Pharmaceutical ingredients include active pharmaceutical ingredients (APIs) and inactive ingredients or excipients. Excipient and API testing is an important process in the pharmaceutical industry to ensure the quality, safety and efficacy of drugs.
Protheragen Lab offers comprehensive excipient and API testing services to the pharmaceutical industry. Our state-of-the-art laboratory and experienced team of experts ensure that your drug formulations meet the highest standards of quality, safety, and efficacy. With a focus on regulatory compliance and adherence to compendial requirements, we provide accurate and reliable testing results for excipients and APIs.
Understanding excipients and APIs
- An API is the component of a pharmaceutical drug that produces the intended therapeutic effect. It is the active substance responsible for treating, curing, or preventing a disease or medical condition. APIs can be synthetic or derived from natural sources.
- Excipients are the inactive substances or components present in a drug formulation. They are used alongside the API to enhance stability, facilitate drug delivery, improve palatability, and provide other desirable characteristics to the final drug product. Excipients can include fillers, binders, disintegrants, lubricants, preservatives, colorants, and flavoring agents, among others.
Excipient and API Testing Programs Available
We mainly provide you with the following pharmaceutical excipient and API testing programs.
Compendial Method Verification and Validation Studies
- We perform compendial method verification and validation studies to ensure that the analytical procedures used in the testing of excipients and APIs are accurate, specific, and reliable.
- Our skilled scientists meticulously verify and validate compendial methods, ensuring that they meet the specific requirements of your drug formulation.
- By conducting method verification and validation studies, we ensure that the analytical methods employed deliver consistent and reproducible results.
Monograph Release Testing
- Our laboratory conducts monograph release testing in accordance with the guidelines set forth by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), and Japanese Pharmacopoeia (JP).
- We rigorously evaluate excipients and APIs to ensure compliance with the monograph specifications, verifying their identity, purity, potency, and other critical attributes.
- Our comprehensive monograph release testing services provide you with the necessary data to support regulatory submissions and ensure the quality and safety of your drug products.
Additional Services
In addition to the core services mentioned above, we offer a range of supplementary testing and analytical services to support your excipient and API development process:
- Physicochemical characterization of excipients: Particle size, bulk density, flowability, moisture content, melting point, pH, solubility, and other physicochemical attributes of excipients are evaluated to ascertain their suitability for specific drug formulations.
- Compatibility studies: We conduct compatibility studies to assess the potential interactions between excipients and APIs, as well as with packaging materials, ensuring the stability and integrity of the final drug product.
- Impurity profiling: Our advanced analytical techniques enable the identification and quantification of impurities in APIs and excipients, including related substances, residual solvents, and degradation products.
- Stability testing: We offer comprehensive stability testing services to assess the shelf life, degradation pathways, and storage conditions of your drug formulations, ensuring their quality throughout their intended shelf life.
Why Choose Protheragen Lab?
- State-of-the-art laboratory facilities equipped with advanced analytical instruments
- Experienced team of scientists and experts with extensive knowledge of excipient and API testing
- Compliance with regulatory requirements and compendial standards
- Accurate and reliable testing results with quick turnaround times
- Customized testing approaches tailored to your specific needs
- Confidentiality and data security ensured throughout the testing process
- Cost-effective solutions without compromising on quality
Contact us today to discuss your testing requirements and benefit from our expertise in pharmaceutical analysis and quality assurance.