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API Development

Analytical Method Development

Analytical Testing Services

Biologic Drugs

Biologics, Bioprocess & Fermentation

Container Closure Integrity

Container Qualification

Continuous Flow Process

Controlled Substance

Custom Synthesis & Manufacturing

Extractables and Leachables

Fine Chemical / Intermediate

Formulation Development

GMP Manufacturing

Halogenation

Hazardous Chemistry

High Potency APIs (HPAPIs)

Injectable / Sterile APIs

Liposome / Microsphere / Nanoparticle

Liquid

Organometallic Chemistry

Packaging and Distribution Testing

Preformulation & Material Science

Protein / Peptide

Small Scale Batch

Solution

Suspension

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AMRI

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UNITED STATES

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Retains & Complaint Resolution

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In accordance with CFR 21 Part 211.170 – Production Retains Storage and Complaint Handling, AMRI provides storage of reserve samples.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Retains and Complaint Resolution

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Package Integrity

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AMRI provides complete package integrity testing services in accordance with regulatory guidances.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Package Integrity Testing

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Expertise in Continuous Flow Chemistry

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Our continuous flow processing capabilities offer unique advantages compared with batch processes, resulting in faster, safer and more robust material production with higher selectivity of desired products.

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Pharma Service: API Manufacturing

Category: Continuous Flow Process

Sub Category: Overview

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Extensive Chemical and Technical Expertise

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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cGMP API Manufacturing

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AMRI offers cGMP manufacturing of your API in small scale and in production scale. AMRI handles small-scale API production critical for discovery and development, GMP scale in Albany and manufacturing at our global API facilities.

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Pharma Service: API Manufacturing

Category: GMP Manufacturing

Sub Category: Overview

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Achieve Superior Quality With Less Waste

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Certified by SafeBridge®, AMRI's facilities provide the most advanced technology for the production and safe containment of your compound.

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Pharma Service: API Manufacturing

Category: High Potency APIs (HPAPIs)

Sub Category: Overview

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Custom Synthesis and Contract Manufacturing

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AMRI provides custom synthesis and contract manufacturing services at small and large scale for all phases of discovery, development and manufacturing. Our teams bring extensive chemical and technical expertise to develop flexible for your needs.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Overview

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Complex APIs using Fermentation

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AMRI is one of the leading producers of complex APIs using fermentation. We offer comprehensive biocatalysis capabilities, including rapid biocatalytic screening and evaluation, and process development & optimization at both pilot and commercial-scale.

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Pharma Service: API Manufacturing

Category: Biologics, Bioprocess & Fermentation

Sub Category: Overview

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DEA Controlled Compounds

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AMRI is your trusted partner, providing expert solutions for the safe, secure development and manufacture of controlled substances.

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Pharma Service: API Manufacturing

Category: Controlled Substance

Sub Category: Overview

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Liquid Formulation Development Capabilities

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AMRI offers specialized aseptic formulation development and manufacture of small batches for early-stage clinical trials.

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Pharma Service: Drug Product Manufacturing

Category: Liquid

Sub Category: Clinical Supply

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Protein / Peptide Development Capabilities

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AMRI offers expertise and capabilities to manufacture proteins and peptides.

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: Protein / Peptide

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Monoclonal Antibody Development Capabilities

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AMRI offers expertise and capabilities to manufacture monoclonal antibodies.

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: Monoclonal Antibody

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Topical And Intravitreal Ophthalmic Products

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AMRI offers GMP manufacturing and expertise in final dosage forms for topical and intravitreal ophthalmic products, including standard bottles, sterile multi-use bottles and prefilled syringes or vials.

