Stability Studies

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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.

Stability Conditions

Analytical >> Stability Studies >> Overview

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.

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.

ICH Stability Studies/Degradation Studies

Analytical >> Stability Studies >> Overview

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 Compliant Stability Studies (Storage & Testing)

Analytical >> Stability Studies >> Overview

Our experienced team are here to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards.

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.

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.

ICH Stability Testing of Drug Products

Analytical >> Stability Studies >> Overview

We offer a full stability storage and testing service that satisfies ICH guidelines for the stability assessment of your drug products.

Accelerated & Forced Degradation Studies

Analytical >> Stability Studies >> Overview

Our team has carried out FDS not only within the development of new methods, we have also designed and performed FDSs within a GMP validation of methods in cooperation with the department of pharmaceutical analysis.

Stress Testing Studies

Analytical >> Stability Studies >> Overview

Forced degradation is a degradation of new drug substance and 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.