Analytical Services
Comprehensive Analytical Services and Cutting-Edge Technologies
At TechnoPharmaSphere, our Analytical Services are designed to support biopharmaceutical development at every stage of the product lifecycle. Our team of experts utilizes state-of-the-art technologies and methodologies to provide precise and reliable analytical data, enabling our clients to make informed decisions and ensure the quality, safety, and efficacy of their products.
Our state-of-the-art facilities and experienced team are dedicated to delivering reliable and accurate results that help you achieve your research and regulatory goals.
- Physicochemical Characterization
- Comprehensive physicochemical characterization is crucial for understanding the properties of therapeutic candidates. Our services include:
- Size and Distribution Analysis: Utilizing techniques such as Dynamic Light Scattering (DLS) and Nanoparticle Tracking Analysis (NTA) to determine particle size and distribution for nanoparticles and biologics.
- Surface Charge and Zeta Potential Measurement: Assessing the stability and interaction of formulations through zeta potential analysis.
- Morphological Characterization: Employing electron microscopy techniques (SEM and TEM) to visualize and characterize the morphology of nanoparticles and proteins.
- Content and Purity Analysis
- Ensuring the identity, potency, and purity of biopharmaceutical products is essential. Our analytical services include:
- High-Performance Liquid Chromatography (HPLC): Used for quantifying active ingredients and determining purity levels.
- Mass Spectrometry (MS): For detailed analysis of molecular weight, structure, and composition, allowing for precise identification of compounds.
- Protein Quantification: Utilizing UV-Vis spectroscopy and other techniques for accurate determination of protein concentration.
- Stability Testing
- Stability studies are vital for assessing the shelf-life and storage conditions of pharmaceutical products. We offer:
- Accelerated Stability Studies: Conducting studies under stress conditions to predict product stability over time.
- Real-Time Stability Studies: Monitoring product stability under recommended storage conditions, providing essential data for regulatory submissions.
- Method Development and Validation
- We provide tailored method development and validation services to ensure that analytical methods are robust, reliable, and compliant with regulatory standards. This includes:
- Analytical Method Development: Customizing methods for the specific requirements of our clients’ products, ensuring specificity and sensitivity.
- Method Validation: Rigorous validation of methods according to ICH guidelines, including assessments of specificity, accuracy, precision, linearity, and robustness.
- Biophysical Analysis
- Understanding the biophysical properties of biomolecules is critical for formulation development. Our services encompass:
- Thermal Analysis: Techniques such as Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) to evaluate thermal stability and phase transitions.
- Circular Dichroism (CD) Spectroscopy: Used to assess protein secondary structure and conformational stability.
- Dynamic Mechanical Analysis (DMA): For evaluating mechanical properties of formulations, particularly in polymeric systems.
- Specialized Analytical Techniques
- Our state-of-the-art facility is equipped with specialized instruments for advanced analytical assessments, including:
- Fourier Transform Infrared Spectroscopy (FTIR): For qualitative and quantitative analysis of functional groups in complex mixtures.
- Raman Spectroscopy: Employed for molecular characterization and monitoring interactions between drug components.
- Surface Plasmon Resonance (SPR): For real-time monitoring of biomolecular interactions, providing insights into binding kinetics and affinities.
- Regulatory Compliance and Support
- Navigating the regulatory landscape is crucial for successful product development. Our analytical services are designed to align with regulatory standards, ensuring that our clients meet the necessary requirements for submission to agencies such as the FDA, EMA, and ICH.
Method Development, Validation, and Stability Studies
Our Method Development, Validation, and Stability Studies service provides comprehensive support for ensuring the quality and safety of pharmaceutical products. These services play a critical role in the drug development process by establishing and validating analytical methods, as well as monitoring product stability over time. By delivering precise and reliable data, we help clients meet regulatory standards and optimize product quality from early development through to commercialization.
Method Development: Our method development process involves creating customized analytical techniques to detect, identify, and quantify active pharmaceutical ingredients (APIs), impurities, and degradation products in various formulations. We work closely with clients to optimize methods for specific requirements, ensuring sensitivity, accuracy, and robustness. This process includes the selection of suitable analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), or Mass Spectrometry (MS), tailored to the unique properties of the substances being analyzed.
Method Validation: To ensure that developed methods consistently deliver reliable results, we conduct rigorous validation procedures according to established guidelines such as those from the ICH, FDA, and EMA. Method validation covers key parameters, including accuracy, precision, linearity, specificity, LOD, LOQ, and robustness. Each parameter is assessed under controlled conditions to confirm that the method can be applied effectively for routine quality control and regulatory submissions.
