Analytical SERVICES TO HEALTH Reference Standards Reference Standards 2014/04 1 Analytical SERVICES TO HEALTH Reference Standards 2 Analytical SERVICES TO HEALTH Reference Standards Table of Contents Company Profi le page 4 Reference Standards page 6 Why choose Lipomed Reference Standards? page 9 Commitment to Quality page 10 Certifi cate of Analysis page 14 Catalog User Guide page 21 Contact Information page 23 Aqueous Ethanol Standard Solutions page 29 Alphabetical Product List page 31 Alphabetical Index page 189 Catalog Number Index page 197 Substance Class Index page 203 Standard Terms and Conditions of Sale page 207 3 Analytical SERVICES TO HEALTH Reference Standards Company Profi le Lipomed is a private research and development based Health Care Com- pany that serves the worldwide market for Pharmaceuticals and Reference Standards. The headquarters are located in Arlesheim near Basel, Switzerland. Lipomed AG, Switzerland is GMP /GDP and ISO 9001:2008 certifi ed for pro- duction and distribution of Pharmaceuticals and ISO/ IEC 17025:2005 (ACLASS Certifi cate No. AT-1760) accredited for testing of Analytical Refer- ence Standards and ISO Guide 34:2009 (ACLASS Certifi cate No. AR-1761) accredited for Reference Material production. All products distributed by Lipomed Affi liates are manufactured by Lipomed AG and distributed under protocols of Lipomed AG. 4 Analytical SERVICES TO HEALTH Reference Standards Lipomed Inc. in Cambridge, Massachusetts, USA Lipomed Inc. is the sole distributor for the US and Canadian markets for Reference Standards. Lipomed GmbH in Weil am Rhein, Germany Lipomed GmbH serves as a Logistics and Distribution Center for Europe for Reference Standards and Pharmaceuticals. Lipomed GmbH is also the Marketing Authorization Holder for the pharmaceutical products in Europe. It is ISO 9001:2008 certifi ed. Lipomed GmbH in Vienna, Austria The Austrian subsidiary of Lipomed is responsible for the marketing of Lipomed’s products in Austria and Eastern Europe. 5 Analytical SERVICES TO HEALTH Reference Standards Reference Standards Lipomed is a leading producer and supplier of analytical reference materials manufactured according to the highest quality standards currently given to reference materials producer. Indeed, Lipomed holds ISO / IEC 17025:2005 (ACLASS Certifi cate No. AT-1760) and ISO Guide 34:2009 (ACLASS Certifi cate No. AR-1761) accreditations as well as ISO 9001:2008 certifi cation to meet customers’ expectations for quality and reliability, Supplied as native and stable-isotope labeled for mass spectrometry and other analytical techniques, Lipomed reference standards are available as calibrated ready-to-use (RTU) solutions & powders as well as powders in larger pack sizes. This has been done to provide our customers additional fl exibility in choosing the most appropriate form for their needs. Lipomed reference standards currently include the following classes of sub- stances, their deuterated analogues and metabolites such as Glucuronides and Sulfates: • Alcohol & Ethanol Biomarkers • Cannabinoids • Amphetamines & • Cathinones Sympathomimetic amines • Cocaines • Antidepressants • Hallucinogens • Antipsychotics • Opioids • Barbiturates • Other CNS Depressants • Benzodiazepines • Steroids Our range of product offering is continuously expanding in order to assist our customers in providing the highest quality reference materials they need to perform their analysis. If you do not fi nd the product(s) you are looking for please contact us. Lipomed’s reference standards are available worldwide either through Li- pomed offi ces in Europe and in the USA, and through a selected network of appointed distributors for local customer services. Please see page 23 for Lipomed offi ces and page 24 for Lipomed’s appointed distributors. For information about Lipomed’s new Reference Standards, please visit www.lipomed.com. To be updated on the release of new products, please request our newslet- ter by subscribing at: [email protected] All reference standards distributed by Lipomed Inc. and by any other Affi liate or Partner Company under the Lipomed label are manufactured by the ISO certifi ed company Lipomed AG. 6 Analytical SERVICES TO HEALTH Reference Standards Solutions and Powders Available Lipomed’s Reference Standards are available as calibrated ready-to-use (RTU) solutions and as calibrated ready-to-use (RTU) powders fi lled in ampoules or in 20 ml vials respectively. • RTU Solutions • RTU Powders RTU Solutions and RTU Powders are intended for quantitative ready-to-use pur- poses. Accurate weight and / or strength are based on the free drug substance. Lipomed’s Reference Standards are also available as powders in standard pack sizes of 10 mg, 50 mg and 100 mg. Larger quantities might be available upon