Analytical Methodology Research Services

CD Formulation is dedicated to the development of services for pharmaceutical formulations, including physicochemical property testing, impurity testing, biological testing, stability analysis, etc. However, the development of these test methods requires validation, and only after validation can we guarantee reliable, accurate and precise test results. In our company, we can provide you with not only the development of various testing technologies and methods, but also the validation of these technologies and methods to accelerate your drug development and commercialization process.

Background

Method validation for drug testing includes verifying the precision, accuracy, detection limit and system applicability of the developed method. The validation requirements vary depending on the purpose of the test, and only validated analytical methods can be used for analytical testing in drug production. In order to ensure that the analytical test results are correct and credible, the correctness, scientificity and feasibility of the analytical methods used must be verified to prove that The analytical method meets the purpose and requirements of the test.

Our Services

CD Formulation provides method development and method validation services, including method development trial design, process reports, validation methods and validation reports, analytical assays for APIs and drug formulations for stability content studies or related substances, a wide range of chromatographic (HPLC, UPLC, GC, IC), spectroscopic (ICP, AAS, AS, AFS) and detection techniques (UV, MS, IR, FID, ECD, etc.) to meet different types of services.

Services contents

• Method Development & Method Validation for Solubility and Dissolution Curves
• Method Development & Method Validation for Related Substance and Assay
• Forced Degradation Studies
• Method Development and Method Validation for Particle Size
• Microbial Assay Method Development and Method Validation
• Genotoxic Impurity Method Development and Methodological Validation

In addition to the above-mentioned services, you can also ask us for consulting services that are not on our list. Since our business is constantly updated, we can customize the relevant services to meet your requirements.

Service Advantages

Highly qualified and guaranteed

Qualified as an inspection and testing organization, and in strict accordance with the provisions of the construction and management of R & D laboratories, instrumentation laboratories and other professional laboratories

Advanced instruments

The laboratory has a large number of precision testing instruments and various types of professional analytical equipment to meet the customer's testing of drug quality. The instruments and equipment enable management of experimental data, real-time audit tracing, and traceability of data results to ensure the accuracy of testing data.

Full services

We focus on R&D, testing and other services. Always customer-centric, constantly improve the comprehensive service capabilities, dedicated to serving the global field of research and analysis, testing platform.

Short cycle time

We usually work one-on-one and have a full range of integrated services, from API to drug formulation development, testing, method validation to process optimization, which greatly shortens the process of drug development for our customers.

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