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Stability Studies

Analytical >> Stability Studies >> Overview

CEBIPHAR provides its support from the study design up to analyses: Protocol design and optimization, Sophisticated ICH storage platform, Regulatory compliance, Multi-disciplinary teams: physico-chemical, pharmaco-technical, and microbiological analyses.

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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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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 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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Stress Testing Studies

Analytical >> Stability Studies >> Overview

Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways.

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Stress and Stability Programs

Analytical >> Stability Studies >> Overview

ChemCon carries out ICH-compliant stress and stability programs.

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SAXS for Stability Studies

Analytical >> Stability Studies >> Overview

Information about the structural parameters obtained from the SAXS measurements, such as envelope shape and invariants (mass and radius of gyration), serve as important markers that are correlated with biological activity.

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Full ICH Stability Conditions

Analytical >> Stability Studies >> Overview

UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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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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