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Pharma Service: Drug Product Manufacturing

Category: Solution

Sub Category: Ophthalmic

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Characterizing & Modifying Drug Substances

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With expertise in characterizing and modifying a drug substances' physical, chemical and mechanical properties, our objective is to help you assess and choose the best solid form for progression into animal and human dosing trials.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Overview

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Separations Sciences

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AMRI's expert scientists routinely isolate materials of interest, including controlled substances and potent compounds, through classic and chromatographic techniques.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Separation & Purification

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Chemical Purification

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AMRI’s inventory of chromatography media for preparative applications (chiral and achiral) provides extensive screening options as well as quicker turnaround on the processes.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Separation & Purification

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Impurity Isolation and Identification

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AMRI's scientists apply LC/MS as a profiling technique to systematically monitor process-related impurities and degradants.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Fine Chemicals

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To accelerate your efforts in discovery and development, AMRI offers a fine chemicals catalog with more than 700 compounds.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

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Small-Scale Manufacturing Platform

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Strengths of AMRI's small-scale manufacturing platform include clinical API manufacturing and clinical drug product manufacturing up to 10kg, including oral drug products and sterile fill and finish.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Scale-Up Capabilities

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Chemical Development

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AMRI’s team of scientists supports all your chemical development needs, offering integrated, continuous service through the drug development life cycle.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

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Fermentation, Biocatalysis and Bioprocesses

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AMRI offers extensive expertise, facilities, experience and execution for assessing, developing, and implementing API syntheses that benefit from fermentation, biocatalysis, synthetic biology, and related approaches.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Biocatalysis

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Organometallic Chemistry Capabilities

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Our scientists bring more than 15 years of experience in the field of organometallic chemistry and a global infrastructure to deliver a wide range of high-quality compounds at large scale.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Organometallic Chemistry

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Drug Product Development Capabilities

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AMRI offers specialized aseptic formulation development and manufacture of small batches for early-stage clinical trials.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Clinical Supply

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Controlled Substance Drug Product Development

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AMRI provides extensive technical expertise in the development, scale-up and GMP manufacture of liquid and lyophilized sterile dosage form products and offers solutions for a variety of compound categories, such as small and large molecules and controlled

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Controlled Substance

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Range of Sterile Lyophilization Techniques

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AMRI offers a range of sterile lyophilization techniques at preclinical to clinical scale while using commercial-grade redundant components.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Lyophilization

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Cocrystal Screening

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Comprehensive cocrystal screen and ongoing support for selection

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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Enantiomeric Resolution

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Resolution of enantiomers through crystallization is often a preferred option, favored over costly preparative chromatography during process development and manufacturing. AMRI has the experience to solve your most complex resolution problems through crys

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Chiral Resolution Screening

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Physicochemical & Biopharmaceutical Testing

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AMRI provides a complete suite of state-of-the-art instrumentation and techniques to characterize physicochemical and biopharmaceutical properties. We will identify appropriate experimentation & interpret results for the selection of suitable forms.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Customized Stability & Release Testing

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AMRI offers customized stability testing that includes developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Production of Hazardous Chemistries

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AMRI's scientists have mastered the efficient production of APIs and intermediates using a broad range of hazardous chemistries.

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Pharma Service: API Manufacturing

Category: Hazardous Chemistry

Sub Category: Overview

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Oral Drug Products & Sterile Fill & Finish

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Strengths of AMRI's small-scale manufacturing platform include clinical API manufacturing and clinical drug product manufacturing up to 10kg, including oral drug products and sterile fill and finish.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Scale-Up Capabilities

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Process Analytical Technology

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AMRI's Process Analytical Technology (PAT) approach is consistent with the FDA perspective that quality cannot be tested into products, but should be built in.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science >> Overview, Overview

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Crystallization Process Development

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AMRI's dedicated group of crystallization experts has a legacy of success in particle engineering and technology transfer.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Crystallization Process

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Formulation Services

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AMRI's scientists provide support and direction to design robust formulations for preclinical and clinical use.

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Pharma Service: API & Drug Product Development

Category: Formulation Development

Sub Category: Overview

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Chromatographic Expertise & Techniques

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To analyze your compounds, we offer a variety of chromatographic expertise and techniques like HPLC and UPLC/UHPLC instrumentation with a wide variety of detection capabilities (UV, DAD, RI, MS, MALS).

