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Surface area and porosity are two important physical properties that determine the quality and utility of pharmaceutical materials. Differences in the surface area and porosity of particles within the material, which otherwise may have the same physical dimensions, can greatly influence its performance characteristics. Surface area and porosity play major roles in the purification, processing, blending, tableting and packaging of pharmaceutical products as well as the drug’s useful shelf life, its dissolution rate and bio-availability. In other healthcare applications such as regenerative medicine tissue scaffolds, controlling and optimizing the porosity of the scaffold material will help the tissue regrowth process. In analytical laboratories the use of materials with well-defined pore sizes and high surface areas are used in biochemical and pharmaceutical separation science. Understanding the physical properties of pharmaceutical solid materials is key to successful drug product and process development. These physical properties can have an impact on the material’s bulk properties, product performance, processability, stability and product appearance. The melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapour pressure, and density can all be affected. GLP, GCP or cGMP compliant physical characterization services assist with formulation or process development, regulatory submission data, QC testing, GMP lot release and manufacturing troubleshooting. Physical Characterization Testing Capabilities offered by Contraact Analytical service providers include: Calculation of BET surface area: single or multipoint; Determination of pore size and pore size distribution within 1.7 to 500 nm for macro, micro or mesoporous samples; Measurement of surface area as low as 0.001 m2 /g; Predicting reactivity, dissolution and compactness; Measurement of rate and ease of water permeation; Measurement of water vapor sorption - desorption isotherm; Measurement effect of sample environment on crystallinity or amorphous content; Determination changes in flow ability, compaction density and appearance; Determination phase and structural transition between -90 to 400°C; Directly measuring heat capacity; Analysis of complex and overlapping thermal changes - modulated DSC capable; Detection of weak thermal changes; Measurement of the change in sample mass as a function of temperature and/or time Monitoring moisture/Solvent loss [LOD on micro scale] Determination of rate of chemical degradation at various temperatures; Measurement of gas absorption-desorption; Identification of crystalline or semicrystalline structure; Analysis of degree of crystallinity; Detection of impurities; Trace level quantitation of most elements in liquid and solids; Measurement of sizes from 0.01 ?m to 3,500 ?m; Analyzing wet emulsion, suspension and bulk dry dispersion; Determination of diverse sample types: abrasive, fragile, cohesive or agglomerated.

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AMRI

AbbVie Contract Manufacturing

Aenova Group

Aizant Drug Research Solutions Pvt. Ltd.

Ascent Innovative Medicines

Ash Stevens, Inc.

Cambrex Corporation

ChemCon GmbH

DPT Laboratories, Ltd

Dishman Carbogen Amcis

GVK Biosciences

KriSan Biotech

Labiana Life Sciences S.A

Lubrizol Life Science Health

M-I-N-A-K E-M-2

Megsan Labs Private Limited

Neopharm Labs Inc

Nutrasource

PharmaVize NV

Quotient Sciences

RECRO GAINESVILLE

Ropack Inc

ScinoPharm Taiwan, Ltd

Servier CDMO

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Sushen Medicamentos Pvt. Ltd

Wavelength Pharmaceuticals

ZACH SYSTEM SA

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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

Virtual BoothGlobal leader for science based integrated drug development solutions

Physico-Chemical Characterization

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With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

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Finished Product Physical Characterization

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We have extensive experience in the testing of drug products including preclinical prototype evaluation, Excipient compatibility, Finished product testing including purity, dissolution, physical characterization ICH stability testing of drug products.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothCDMO (API & HPAPI)/ Generics/ Security of supply/ Regulatory submission expertise/ Track record performance/ FDA & GMP

Polymorph Characterization & Control

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Minakem's Solid Form Laboratory capturing a growing need from our clients to manage in-house polymorph characterization and control, crystalization conditions, filtration, drying and particle size reduction to add further value in process developemt and scale-up.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothWorld-Class Developer & Manufacturer of Differentiated APIs// in 50 countries// 198 DMFs Worldwide.

Characterization of Physical Properties

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We support your API development & manufacturing requirements. Our CDMO Services include Solid State / Polymorphism Research, Characterization of Physical Properties, Particle Design, cGMP scale Up, Process Validation, Stability Studies etc

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

Physiochemical Characterization

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We perform analytical testing services including raw material, in-process and finished product release testing, ICH stability testing, including photo stability, Physiochemical characterization, Method development and validation, residual solvents by GC.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothA leading process R&D and API Manufacturing service provider to the Global Pharmaceutical Industry.

Characterization of Polymorphs

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothEnergise your science for life

Physical Characterisation

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Dishman's offers various analytical characterization services such as Structure Elucidation, Physical Characterization, Polymorphism Investigation, DSC, XPRD, FTIR studies, Particle sizing, Impurity Profiling & Identification, Formulation studies, etc

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Virtual BoothCommitted to providing Highly Customized Solutions for all your Development Programs.

