ANALYTICAL TECHNOLOGY

Analytical Technologies: Comprehensive Testing Solutions

TechnoPharmaSphere utilizes a range of advanced analytical technologies to provide precise characterization and quality assessment of biopharmaceutical products. Our state-of-the-art technologies include:

Spectroscopy Techniques

Spectroscopy is essential for analyzing molecular structure, configurations, and interactions in biopharmaceutical research. Using advanced spectroscopic tools, we offer critical insights across the drug development pipeline. Key capabilities include:

- Detailed Molecular Structure Analysis:
  Provides precise structural data for small molecules and complex biologics, aiding in therapeutic design and functionality.
- Functional Group Identification:
  Detects key functional groups that influence compound properties and interactions, facilitating optimized formulation.
- Molecular Vibration Analysis:
  Investigates molecular vibrations, offering insights into composition and stability for APIs and excipients.
- Chirality and Stereochemistry:
  Evaluates chiral properties essential for assessing bioactivity and safety.
- Comprehensive Quality Control:
  Ensures consistency across raw materials, APIs, and final formulations through rigorous spectral verification.

Fourier Transform Infrared (FTIR) Spectroscopy
An advanced molecular analysis tool used to determine the structural properties of compounds, essential for identifying functional groups and gaining insights into molecular configurations and dynamics.
Vibrational Circular Dichroism (VCD)
A technique that provides information on the stereochemistry and conformation of chiral molecules.
Raman Optical Activity (ROA)
Used for studying chiral molecules, offering insights into molecular structures.
Circular Dichroism (CD)
Useful for analyzing the secondary structure of proteins and nucleic acids.

Particle Analysis and Dissolution Testing

Laser Diffraction
This method is used to measure the size distribution of particles within a sample, ensuring consistency and uniformity in formulation.
USP II Like (Shaker Bath), USP IV Apparatus
Equipment used in dissolution testing to analyze drug release profiles under controlled conditions, crucial for bioavailability studies.

Detection Technologies

UV/DAD, ELSD, CAD Detectors
A range of advanced detectors, including UV Diode Array Detectors (DAD), Evaporative Light Scattering Detectors (ELSD), and CAD, ensure precise compound detection across a variety of samples.
LC/MS (Liquid Chromatography/Mass Spectrometry)
Combines liquid chromatography and mass spectrometry for precise molecular identification and mass determination of compounds.
Preparative HPLC
A high-capacity chromatography method used to purify larger quantities of compounds for further research or product development.

Gas Chromatography

Gas Chromatography/FID (Flame Ionization Detection)
A method used for analyzing volatile compounds in pharmaceutical samples, providing accurate quantification and identification.

Dissolution

The process of testing how a drug dissolves in various media to understand its release profile, which is key to its bioavailability and therapeutic effectiveness.

Spectrophotometry and Moisture Analysis

UV/VIS Spectrophotometer
Measures the absorbance of samples in the ultraviolet and visible spectrum, enabling concentration analysis of compounds.
Karl Fischer Titration
A precise technique to measure the water content in a sample, which is critical for ensuring the stability and quality of the product.

Stability Testing

Photostability Chamber (ICH)
Ensures products maintain their stability when exposed to light according to ICH guidelines.
ICH Stability Chambers
Stability chambers set to industry-standard conditions (25°C/60%RH, 30°C/65%RH, 40°C/75%RH) to assess the long-term stability of pharmaceuticals under varied conditions.
Variable Temperature/Humidity Controlled Ovens
Specialized equipment to simulate and assess the stability of products under fluctuating temperature and humidity environments.

Nanoparticle Manufacturing and Characterization

Nanoparticle Manufacturing Systems
Cutting-edge equipment including Microfluidics, T-mixers, Impingement Jet Mixers (IJM), Solvent-based Lipid Emulsification, and Tangential Flow Filtration (TFF) for creating precise nanoparticle formulations.
Nanoparticle Characterization Systems
Advanced techniques for analyzing the size, distribution, and physical properties of nanoparticles, which are vital for the development of nanoparticle-based drug delivery systems.

Gel Electrophoresis
A technique used for the separation of proteins, nucleic acids, and other complex molecules based on their size and charge.
Dynamic Light Scattering (DLS)
Used to determine particle size distribution by analyzing the scattering of light as it passes through a sample.
Electrophoretic Light Scattering (ELS)
Measures the charge (zeta potential) of particles in a suspension, which is essential for understanding their stability and behavior in various formulations.

Thermal and Mechanical Analysis

Differential Scanning Calorimetry (DSC)
Measures how materials change as they are heated or cooled, providing insights into thermal transitions such as melting points and glass transitions.
Thermogravimetric Analysis (TGA)
Assesses the thermal stability and composition of materials by measuring changes in weight as they are heated.
Simultaneous Differential Thermal Analysis
Combines DSC and TGA for simultaneous analysis, providing detailed insights into both the thermal stability and composition of materials.
Thermomechanical Analysis (TMA)
Measures changes in a material’s physical properties as it is heated or cooled, which helps in understanding material behavior under stress.
Dynamic Mechanical Analysis (DMA)
A technique used to study the mechanical properties of materials under stress, such as elasticity and viscosity.

Rheological Measurements

Rheology
Rheological analysis characterizes the flow and deformation properties of complex fluids and semi-solid materials, which is essential for product formulation and manufacturing.