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

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Diffraction Studies

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AMRI has extensive experience in the interpretation of powder diffraction patterns and have developed unique methodologies for fully automated recognition of crystalline forms.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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Gas Testing Protocols & Validation Reports

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AMRI's quality assurance team works with you to develop gas testing protocols and validation reports to ensure your company meets FDA requirements for medical/process gas usage.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Gas Testing

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Heavy Metals Testing

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AMRI has the capability to perform USP <232> and USP <233> testing, including heavy metals testing and testing on drug substances, excipients, drug products and dietary supplements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Trace / Elemental / Heavy Metals

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Mass Spectrometry

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We provide ultra-high resolution mass spectrometry with our industry-leading expertise, the resulting data and scientific interpretation are unmatched in the contract preclinical research industry for large and small molecule analyse

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Mass spectrometry and LC / MS

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Material Testing

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AMRI offers comprehensive USP-NF, EP, FCC and JP monograph testing for many raw materials used in pharmaceutical products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Complete Pharmacopoeial / Compendial Testing

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Micromeritics

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AMRI offers micromeritics capabilities, including fit-for-purpose method development and routine analytical services

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Microscopical Studies

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AMRI routinely uses results from microscopy studies to complement analytical data from other techniques to address your solid state characterization issues.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Light Microscopy

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Residual Solvents

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AMRI's analysts possess more than two decades of experience analyzing pharmaceutical products for residual solvents and can test products at any stage of development (raw materials, intermediate products and final products).

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Residual Solvents

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Sorption & Desorption

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AMRI's experts investigate the moisture uptake of samples at various relative humidities and temperatures using moisture sorption balances and/or gravimetric methods, and we can fully characterize any new forms observed.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Sorption and Desorption

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Water Analysis

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AMRI uses various techniques to provide information on water content, hygroscopicity and hydrate formation.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Karl Fischer / Water Analysis

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Thermal Analysis & Calorimetry

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AMRI monitors thermochemical events and weight loss as a function of temperature to achieve insight into solid form characteristics, mechanisms of polymorphic transformations and solid state degradation pathways.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: DSC

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Batch Release & Stability Lot Testing

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AMRI provides the resources and flexibility to develop and improve analytical methods tailored to your specific needs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Batch Release and Stability Lot Testing

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Stability, Solubility, Dissolution

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AMRI's industry-leading scientists conduct preclinical and clinical stability studies on drug substance and drug products through our full-service solid state and chromatography/dissolution groups.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Dissolution

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Mapping & Imaging Studies

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AMRI's powerful analytical techniques provide a wealth of chemical and physical information on specific microscopic regions of solid samples.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: FTIR / NIR

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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

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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

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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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Container Closure Integrity

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AMRI's container closure integrity experts provide accurate, sensitive and reliable data for definitive container closure integrity verification, especially for packages that demand the highest degree of product protection.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Assessment Programs

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Vacuum Decay Leak Detection

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AMRI conducts all standard vacuum decay tests in accordance with ASTM F2338-09.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Vacuum Decay Leak Detection

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Electrical Conductivity / High Voltage Leak

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AMRI conducts electrical conductivity / high voltage leak detection (HVLD) testing on a range of package systems, including parenteral vials, prefilled cartridges and syringes, plastic containers and plastic bags or pouches.

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Helium Leak Detection (HeLD)

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AMRI uses helium mass spectrometry to measure the package and seal integrity of nonporous packaging such as vials, syringes and cartridges.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Helium Leak Detection (HeLD)

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Residual Seal Force (RSF)

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AMRI's expert team offers parenteral vial capping and residual seal force (RSF) testing of parenteral package systems.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Residual Seal Force (RSF)

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Mass Flow / Mass Extraction Leak Detection

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- Service Details

AMRI's CCIT specialists can perform mass extraction testing on any package containing headspace, including parenteral vial packages, screw-capped bottles and flexible bags or pouches.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Mass Flow / Mass Extraction Leak Detection

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Laser-Based Headspace Analysis

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AMRI can assess your package’s headspace via laser-based analysis techniques

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Laser-Based Headspace Analysis

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Airborne Ultrasound / Seal-Scan

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- Service Details

AMRI's container closure integrity experts perform seal-scan testing to identify defects such as inconsistent seals and areas of the seal in which the minimum seal width requirement is not met.