Stability Studies: Stability studies are essential for determining how pharmaceutical products respond to environmental factors over time, such as temperature, humidity, and light. Our stability studies adhere to GMP standards and are conducted in accordance with ICH guidelines. By storing samples in controlled stability chambers, we can monitor changes in the physical, chemical, and microbiological properties of the product. This data supports decisions regarding shelf-life, storage conditions, and packaging requirements.
Thermal Analysis
Thermal Analysis is a vital component of our Analytical Services, providing crucial insights into the thermal properties and behavior of pharmaceutical materials. By assessing the response of substances to changes in temperature, this service helps in understanding material stability, compatibility, and processing characteristics, ensuring the development of safe and effective drug products. Our thermal analysis capabilities support various stages of drug development, from formulation to manufacturing.
Differential Scanning Calorimetry (DSC): DSC is used to measure heat flow associated with material transitions such as melting, crystallization, and glass transition temperatures. This analysis helps determine the thermal stability and purity of active pharmaceutical ingredients (APIs) and excipients. It also aids in assessing polymorphism, which is crucial for selecting the most stable and bioavailable form of a drug compound.
Thermogravimetric Analysis (TGA): TGA measures weight changes in a material as it is heated, providing information on thermal stability and composition. This technique is used to detect decomposition temperatures, moisture content, and residual solvents in pharmaceutical samples. Understanding these parameters is essential for optimizing storage conditions and manufacturing processes.
Dynamic Mechanical Analysis (DMA): DMA evaluates the mechanical properties of materials under varying temperatures and frequencies. It is used to characterize the viscoelastic behavior of polymers and other materials in formulations. This information is particularly valuable in developing drug delivery systems such as controlled-release formulations or medical devices where material flexibility and strength are critical.
Hot Stage Microscopy (HSM): HSM involves visual observation of a sample while it is being heated, allowing for the identification of physical changes like melting, crystallization, or sublimation. This technique is beneficial for studying material morphology and understanding the thermal events that occur during processing or storage.
Mechanical Characterization
Mechanical Characterization is an essential part of our Analytical Services, focusing on evaluating the mechanical properties of pharmaceutical materials and formulations. By understanding the strength, flexibility, and other mechanical attributes, we can ensure the stability, quality, and performance of drug products. This analysis helps in optimizing formulations and enhancing the manufacturing process, making it integral to product development in the pharmaceutical industry.
Hardness Testing: Hardness testing measures the resistance of a material to deformation or penetration, which is important for evaluating tablet or capsule integrity. It helps ensure that drug products maintain their shape and structure during packaging, transportation, and patient use. This testing is crucial for developing robust formulations that meet regulatory requirements for mechanical strength.
Tensile and Compressive Strength Analysis: This analysis assesses the material’s ability to withstand forces that pull apart (tensile) or push together (compressive). It is particularly useful in evaluating materials used in drug delivery systems like films, patches, and medical devices. Understanding these properties helps in selecting materials with the appropriate mechanical characteristics for specific applications.
Elasticity and Flexibility Testing: By measuring the elasticity and flexibility of materials, we can determine how well they will perform under mechanical stress. This is vital for products such as transdermal patches, which need to conform to the skin’s movement without losing adhesion or drug delivery performance.
Fracture Analysis: Fracture analysis involves studying how and why a material breaks under stress. This is useful for identifying weaknesses in formulations and improving the durability of products, particularly in solid dosage forms like tablets that may be subject to mechanical forces during manufacturing and handling.
Rheological measurements
Rheological Measurements play a critical role in our Analytical Services by analyzing the flow and deformation behavior of materials. This service is essential for understanding the viscosity, elasticity, and viscoelastic properties of pharmaceutical formulations. By characterizing these properties, we can optimize the formulation process, ensure consistent manufacturing, and enhance the performance and stability of various dosage forms, such as liquids, creams, gels, and semi-solids.
Viscosity Analysis: Viscosity testing determines the thickness and flow resistance of liquid or semi-solid formulations. It is crucial for ensuring the consistency of products like syrups, suspensions, and creams. Proper viscosity levels ensure ease of application and uniform dosage delivery, affecting the overall effectiveness and user experience.
Shear Stress and Shear Rate Testing: This type of testing evaluates how materials respond to different forces, simulating conditions they might encounter during manufacturing or application. Understanding shear behavior helps in designing formulations that remain stable under various conditions, ensuring that products retain their properties during production and storage.
Yield Stress Measurement: Yield stress is the amount of stress required for a material to start flowing. This is important for products like ointments or gels that need to remain solid under normal conditions but flow easily when applied. Accurately measuring yield stress helps optimize product performance, ensuring ease of use for patients while maintaining stability.
Time-Dependent Rheological Properties: Some materials exhibit changes in viscosity over time or with continuous use, a property known as thixotropy or rheopexy. By studying these time-dependent behaviors, we can improve the formulation process, ensuring that products like topical gels maintain their consistency and effectiveness over extended periods.
