Reference Substances – Customized for Individual Analytical Processes Brochure

Reference Substances – Customized forIndividual Analytical ProcessesSolvias – your reliable partnerReference Substances – Customized forAll Individual Analytical ProcessesAs a one-stop service provider with many years of experience in research and industry, we are yourpartner for customized reference substances. We can provide comprehensive, individually tailoredsupport for all your analytical processes, whether for identity testing or for the quantitative analysisof active substances, intermediates, by-products and degradation products.Solvias – your reliable partner for custom-tailored solutionsReliable reference substances make a crucial contribution to the accuracy of the analytical results for chemical and pharmaceu-tical products. As your competent and reliable partner, we can help by providing you with individual reference substanceswhich are suitable for the intended use. This provides you with security in official audits and for the registration of your products.You can benefit from our comprehensive, modular range of services from a single source – structural elucidation, isolation,purification, characterization, synthesis design, contract synthesis, certification/re-certification, documentation, packaging,storage and world-wide supply. Use our strengths to your advantage.? Unique and varied range of methods and broad spectrum of services for individually matched, customer-specific solutions? Decades of experience in the synthesis and analysis of highly active, cytostatic, photosensitive and complex compounds? Considerable flexibility and capacity in synthesis development and contract synthesis of multi-stage asymmetrical com-pounds? Modern infrastructure: kilo laboratory; safety boxes for fluorination, carbonylation, high-pressure and hydration reactions;special laboratories for photosensitive and for cytotoxic compounds? Preparative isolation and purification techniques from µg to kg scale (chromatography, crystallization)? Unique range of physico-chemical, analytical and spectroscopic methods for characterization? Greater efficiency as a result of synthesis, purification and analysis from a single source? Problem-focused consulting on certification issues and on establishing of individual test protocols? Comprehensive project management and co-ordination due to global network of expertise and experience2 31Sample concentration in a nitrogen streamLiquid chromatographyGC-headspace autosampler123Officially recognized expertiseSolvias – your supplier with officially recognized expertise As a world-wide supplier to the chemical and pharmaceutical industry, we not only possess the necessary experience but alsoofficially recognized expertise in the manufacture, certification, characterization and documentation of customized referencesubstances.? cGMP recognition by the FDA, CFN: 9617363? cGMP-approved by Swissmedic for chemical, physical, biochemical and microbiological analysis of medicinal products? GLP-certified test facility? Certified according to ISO 9001ServicesLyophilizator in the amber light laboratory (for photosensitive compounds)Application device for preparative layer chromatographyCrude material obtained from synthesis1232 31Solvias – your partner for individual customer-specific solutionsSynthesis? Manufacture and supply of primary and secondary reference substances ? Establishment of customer-specific working standards? Synthesis design – innovative production of individual, complex reference substances in various quantity units? Contract synthesis – manufacture of customer-specific reference substances according to a specified synthesis schedule(mg to kg)? Preparation of seed crystals with defined polymorphic structure? Manufacture, analysis and packaging of photosensitive, deuterated, cytotoxic and polymorph forms of reference substancesEnrichment, isolation and purification? Enrichment of impurities and by-products through crystallization, distillation, extraction, chromatography? Preparative chromatography (isolation and purification) from the analytical to preparative scale on various stationary phases (with TLC, LC, HPLC) ? Isolation of asymmetrical compounds (enantiomers)Characterization, certification and re-certification? Analytical and spectroscopic characterization of active substances, including protein therapeutics, by-products and degra-dation products? Structural elucidation and confirmation of unknown compounds using spectroscopic and coupled techniques (NMR, Ramanand infrared spectroscopy; mass spectrometry; LC-MS, GC-MS, GC-IR, TG-FTIR)? Analytical and physico-chemical investigations for certifications and re-certifications? Method development and validationPackaging, storage and shipping? Packaging under inert gas atmosphere and with exclusion of light? Functional packaging – containers with tamper-proof screw caps ? Packaging of small quantities (vials, ampoules)? Stability testing and monitoring of your stored compounds? World-wide supply and on-demand delivery of your specific reference substances? Temperature-monitored, restricted-access warehouseSolvias – Our Wide Spectrum of ServicesSolvias reference substancesSolvias – Your Partner for IndividualCustom-Tailored Solutions for SynthesisProcesses? Customized reference substancesfor individual identity tests andquantitative assays in all analyticalprocesses? Certification services matched tospecific needs and desired applica-tions? Unusually wide range of methodsfor analytical and physico-chemicalcertification/re-certification, inclu-ding professional documentationfor reliable acceptance by theauthorities? Cost-effective co-ordination –synthesis, purification and analysisfrom a single source? Unique know-how for the synthesisdevelopment of nucleosides,heterocycles (natural substances)and asymmetrical, deuterated andcytotoxic molecules? Innovative problem-solving strate-gies in the synthesis design ofchemoselective, regioselective,stereoselective or enantioselectivemolecules? Efficient manufacture of com-pounds due to access to ourcatalysis know-how and over 200ligands with approved applica-tions? Savings in time, labor and costs –no need to develop special analyt-ical techniques in-house or set upa separate synthesis laboratory; noprotracted, cost-intensive learningphase? Saving of resources due to accessto special laboratories and techno-logies for fluorinations, carbonyla-tions, decarbonylations, hydro-formylations, Suzuki aryl-arylcouplings, Buchwald-Hartwigaminations, Heck-type arylations,Cl-CN exchange reactions? Reliability in the production ofyour active substances due to theuse of characterized seed crystalsof desired polymorphic form? Substances supplied in variousquantity units and containers (bulkfilling, vials, ampoules) for every-day laboratory needs – no contam-ination, less administration, noadditional testing necessary? Simple on-demand delivery ofyour reference substances (fromthe warehouse), including an up-to-date certificate of analysis? World-wide, rapid, reliable deliveryadapted to the needs of the cus-tomerSolvias reference substances – highly efficient and customer-oriented20-liter distillation apparatusHigh-pressure parallel reactor1221Solvias AGP.O. Box4002 BaselSwitzerlandTel. +41 61 686 61 61Fax +41 61 686 65 65www.solvias.cominfo@solvias.com