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Chemical Characterization

Impurities

Impurity Isolation and Identification

Testing Services

Toxicological Risk Assessment (TRA)

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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

Saneca Pharmaceuticals

Unither Pharmaceuticals

Vitas Analytical Services

West pharma services

mKnal Global Solutions

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FRANCE

INDIA

NORWAY

SLOVAKIA (SLOVAK REPUBLIC)

UNITED STATES

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Chemical Characterization

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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 Leachables

Sub Category: Chemical Characterization

Virtual BoothUnither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Extractable & Leachable Compatibility Studies

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Unither analytical services include methods development & validation, analytical methods transfer, ICH stability studies with storage, extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc .

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Chemical Characterization

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Extractables & Leachables Testing For Deliver...

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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 Leachables

Sub Category: Testing Services

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Extractables & Leachables Testing Services

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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 Leachables

Sub Category: Testing Services

Virtual BoothUnither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Extractable & Leachable Closure System

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Unither analytical services include methods development & validation, analytical methods transfer, ICH stability studies with storage, extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc .

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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Assessment of Leachables & Extractables In Dr...

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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 Leachables

Sub Category: Testing Services

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Impurities

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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 Leachables

Sub Category: Impurities

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Toxicological Risk Assessment (TRA)

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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 Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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Extractable & Leachable Studies

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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 Leachables

Sub Category: Testing Services

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Extractable & Leachable Testing

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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 Leachables

Sub Category: Testing Services

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Assessment of Leachables & Extractables In Dr...

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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 Leachables

Sub Category: Testing Services

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Assessment of Leachables & Extractables In Dr...

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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 Leachables

Sub Category: Testing Services

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Extractable & Leachable Study

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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 Leachables

Sub Category: Testing Services

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Genotoxic Evaluation

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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 Leachables

Sub Category: Toxicological Risk Assessment (TRA)

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Extractable & Leachables

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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 Leachables

Sub Category: Testing Services

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Synthesising & Characterising Impurities

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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 Leachables

Sub Category: Impurity Isolation and Identification

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Physical & Physio-Chemical Determinations

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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 Leachables

Sub Category: Chemical Characterization

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Extractables & Leachables analysis

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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 Leachables

Sub Category: Testing Services

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Extractables & Leachables Study

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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 Leachables

Sub Category: Testing Services

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Leachables & Extractables Studies

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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 Leachables

Sub Category: Testing Services

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Extractable & Leachables

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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 Leachables

Sub Category: Testing Services

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Extractable & Leachable Studies

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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 Leachables

Sub Category: Testing Services

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Chemical Characterization

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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 Leachables

Sub Category: Chemical Characterization

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Impurities Testing

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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 Leachables

Sub Category: Impurities

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