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.

- Service Details

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

- Service Details

Temad utilizes Analytical Chemistry experts & various analytical equipment including HPLC, GC, FTIR, XRD, NMR, Mass Spectrometry for Method development, separation of active ingredients & impurities to conduct precise analyses according to BP, EP, USP.

- Service Details

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.

- Service Details

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

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

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.

- Service Details

Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

- Service Details

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

- Service Details

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.

- Service Details

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.