Nitto Avecia Pharma Services
Analytical Chemistry

Services

Analytical Chemistry

We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing.

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Analytical Development

Our analytical development group has experience in support of various dosage forms within the generic and branded pharmaceutical industries. The team's diverse background has enabled Avecia Pharma to develop an in-depth understanding of all facets of the drug development process.

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Parenteral Manufacturing

Avecia Pharma's manufacturing department produces batches at the highest quality as the team works hand-in-hand with the Formulation and Quality teams as well as other resources to develop the documentation, process flow, material list and equipment recipes needed in the successful transfer from a lab environment into manufacturing.

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Biopharmaceutical Development

From proof-of-concept to commercialization, depend on the scientific strength of Avecia Pharma. We offer reliable technical expertise, rigorous quality systems, state-of-the-art instrumentation, and thorough experience working with a range of biomolecules.

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Drug Delivery Technologies

We combine our core competencies in drug delivery technologies' development with an ongoing commitment to state-of-the-art instrumentation and technology. Additionally, we provide an innovative approach to cross-functional scientific expertise and experience, high quality systems, and above-and-beyond project management.

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Formulation Development

Avecia Pharma's pre-formulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Our formulation experts unite a thorough understanding of your needs along with the data on the physicochemical properties of the compounds to ensure the delivery of a stable, high quality product.

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Microbiology

As the demand for precision and timeliness microbiological data rises, trust Avecia Pharma to deliver. We offer extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to dedicated project management and high quality reporting ensure the timeliness your projects demand.

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Stability

For the quality control and security your projects demand, all cGMP validated environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Our walk-in, reach-in, UV/visible and fluorescent photostability chambers are supported by back-up chambers, a reserve generator and an electronic notification system.

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Structural Chemistry

Avecia Pharma's integrated team approach unites our structural chemists with scientists from other departments to provide a comprehensive set of capabilities and expertise that will efficiently accelerate and strengthen the process of characterizing and identifying complex chemical and protein compounds.

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Industry Updates

Residual Solvents

Our USP/ICH compliant, state-of-the-art laboratory and experienced team of scientists allow you to manage the large number of methods that may be involved in identification and quantification of impurities, including residual solvents.

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Extractables/Leachables

Regulations make extractables and leachables studies an essential part of your development process. Our team of skilled scientists is highly experienced in developing and validating new methodologies in support of various container/closure systems.

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Elemental Impurities

In an effort to improve and modernize the USP General Chapter for Heavy Metals <231>, USP has proposed the addition of two new General Chapters and one Supplemental General Chapter.

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