Solid State / Powder Characterization

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Solid state/powder characterization (microscopy, XRPD, SEM, DSC, IR, RAMAN, PSD, flowability properties)

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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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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Physiochemical Characteristics of Drug

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SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Initial Drug Substance Characterization

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To help you identify obstacles to the development of your compound, AMRI will collect, analyze and summarize all data necessary for your regulatory documentation needs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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API Characterization

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Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical Property Testing

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Our in-house Diteba laboratory provides a wide range of physical testing services, including:Loss on Drying, Moisture (Karl Fisher Titration and Coulometric),Color Determination, Container/Closure Integrity, Deliverable Volume etc.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical & Chemical Characterization

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Morphology Assessment

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Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Compound Identification & Characterization

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KriSan Biotech offers compound identification and characterization including API, impurities, degradants etc.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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API Solids Characterization

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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Particle Size Distribution

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Crystallinity Studies

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All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Particle Size Morphology

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Following an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physicochemical Properties

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Following an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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API Characterization

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Pharmavize operates an audited 1,600-m2 GMP facility serving clients from all over the world. We are thoroughly familiar with the European and American regulatory frameworks and guarantee compliance with all applicable guidelines and directives.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Analytical Characterization

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AbbVie Contract Manufacturing offers exceptional end-to-end biologics capabilities with some of the world’s most advanced production facilities.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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API Characterization

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extensive analytical development services and capabilities include

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical, Chemical, & Instrumental Analysis

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Aenova offers comprehensive analytical services in the field of physical, chemical, and instrumental analysis of drugs, active pharmaceutical ingredients, and excipients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Characterization of API & Raw Materials

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LABIANA GROUP offers a wide range of services in the analytical development area for pharmaceutical and veterinary industries.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical Characterization

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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: Analytical Testing Services

Sub Category: Physical Characterization

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Characterizations as Part of Quality & Identi...

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Chemcon's experience with pharmaceutical requirements and our broad chemical knowledge of small organic molecules, inorganic substances, and polymers allow our analytical team to collaborate with you on tailor-made solutions and analytical packages.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical Characterization

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Cambrex have the expertise to evaluate materials using a variety of techniques. Characterization of materials is performed using Polarizing Light Miscroscopy (PLM), DSC, Thermogravimetric Analysis (TGA), Laser Particle Size (LPS), & XRPD.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical Characterization

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DPT’s provides reliable and accurate analytical testing services for Light Microscopy, Mass spectrometry and LC / MS, Particle size, Physical Characterization, etc

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical Characterization

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We are the leading particulate and device based drug product physical characterization company. With growing frequency, regulators are requiring tight control over physical parameters such as particle or droplet size, viscoelastic properties

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Solid State Characterization

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Screening and quantification of polymorphic forms/impurity by pXRD; identification of melting point, eutectic point, glass transition temperature, heat of fusion and reaction, amorphous content, oxidative and thermal stability by DSC etc.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Physical & Chemical Properties

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GVK BIO performs stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

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Characterization of API, Product, Reference S...

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GVK BIO offers a broad range of analytical services for complex research needs. We perform characterization of API, product, reference standard and other pharmaceutical ingredients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Physical Characterization

Surface area and porosity are two important physical properties that determine the quality and utility of pharmaceutical materials. Differences in the surface area and porosity of particles within the material, which otherwise may have the same physical dimensions, can greatly influence its performance characteristics. Surface area and porosity play major roles in the purification, processing, blending, tableting and packaging of pharmaceutical products as well as the drug’s useful shelf life, its dissolution rate and bio-availability. In other healthcare applications such as regenerative medicine tissue scaffolds, controlling and optimizing the porosity of the scaffold material will help the tissue regrowth process. In analytical laboratories the use of materials with well-defined pore sizes and high surface areas are used in biochemical and pharmaceutical separation science. Understanding the physical properties of pharmaceutical solid materials is key to successful drug product and process development. These physical properties can have an impact on the material’s bulk properties, product performance, processability, stability and product appearance. The melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapour pressure, and density can all be affected. GLP, GCP or cGMP compliant physical characterization services assist with formulation or process development, regulatory submission data, QC testing, GMP lot release and manufacturing troubleshooting. Physical Characterization Testing Capabilities offered by Contraact Analytical service providers include: Calculation of BET surface area: single or multipoint; Determination of pore size and pore size distribution within 1.7 to 500 nm for macro, micro or mesoporous samples; Measurement of surface area as low as 0.001 m2 /g; Predicting reactivity, dissolution and compactness; Measurement of rate and ease of water permeation; Measurement of water vapor sorption - desorption isotherm; Measurement effect of sample environment on crystallinity or amorphous content; Determination changes in flow ability, compaction density and appearance; Determination phase and structural transition between -90 to 400°C; Directly measuring heat capacity; Analysis of complex and overlapping thermal changes - modulated DSC capable; Detection of weak thermal changes; Measurement of the change in sample mass as a function of temperature and/or time Monitoring moisture/Solvent loss [LOD on micro scale] Determination of rate of chemical degradation at various temperatures; Measurement of gas absorption-desorption; Identification of crystalline or semicrystalline structure; Analysis of degree of crystallinity; Detection of impurities; Trace level quantitation of most elements in liquid and solids; Measurement of sizes from 0.01 ?m to 3,500 ?m; Analyzing wet emulsion, suspension and bulk dry dispersion; Determination of diverse sample types: abrasive, fragile, cohesive or agglomerated.

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