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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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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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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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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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Photostability Studies

Analytical >> Stability Studies >> Photostability

Is the drug substance/product sensitive to light? Is this impact acceptable ? Are precautionary measures needed in manufacturing? Is a light resistant packaging mandatory? For all those questions, CEBIPHAR provides its support from protocol up to analyses.

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ICH-Compliant Stability Studies

Analytical >> Stability Studies >> Overview

Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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Qualified ICH Climatic Chambers with Recording Systems

Analytical >> Stability Studies >> Overview

Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

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Chemical & Physical Stability of Polymorphs

Analytical >> Stability Studies >> Overview

We help in stereochemical stability, chemical and physical stability of polymorphs, and structure elucidation based on LC/MS and chemistry.

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