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Forced Degradation Studies & Stress Tests

Analytical >> Stability Studies >> Photostability

Dishman strives to provide a comprehensive portfolio of analytical services to facilitate this work. Analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

ICH Stability Testing, Including Photo Stability

Analytical >> Stability Studies >> Photostability

To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

Forced Degradation Studies & Stress Tests

Analytical >> Stability Studies >> Photostability

At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.

Photostability Studies

Analytical >> Stability Studies >> Photostability

Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

Photo Stability Studies

Analytical >> Stability Studies >> Photostability

Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

Photostability Studies

Analytical >> Stability Studies >> Photostability

Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

Photostability and In-use stability

Analytical >> Stability Studies >> Photostability

The R&D Department is staffed with fully trained and highly experienced scientists and has at its disposal state-of-the-art facilities striving to produce products according to GMP/GLP global standards.

ICH Photostability

Analytical >> Stability Studies >> Photostability

Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

Photo stability (UV & Daylight) per ICH Q1B

Analytical >> Stability Studies >> Photostability

Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

Photostability Evaluation

Analytical >> Stability Studies >> Photostability

GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc. Analytical stability programs for a drug substance or drug product also can be used for the characterization of impurities and related substances in line with dissolution studies, and to residual solvents, disintegration, and friability. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and other storage conditions. cGMP stability analyses include ICH Stability Services, Real-Time & Long Term Stability, Accelerated Stability, Forced Degradation Studies, Stress Stability Testing, R&D Stability Testing, In-Use Studies, Photostability, Comparative/Comparator Stability, Follow Up Stability Testing (FUST), Formulation Evaluation Stability, Finished Product Release, Cycling Chamber Stability Studies etc.

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