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ICH Compliant Stability Control

Analytical >> Stability Studies >> Overview

A wide range of ICH conditions of walk in/reach in chambers, refrigerated and freezer storages which are fully controlled and monitored. 24 hour alarm system is on site, along with a dedicated team trained to respond to any deviations from the set storage conditions.

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Stability Conditions

Analytical >> Stability Studies >> Overview

Angelini Fine Chemicals - Your GMP “One-Stop-Shop”, Angelini Fine Chemicals is a Contract Development and Manufacturing Organization (CDMO), which is fully dedicated to third party manufacturing of APIs, IMs and NCEs for the pharmaceutical and small molecule biotech industry.

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Stability Studies for Custom APIs

Analytical >> Stability Studies >> Overview

Pfizer's commercial manufacturing capabilities span the requirements of it’s global small-molecule portfolio, and we put those resources to work for you to. They are able to perform both traditional and highly specialized processes.

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Stability Studies

Analytical >> Stability Studies >> Overview

We provide a full custom manufacturing service to customers looking for a flexible and qualified partner able to produce parenterals in accordance with their specifications. In addition, we provide services - stability studies.

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Walk-in type Stability Chamber

Analytical >> Stability Studies >> Overview

Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

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Stability Testing and Storage

Analytical >> Stability Studies >> Overview

With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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Stability Studies

Analytical >> Stability Studies >> Overview

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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ICH-Compliant Stability Studies

Analytical >> Stability Studies >> Overview

Each of our plants has qualified in-house climate chambers and can do ICH-compliant stability studies, using carefully set conditions depending on product characteristics, regulatory requirements and the desired shelf life.

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ICH Stability Studies

Analytical >> Stability Studies >> Overview

We perform ICH stability studies on drug substance and /or dosage form. Studies are conducted according to the Stability Study Protocols and fully under GMP conditions.

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Stability Storage For all key ICH climatic zones

Analytical >> Stability Studies >> Overview

Offering stability storage for all key ICH climatic zones. Our available conditions and storage solutions are suitable for long term, intermediate, accelerated, photo-stability, in-use and FUST stability trials.

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