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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.

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's 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 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.

Stability Studies/Forced Degradation Studies

Analytical >> Stability Studies >> Overview

Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

Stability Studies for Bulk APIs & Formulations

Analytical >> Stability Studies >> Overview

ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

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.

Stability Testing

Analytical >> Stability Studies >> Overview

With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Other services are stability testing by capillary electrophoresis services. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Recently, the International Conference on Harmonisation (ICH) regulatory guideline QIA was revised (R2) when QIF “Stability Data Package for Registration Applications in Climatic Zones III and IV” was incorporated. The main changes included: Adjustment of intermediate storage conditions (previously 30°C ± 2°/60% RH ± 5%); acceptable relative humidity was changed to 65% ± 5% for drug substances, drug products and drug products packaged in semi-permeable containers, 30°C ± 2°/65% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/60% RH ± 5% for drug substances and products, 30°C ± 2°/35% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/40% RH ± 5% for drug products packaged in semi-permeable containers. Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of environmental and processing factors. Whether testing is conducted in-house or through contact laboratories, it involves the development and performance of comprehensive and specific stability protocols for all stages of a product’s life cycle. Testing product stability in-house requires significant time and resources, and carries challenges associated with commercialization market, time, and capacity. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. GMP Stability Services include cGMP registration stability programs, Design, storage and management, Development and validation of stability indicating methods, Stability testing for APIs, Clinical Trial Materials, formulated products, Tailored reporting (timepoint and final reports), All ICH conditions storage, Photostability (ICH Q1B Options 1 & 2), Temperature cycling, freeze-thaw and shipping studies, Bespoke or specialised conditions,Stability contingency and disaster recovery storage etc. Depending upon the aim and steps followed, stability testing procedures have been categorized into the following four types: Real-Time stability testing, Accelerated stability testing, Retained sample stability testing and Retained sample stability testing. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc.