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

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

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

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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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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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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.

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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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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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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.