (ppb). This service helps prevent harmful effects on patients due to such impurities.
Genotoxic impurities are known to be harmful even at low concentrations. Regulatory bodies have set specific limits for these impurities in drug substances and products. We offer specialized services to detect genotoxic impurities using ICP-MS, GC-MS, and LC-MS techniques.
HPLC (IEX, SEC, RP, HIC, HILIC, NP, HPAEC, IC, affinity with UV, FL, RI, ELSD, MALLS and MS detection
CGE (UV, LIF), CGE-SDS (UV, FL, LIF), cIEF (UV, FL, MS), CZE (UV, LIF, MS)
CD, SoloVPE UV, FL, FT-IR, Raman, SEM-EDX NMR, DLS, MALLS, AUC
Osmolarity, density, viscosity (rolling ball, capillary, rheometer) nDSC, visible and subvisible particles (membrane microscopy, light obscuration, flow imaging)
Particle size determination (PSD), microscopy (optical, SEM, TEM), specific surface area, porosity, bulk and tapped density, X-ray diffraction (XRD, XRPD), differential scanning calorimetry (DSC), isothermal calorimetry, solution calorimetry, thermogravimetric analysis (TGA, TG-FTIR), dynamic/gravimetric vapor sorption (DVS/GVS), microscopy (optical), and water activity measurements. All methods are performed under GMP conditions to ensure quality and compliance.
APSD (NGI), DDU, droplet size distribution, spray pattern & plume geometry
Intrinsic, extrinsic, UV and HPLC readout, friability
LC-MS (Orbitrap, qTOF, Triple Quad), GC-MS, (Orbitrap, Triple Quad, Single Quad) CE-MS (cIEF-qTOF-MS, CZE-qTOF-MS), Hydrogen-Deuterium-Exchange Mass spectrometry HDX-MS (LEAP-PAL – Orbitrap-MS)
ICP-MS, ICP-OES, AAS, XRF
Cell-based bioassay, ELISA, western blotting, residual DNA (threshold analysis, qPCR), rodent parvoviruses, surface plasmon resonance, RNA and DNA sequencing
Bioburden, endotoxin, sterility, viral safety, cell biology methods and potency assays
Tailored Method Development and Rigorous Validation for Accurate Results
We specialize in developing and validating analytical methods for raw materials, intermediates, and finished products. Our process includes the selection of suitable techniques, validation of analytical parameters, and thorough performance testing, ensuring that the final method meets both regulatory and quality assurance requirements. With expertise in various domains including pharmaceuticals, food safety, and environmental testing, Laxus Labs is equipped to handle even the most complex testing requirements.
By leveraging our expertise in method development and validation, Laxus Labs supports your product’s journey from concept to market with tested, reliable results that guarantee the highest level of quality and regulatory compliance.
Do we need prescription for these testing?
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