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Liposome Testing and Characterization of Complex Generics Laboratory

Liposomes are spherical engineered particles made of phospholipids used in the pharmaceutical and cosmetic industries as well. Characterization of complex generics and analysis to support drug development is an expectation for myriad products where the drug substance is said to be encapsulated in a liposomal structure.

The regulatory expectation of a liposomal drug specification in a Liposome testing and characterization laboratory includes a variable range of parameters, including a thorough analysis of all components, including the lipids, the free drug, encapsulated drug, and other processes impurities.

Thus, our team has expertise in study design and the development and validation of methods that are specifically tailored to your liposome drug product characteristics. Do get in touch with us today.

We are an experienced team serving with experience & extensive capabilities for characterization of complex generics product development in association with Indian companies and US based collaborators. Our team is highly experienced in turn-key assignment execution in a liposome testing and characterization laboratory, proof of concept development, IPR generation, technology transfer including Carbohydrate based Nano Pharmaceuticals Iron sucrose, polymeric nanoparticles, micro suspensions, micelles, inhalation products, transdermal systems and other complex drug products falls within our activity domain where we are experienced to serve multiple MNCs.

Comprehensive Guide to USP 1790 Compliance -

USP 1790 Compliance is a set of regulations put in place to ensure that the United States Pharmacopeia (USP) remains the authoritative resource on drug substances, dosage forms, and quality standards. The goal of this USP is to protect patients by ensuring that only safe and effective drugs are made available to them

To achieve this USP, manufacturers and distributors of drug substances must adhere to several requirements, including quality management systems, process validation, and good manufacturing practices (GMPs). In addition, they must submit regular reports to the USP detailing their compliance.

It is the term used to describe the specific regulatory requirements that apply to the storage and handling of hazardous materials. The phrase is most often used about the transportation of hazardous materials, but it can also apply to storage and handling procedures.

Consequences of Not Complying with USP 1790 Compliance -

Noncompliance with USP 1790 Compliance can result in a number of negative consequences, including fines, imprisonment, and even loss of business licenses.

Aforesaid We described the development and characterization of a liposome testing and characterization laboratory. Liposomes are spherical vesicles that are used to deliver drugs and other therapeutic agents & it also provides an overview of this USP and the standards that it encompasses. It is a comprehensive resource that will help you to understand the requirements and how to meet them. If you have any questions or need more information, you may connect with our team of specialists, we would be happy to answer any of your questions