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Pharmaceutical and biopharmaceutical development and manufacturing is becoming more complex and expensive. The need for more elaborate material characterization and tighter quality control requirements combined with tighter time constraints places considerable demands on analysis. Rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) have a wide range of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. The main advantage these techniques provide is a reduction in analysis time providing higher throughput which can lower costs and shorten the time to market. X-Ray Powder Diffraction (XRPD) continues to be an indispensable analytical technique supporting a wide variety of pharmaceutical development activities. X-ray powder diffraction (XRPD) is a core technique for the identification and characterization of solid pharmaceutical materials in terms of the structural order or disorder of solid APIs or other substances. Solid forms of a given molecule exhibiting long-range crystalline order (e.g., polymorphs, solvates, co-crystals, and salts) can be identified and characterized using XRPD by their unique combination of order parameters and well defined sharp diffraction peaks. Different phases, or polymorphs, within a particular material can be distinguished from one another by their unique X-ray powder diffraction (XRPD) patterns. Forming a key technique in our suite of physical characterization capabilities, Contract Analytical Service providers apply XRD to crystal morphology requirements supporting drug development, regulatory submission data and GMP lot release. They also provide GLP compliant XRD services. Advances in PXRD instrumentation and software have improved the efficacy of pharmaceutical drugs, efficiency of solid state characterization and rapid analysis of composites and materials. Variable temperature and humidity techniques are especially powerful in understanding structural changes of pharmaceutical drugs to enhance the stability and screen the drug substances under variable conditions. Ongoing developments involving structure determination directly from PXRD are encouraging to determine the crystal structures of new synthesized compounds and in pharmaceuticals. XRD in association with DSC, TGA, DTA, FTIR techniques can solve numerous problems encountered in industries for pharmaceutical formulation and pharmaceutic developments. The excellence of this technique is catering to academic research and commercial use in industries. Powder X-Ray Diffraction technique is a key analytical technique to serve the growth and development of Science and Technology.

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AMRI

Aizant Drug Research Solutions Pvt. Ltd.

Arbro Pharmaceuticals Pvt. Ltd

Crystec Pharma

Dannalab B.V

Dishman Carbogen Amcis

Globela Pharma Pvt. Ltd.

M2M Pharmaceuticals Ltd

Megsan Labs Private Limited

Minakem

Neuland Laboratories Inc

PCI Synthesis

PROCOS S.p.A.

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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

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

X-Ray Power Diffraction (XRPD)

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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: XRPD

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Polymorphism Investigation

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Dishman's analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD (XRD) to Study Polymorphism

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XRPD (XRD) is an important analytical technique for the characterization of small-molecule drugs, providing direct information about the state of an active pharmaceutical ingredient (API). XRPD (XRD) patterns form an essential aspect of patent applications for new polymorphic forms.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD (XRD) for API Development

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Since XRPD patterns are directly related to the crystalline structure of a material, this is an ideal technique for the screening, identification and characterization of polymorphic forms and new chemical entities in API discovery and development.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD (XRD) Testing of the Quality of Raw Mate...

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XRPD serves as an important tool for controlling purity, crystallinity and polymorphism for API and excipients.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD (XRD) for Preformulation & Formulation

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The non-destructive nature of XRPD makes it a suitable technique for systematic preformulation studies and for testing drug-excipient compatibility. Excipient interactions are critical to the consistent release and bioavailability of the API.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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X-Ray Powder & Single Crystal Diffractometers

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The company operates across three key sites (as listed below), and each incorporates characterisation and analytical suites which include - X-ray powder and single crystal diffractometers.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD (XRD) for Manufacturing & QC

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XRPD is used to monitor the quality of the finished drug product by determining the micro-structural parameters of the API and by detecting and quantifying the presence of pharmaceutical polymorphic contaminations.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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Solid State Studies (XRD)

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Procos S.p.A. is specialized in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and Generic API manufacturing.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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X-ray diffraction (XRD)

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Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRPD Study of Transdermal Patch

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XRPD characterization of a transdermal device may cover the properties of pharmaceutical formulation: crystallinity and polymorphic impurities in bulk or as distribution, or the material properties of patch components, such as- polymer structures, films and adhesives.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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X-Ray Crystallography

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Through a cooperative agreement with local universities such as Clark University in Worcester, MA, PCI also provides advanced non-GMP testing techniques including: X-ray Crystallography.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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XRD (PANalytical)

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Neuland has a separate, specially equipped R&D Centre located at Bonthapally. Custom Synthesis is another area where Neuland has been concentrating and is taking up several projects. We work in close association with clients, under strict confidentiality, to bring products early to markets.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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pXRD (X-Ray Diffraction)

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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: Analytical Testing Services

Sub Category: XRPD

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XRD & PSD

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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: XRPD

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XRPD (Powder, T and RH stage, High Throughput...

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M2M Pharmaceuticals Ltd, a Contract Research Organization (CRO) supports early stage product development for pharmaceutical, food and biotech companies with various services in Method Development and Validation, Physico-Chemical Analysis, Formulation and Quality/Regulatory support.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

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Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: XRPD

Pharmaceutical and biopharmaceutical development and manufacturing is becoming more complex and expensive. The need for more elaborate material characterization and tighter quality control requirements combined with tighter time constraints places considerable demands on analysis. Rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) have a wide range of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. The main advantage these techniques provide is a reduction in analysis time providing higher throughput which can lower costs and shorten the time to market. X-Ray Powder Diffraction (XRPD) continues to be an indispensable analytical technique supporting a wide variety of pharmaceutical development activities. X-ray powder diffraction (XRPD) is a core technique for the identification and characterization of solid pharmaceutical materials in terms of the structural order or disorder of solid APIs or other substances. Solid forms of a given molecule exhibiting long-range crystalline order (e.g., polymorphs, solvates, co-crystals, and salts) can be identified and characterized using XRPD by their unique combination of order parameters and well defined sharp diffraction peaks. Different phases, or polymorphs, within a particular material can be distinguished from one another by their unique X-ray powder diffraction (XRPD) patterns. Forming a key technique in our suite of physical characterization capabilities, Contract Analytical Service providers apply XRD to crystal morphology requirements supporting drug development, regulatory submission data and GMP lot release. They also provide GLP compliant XRD services. Advances in PXRD instrumentation and software have improved the efficacy of pharmaceutical drugs, efficiency of solid state characterization and rapid analysis of composites and materials. Variable temperature and humidity techniques are especially powerful in understanding structural changes of pharmaceutical drugs to enhance the stability and screen the drug substances under variable conditions. Ongoing developments involving structure determination directly from PXRD are encouraging to determine the crystal structures of new synthesized compounds and in pharmaceuticals. XRD in association with DSC, TGA, DTA, FTIR techniques can solve numerous problems encountered in industries for pharmaceutical formulation and pharmaceutic developments. The excellence of this technique is catering to academic research and commercial use in industries. Powder X-Ray Diffraction technique is a key analytical technique to serve the growth and development of Science and Technology.

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