request. The weight and / or strength are based on the drug substance. RTU Solution Reference Standards Lipomed’s 1mg/ml and 0.1 mg/ml ampoules contain high precision calibrat- ed Reference Standards to an accuracy of 1.000 ± 0.050 mg/ml and 0.100 ± 0.005 mg/ml of free drug substance in sealed amber glass ampoules under argon for added stability. Lipomed’s ampoules are over-fi lled to ensure that the target volume of 1ml can be quantitatively transferred. RTU Powder Reference Standards Lipomed’s 1mg vials contain high precision calibrated freeze-dried Reference Standards to an accuracy of 1.000 ± 0.050 mg of free drug substance in 20ml amber glass septum-capped vials. Instructions for the Safe use of RTU Powder Reference Standards Calibrated standard solutions are prepared in an easy and safe way as follows: 1. Clip off the aluminum center of the cap. 2. Add the solvent of choice through the septum using a gas tight precision syringe. Gently shake and invert the vial several times to ensure complete dissolution of the powder. 3. Withdraw the desired volume of calibrated solution through the septum using a syringe. 7 Analytical SERVICES TO HEALTH Reference Standards Shelf life Stability monitoring is performed on all Reference Standards at appropriate intervals. For most of Lipomed’s Reference Standards, Retest Dates are provided on the Certifi cates of Analysis together with the corresponding batch numbers. Retests are performed by Lipomed prior to the stated retest dates. This allows for a validity extension of the retested batch subject to successful retest, proper storage and unopened ampoules/vials. Updated certifi cates of analysis are available on the website or by e-mail: [email protected] (USA, Canada, Bermuda) and [email protected] (all other countries). Retest and expiry dates should be read as per end of the stated month. Storage Airtight storage at a temperature of 2 – 8 °C in a dark location is recommended, unless otherwise indicated on the label. Use Lipomed's Reference Standards are not qualifi ed for use in controlled GLP and GCP experiments and must not be used in human or animal preclinical or clinical trials. Lipomed reference standards are also not qualifi ed for con- trol of GMP regulated manufacturing. Safety All products mentioned in this catalog have to be considered potentially toxic substances and must be handled by suitably trained staff. 8 Analytical SERVICES TO HEALTH Reference Standards Why choose Lipomed Reference Standards? • Calibrated Reference Standards available in both powder form and as solutions from a single source. • Retest dates instead of expiry dates provided for most of Lipomed Reference Standards’ lot. • Large choice of standard strengths and quantities available: 0.1 mg/ml, 1 mg, 1 mg/ml, 10 mg, 50 mg, 100 mg. • Gram quantities and higher available on request. • Special products available such as alcohol biomarkers, designer drugs, opiates glucuronides, “street heroin”, THCA-A, etc. • Fast delivery from local stocks held in Switzerland, Germany, France and the USA. • High quality Reference Standards supplied with lot-specifi c certifi cates of analysis. • Lot-to-lot consistency regulated by rigorous product specifi cations and quality control SOPs. • Check Lipomed’s quality before ordering: product specifi cations available at www.lipomed.com • Competitive pricing • Lipomed AG is ISO 9001:2008 certifi ed and ISO/IEC 17025:2005 (ACLASS Certifi cate No. AT-1760), ISO Guide 34:2009 (ACLASS Certifi cate No. AR-1761) accredited. 9 Analytical SERVICES TO HEALTH Reference Standards Commitment to Quality Lipomed AG, Switzerland is GMP/GDP and ISO 9001:2008 certifi ed for pro- duction and distribution of Pharmaceuticals and ISO/IEC 17025:2005 (ACLASS Certifi cate No. AT-1760) accredited for testing of Analytical Refer- ence Standards and ISO Guide 34:2009 (ACLASS Certifi cate No. AR-1761) accredited for Reference Material production. All products distributed by Lipomed Affi liates are manufactured by Lipomed AG and distributed under protocols of Lipomed AG. 10 Analytical SERVICES TO HEALTH Reference Standards 11 Analytical SERVICES TO HEALTH Reference Standards CERTIFICATE IQNet and SQS hereby certify that the organisation Lipomed AG 4144 Arlesheim Switzerland Certified area Whole company Field of activity Manufacturing, analysis, packaging and distribution of analytical reference materials and pharmaceuticals has implemented and maintains a Management System which fulfills the requirements of the following standard(s) ISO 9001:2008 Scope No(s): 13 Issued on: 2013-06-16 Validity date: 2016-06-15 Registration Number: CH-37199 Michael Drechsel Roland Glauser President of IQNet CEO SQS IQNet Partners*: AENOR Spain AFNOR Certification France AIB-Vinçotte International Belgium ANCE-SIGE Mexico APCER