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Pharma Service: Analytical

Category: Container Closure Integrity

Sub Category: Airborne Ultrasound / Seal-Scan

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Pharmaceutical Glass

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To ensure you meet USP regulations regarding testing containers, AMRI provides testing for various classes of pharmaceutical glass.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Pharmaceutical Glass

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Plastic Containers

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- Service Details

To qualify your plastic container for use with pharmaceutical-based products, AMRI provids specialized testing procedures based upon the specific type of plastic that the container is made from.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Plastic Containers

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Auxiliary Packaging Components

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AMRI provides testing for auxiliary packaging components in accordance with all requirements and revisions to current USP chapters.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Auxiliary Packaging Components

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Container Performance

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- Service Details

AMRI's experts provide a range of services that assess the container performance of your solid and liquid dose products.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Container Performance

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EP & Japanese Pharmacopoeia Container Testing

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- Service Details

AMRI provides container qualification testing in accordance with European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) regulations.

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Elastomeric Closures

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AMRI conducts testing on elastomeric closures to determine the sterility of sterile product packaging.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Elastomeric Closures

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Biological Reactivity

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AMRI provides testing to determine the biological reactivity in vitro and in vivo of your plastic container components.

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Biological Reactivity

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Container Qualification Full Test List

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- Service Details

AMRI offers comprehensive routine Pharmacopoeial container qualification testing

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Pharma Service: Analytical

Category: Container Qualification

Sub Category: Testing Services

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ASTM & ISTA Distribution Simulation Testing

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- Service Details

AMRI's package testing laboratory provides drop (shock), random vibration, loose load vibration and compression testing — all performed on the most modern, industry-recognized equipment from Lansmont Corporation.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: ASTM and ISTA Distribution Simulation Testing

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Environmental Conditioning & Cycling

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- Service Details

AMRI employs high-performance Cincinnati Sub-Zero environmental chambers to provide Environmental Conditioning, Cycling and Simulation Testing, accelerated aging and real-time storage programs to pharmaceutical/biotechnology manufacturers.

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Pharmaceutical Package Testing

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- Service Details

AMRI's cGMP, FDA-registered and ISO 17025-accredited laboratories provide integrated services for primary container and packaging performance testing for the world’s leading pharmaceutical and biotech manufacturers.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Pharmaceutical Package Testing

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Medical Device Packaging Testing

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- Service Details

AMRI's ISTA and ISO 17025-certified package testing laboratory provides medical device package validation testing in accordance with ISO 11607, the principle guidance for validating terminally sterilized medical device packaging.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Medical Device Packaging Testing

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Consumer Product Packaging

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AMRI offers complete consumer product packaging test programs.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Consumer Product Packaging

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Shelf Life & Accelerated Aging Testing

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- Service Details

AMRI performs accelerated aging (AA) on materials, products and packaging systems, including packaged medical devices, to provide a lens into real-time shelf life.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Shelf Life and Accelerated Aging Testing

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Packaging Materials

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- Service Details

AMRI offers a wide variety of options for testing the physical and chemical properties of packaging materials

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Packaging Materials Testing

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Package Labeling

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- Service Details

AMRI can evaluate your pharmaceutical and medical device product labels for legibility and adhesion properties through temperature and humidity exposure of applied labels, peel resistance and abrasion resistance.

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Package Strength

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AMRI offers a wide variety of testing options for package strength testing.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Package Strength Testing

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Bacterial Endotoxin Testing: USP <85>

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To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection and APIs, AMRI's experts offer testing for the detection and control of endotoxins.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Antimicrobial Effectiveness Testing (AET)

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AMRI performs antimicrobial effectiveness testing (AET) or preservative effectiveness testing to help evaluate your product’s ability to withstand microbial contamination during use.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Microbiological Population Verification

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AMRI provides microbiological population verification services through the assessment of biological indicators per USP <55>.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

Virtual BoothA partner for the pharma and biotech industries to improve patient outcomes & quality of life

Environmental Monitoring

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AMRI provides environmental monitoring services to evaluate your cleaning and disinfection programs, assessing the microbial cleanliness of your manufacturing environment per USP <1116> Microbiological Evaluation of Clean Rooms

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: