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The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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AMRI

Aizant Drug Research Solutions Pvt. Ltd.

Anacipher

Boston Analytical

Crenza Pharma

DPT Laboratories, Ltd

Doctor's Analytical Laboratories

GRAM Laboratory Inc

Megsan Labs Private Limited

Pace Analytical Services, LLC

Primera Analytical Solutions Corp

Quantex Laboratories

Sartorius Stedim Biotech

Vitas Analytical Services

West pharma services

mKnal Global Solutions

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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

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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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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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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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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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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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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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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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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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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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Sartorius offers unique expertise in the field of extractables & leachables, such as extractables evaluation, extractables & safety assessments, E&L long-term/storage studies for different container materials, leachables screening, etc.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub 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 Leachables

Sub Category: Testing Services

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DALPL's current services at the pharma division include extractable & leachables as per FDA guidelines & PQRI suggestions, genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities by ICP MS, etc.

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Pharma Service: Analytical

Category: Extractables and Leachables

Sub Category: Testing Services

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