API Physical & Chemical Characterization

Preformulation is a key stage of drug development, We have professional pharmaceutical scientists who can conduct research from routine to highly complex and challenging characterization. CD Formulation can perform physical and chemical characterization of active pharmaceutical ingredients (APIs) and pharmaceutical products in all stages of the drug development process. We can provide test characterization reports and summarize all investigation results.

Our API Physical & Chemical Characterization Services

• Test characterization reports.
• Summarize all investigation results.

Physical Characteristics Test Capability

XRPD Characterization

Method development (identification, limit testing, etc.) of the crystalline and amorphous ratios of API and excipients depends on each composition.

Particle Size Determination

• The particle size distribution of multiple technologies covers a wide range of size intervals.
• Capable of analyzing wet emulsions, suspensions and bulk dry dispersions.
• Identify different sample types: abrasive, fragile, sticky or agglomerated.

Morphological Analysis

• The description of the specific composition of the particle mixture.
• Identify particles by morphologically oriented Raman spectroscopy.
• Control the particle size and shape of API and excipients during the development process and throughout the formulation and processing process.
• Simplify the modification challenge of generic drugs to support in vitro bioequivalence.
• Detect abnormalities and contaminants during the manufacturing process and identify process deviations.

Surface Area

• Calculate BET surface area (single point or multiple points).
• Predict reactivity, solubility and compactness.

Microscope

• Size and shape analysis by scanning electron microscope.
• Polarizing Microscope (PLM).

Differential Scanning Calorimetry

• Direct measurement of heat capacity.
• Analyze complex and overlapping thermal changes-with modulated DSC function.
• Detects weak thermal changes.

Thermogravimetric Analysis

• Measure the change of sample quality with temperature and/or time.
• Monitor moisture/solvent loss (micro-scale LOD).
• Determine the chemical degradation rate at different temperatures.
• Measuring gas absorption-desorption.

Chemical Characteristics Test Capability

NMR

• Identify chemical structure.
• Quantification of residual solvents.

Fourier Transform Infrared and Near-infrared Absorption Spectra

• Known scan fingerprint recognition.
• Recognize functional groups in molecular structure.
• Use photoacoustic scanning to identify resin and opaque/colored materials.

Ultraviolet Visible Absorption Spectrum

• Determine the characteristic absorption mode of raw materials.
• For qualitative detection, quantitative calculation and kinetic analysis.

Why Choose CD Formulation?

Fully integrated products supporting drug development (early to late).

Long-term expertise in on-site solid-state characterization to support the development of custom and proprietary active pharmaceutical ingredients.

Comprehensive state-of-the-art equipment can achieve high capacity and rapid turnover, support development, stability and mass release.

Develop internal common methods for various technologies without the need to develop methods from scratch.

Our Advantages

If you have a requirement about API physical & chemical characterization services, please contact us by phone or email, our colleagues will reply to you within three working days.