API, Excipient Screening and Characterization

API & Excipient

API stands for active pharmaceutical ingredient, which is the part of a drug that produces the intended therapeutic effect. While the API is responsible for producing the desired pharmacological effect, excipients play a central role in the drug development process. They are widely used in pharmaceutical products such as tablets, capsules, oral solutions, and injections to enhance absorption, provide drug stability, and help overcome the challenges of poorly soluble APIs, enabling their formulation and development. During the pre-formulation stage, sound characterization analysis to determine the physicochemical properties of the API and excipients is critical to ensure that drug properties are maintained at all times. This helps identify drug formulation options and develop superior drug delivery systems to support drug stability and efficacy.

API and Excipient Screening Services

CD Formulation can help find, screen, purchase, and test APIs and excipients to ensure your drug is effective and delivered to market on time.

API Characterization Services

API characterization is the process of evaluating and defining the physicochemical and biological properties of active pharmaceutical ingredients (APIs). This may include identifying the chemical structure of the API and testing the API for purity, solubility, particle size, stability, flowability, and biological activity. CD Formulation offers a wide range of API characterization and testing services to support the development of your pharmaceutical products.

List of available services for APIs characterization:

Excipients Characterization Services

Excipients are inactive ingredients added to pharmaceutical formulations to improve the stability, bioavailability and other properties of the active pharmaceutical ingredients and can include fillers, binders, lubricants, preservatives, colorants, and flavoring agents and other substances. CD Formulation offers a wide range of excipient characterization and testing services to support the development of your pharmaceutical products.

List of available services for excipients characterization:

• Physicochemical characterization: Includes analysis of the physical and chemical properties of excipients, such as particle size, surface area, morphology, density, melting point, solubility and chemical composition.

• Microscope
• Spectroscopy
• Thermal analysis
• Chromatography

• Mechanical property testing: Testing of excipients such as binders and fillers that should have appropriate mechanical properties to ensure proper tablet or capsule formation, including characterizing the compressibility, compactibility, and flow characteristics of the excipients.

• Powder rheometry
• Hardness determination

• Hygroscopicity and stability testing: Test the hygroscopic behavior of excipients to ensure stability during storage and use.

• Dynamic vapor adsorption test
• Humidity control stability test

• Toxicity and safety assessment: Evaluate the potential toxicity, allergy, and safety of excipients.

• In vitro and in vivo studies

• API-excipient compatibility: Test the compatibility of excipients with the active pharmaceutical ingredient (API) and other ingredients in the formulation to ensure stability and efficacy.

• Differential scanning calorimetry,
• Fourier transform infrared spectroscopy
• X-ray diffraction

Why Choose CD Formulation?

• Fully integrated products to support the development of innovative delivery systems.
• Long-standing expertise in API and excipient characterization supports finding, screening, testing, and customizing APIs to suit your needs.
• Advanced technology and cutting-edge equipment support the characterization of a wide range of ingredients, allowing for quick turnaround.
• Fast and efficient internal general method, no need to start from scratch, saving time and cost.

At CD Formulation, we focus on partnership with our customers, understanding their needs and providing customized solutions. We are committed to continuously improving our technology and services to ensure we remain at the forefront of the industry. Please contact us to learn more about our services and how to get started.