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Chemical Characterization
Impurities
Impurity Isolation and Identification
Testing Services
Toxicological Risk Assessment (TRA)
AMRI
Aizant Drug Research Solutions Pvt. Ltd.
Anacipher
Boston Analytical
Cambrex Corporation
Crenza Pharma
Curida AS
DPT Laboratories, Ltd
GRAM Laboratory Inc
Megsan Labs Private Limited
Pace Analytical Services, LLC
Primera Analytical Solutions Corp
Quantex Laboratories
Recipharm AB
Saneca Pharmaceuticals
Unither Pharmaceuticals
Vitas Analytical Services
West pharma services
mKnal Global Solutions
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A partner for the pharma and biotech industries to improve patient outcomes & quality of life
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AMRI's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Chemical Characterization
- Service Details
Unither analytical services include method development & validation, analytical method transfer & ICH stability studies. They provide extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Impurity Isolation and Identification
Brightest Minds in the CDMO industry - From early Development to Commercial Manufacturing
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Recipharm has extensive experience and a range of analytical and synthetic equipment to conduct successful impurity identification in pharmaceutical products.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Impurity Isolation and Identification
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West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
A partner for the pharma and biotech industries to improve patient outcomes & quality of life
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AMRI offers extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process, including single use systems (SUS), final container/closure, drug delivery devices & overall packaging configuration of your product.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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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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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
A partner for the pharma and biotech industries to improve patient outcomes & quality of life
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AMRI's experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Impurities
A partner for the pharma and biotech industries to improve patient outcomes & quality of life
- Service Details
AMRI offers toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Toxicological Risk Assessment (TRA)
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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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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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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Toxicological Risk Assessment (TRA)
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Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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At Saneca Pharma, we offer a range of generic API development services including route of synthesis optimisation. Our API development & manufacturing facilities use the same equipment to take your project from pilot to commercial scale production.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Impurity Isolation and Identification
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Physical and physio-chemical determinations (e.g. pH,nconductivity, viscosity, melting point, refractometer, polarimeter, sub-visible particle counter, osmolality, loss on drying)
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Chemical Characterization
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Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Testing Services
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We offer Integrating Capabilities of Building product safety into process design under one roof, which can facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitgating risks associated with the final product.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Chemical Characterization
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DPT’s provides reliable and accurate analytical testing services for Impurities.
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Pharma Service: Analytical
Category: Extractables and LeachablesSub Category: Impurities
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