SERVICES TO HEALTH Analytical Reference Standards 2021 / 02 (v3) 1 Analytical SERVICES TO HEALTH Reference Standards Website Newsletter For information about LIPOMED’s To be updated on the release Reference Standards and about of new products, please request our new products continuously our newsletter by subscribing at: added to our product range, [email protected]. please visit www.lipomed.com. 2 Analytical SERVICES TO HEALTH Reference Standards NEW WEBSHOP USA /CH /DE /FR New Webshop LIPOMED will progressively expand its new webshop to simplify online ordering and the process of requesting quotes. www.lipomed-shop.com www.lipomed-usa.com 3 Analytical SERVICES TO HEALTH Reference Standards Table of Contents Company Profile ����������������������������������������������������������������������������������������� 5 Analytical Reference Standards . 7 Why choose LIPOMED Reference Standards . 12 Commitment to Quality ��������������������������������������������������������������������������� 13 Certificate of Analysis ������������������������������������������������������������������������������� 18 Tandem Mass Spectra Database ����������������������������������������������������������� 26 Contact Information . 28 Catalog User Guide ��������������������������������������������������������������������������������� 34 Aqueous Ethanol Standard Solutions ����������������������������������������������������� 35 Alphabetical Product List ������������������������������������������������������������������������� 36 Alphabetical Index. 254 Catalog Number Index . 263 Substance Class Index . 271 Standard Terms and Conditions of Sale ����������������������������������������������� 279 4 Analytical SERVICES TO HEALTH Reference Standards Company Profile LIPOMED is a private owned of Analytical Reference Standards research and development based and ISO 17034 (ANAB Certificate Health Care Company that No. AR-1761) accredited for serves the worldwide market for Reference Material production. Pharmaceuticals and Reference All products distributed by Standards. The headquarters is LIPOMED affiliates are manu- located in Arlesheim near Basel, factured by LIPOMED AG and Switzerland. distributed under protocols of LIPOMED AG. LIPOMED AG, Switzerland is GMP/GDP and ISO 9001 certified Additionally, the Pharma for production and distribution Marketing of LIPOMED is certified of Pharmaceuticals and according to the "Référentiel de ISO/IEC 17025 (ANAB Certificate certification de la visite médicale" No. AT-1760) accredited for testing by the French Authorities. 5 Analytical SERVICES TO HEALTH Reference Standards LIPOMED Inc. in Cambridge, Massachusetts, USA Lipomed Inc. is the distributor of our reference standards in North, Central and South America plus the Caribbean (except: Curaçao, Columbia, Argentina). LIPOMED GmbH in Weil am Rhein, Germany LIPOMED GmbH serves as a logistic and distribution center for Reference Standards and Pharmaceuticals in Germany. LIPOMED GmbH is also the Marketing Authorization Holder for the pharmaceutical products in Europe. It is ISO 9001 certified. 6 Analytical SERVICES TO HEALTH Reference Standards Analytical Reference Standards LPOMED is a leading producer and analytical techniques, LIPOMED supplier of Analytical Reference reference standards are available Materials manufactured according as calibrated ready-to-use (RTU) to the highest quality standards solutions as well as powders. currently given to reference This has been done to provide materials producers. Indeed, our customers additional flexibility LIPOMED holds ISO/IEC 17025 in choosing the most appropriate (ANAB certificate no. AT-1760) and form for their needs. ISO 17034 (ANAB certificate no. AR-1761) accreditations as well Our range of product offering as ISO 9001 certification to meet is continuously expanding in customers’ expectations for quality order to assist our customers and reliability. in providing the highest quality reference materials they need to LIPOMED reference standards perform their analysis. If you do currently include the following not find the product(s) you are classes of substances, their looking for please contact us. deuterated analogues and metabolites there of: For information about LIPOMED’s new Reference Standards, • Amphetamines & please visit www.lipomed.com. sympathomimetic amines • Antidepressants LIPOMED’s reference standards • Antipsychotics are available worldwide either • Aqueous ethanol standards through LIPOMED offices in • Barbiturates Europe and in the USA, and • Benzodiazepines through a selected network of • Cannabinoids appointed distributors for local • Cathinones customer services. Please see • Certified Reference Materials page 28 for LIPOMED offices and (CRMs) page 29 till page 33 for LIPOMED’s • CNS depressants appointed distributors or visit • Cocaines www.lipomed.com. • Custom mixtures • Designer drugs All reference standards distributed • Ethanol biomarkers by LIPOMED Inc. and by any other • Hallucinogens affiliate or partner company • Opioids under the LIPOMED label are • Steroids manufactured by the ISO certified • Vitamins company LIPOMED AG. Supplied as native and stable- isotope labeled for mass spectrometry and other 7 Analytical SERVICES TO HEALTH Reference Standards Transfer Labels LIPOMED progressively introduces providing safe and accurate calibrated ampoules with labels identification of vials used to store that can easily be transferred our calibrated reference standard from an ampoule to e. g. auto solutions after original ampoules sampler vials. This innovative are opened. feature supports customers in 8 Analytical SERVICES TO HEALTH Reference Standards Solutions and Powders available RTU Solutions are intended for LIPOMED’s Reference Standards quantitative ready-to-use purposes. are available as powders and Accurate strength is based on the as calibrated ready-to-use (RTU) free drug substance. solutions. 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 is based on the drug substance. RTU Solution Reference target volume of 1 ml can be Standards quantitatively transferred. LIPOMED’s 1mg/ml and 0.1 mg/ml RTU solutions offer many ampoules contain high precision advantages over powders such calibrated reference standards as accuracy in the provided to an accuracy of 1.000 ± solution strengths, enhanced 0.050 mg/ml and 0.100 ± consistency from lot to lot, and 0.005 mg/ml of free drug convenience of use, especially substance in sealed amber glass when used in routine testing. ampoules under argon for added stability. LIPOMED’s ampoules are over-filled to ensure that the 9 Analytical SERVICES TO HEALTH Reference Standards Manufacturing Aside from classical synthesis in batch reactors LIPOMED produces Reference Standards using Microflow Technology which guarantees unrivaled lot-to-lot identity and unmatched product purity. Ampoule Filling Lines Our calibrated solutions are produced in LIPOMED’s own ampoule filling lines to ensure batch-to-batch consistency and reproducibility. Analytical Quality Control calibrated solution, as well as for All our products in powder are each bulk powder. systematically analyzed in-house to ensure the identity and the LIPOMED is also providing its purity of our reference standards. reference standards solutions IR, UV, melting point, MS, Proton as Certified Reference Materials NMR are used to confirm the (CRMs) according to ISO/IEC identity of the products and HPLC, 17025 and ISO 17034 guidelines. GC, LC/MS or HPTLC CAMAG are Ampoules are analyzed to ensure used to monitor the chemical a level of confidence of 95 % and and isotopic purity of our stability data are performed on reference standards. each product (non-deuterated and deuterated). A lot specific certificate of analysis is available for each 10 Analytical SERVICES TO HEALTH Reference Standards Shelf life Retest and expiry dates should Stability monitoring is performed be read as per end of the stated on all Reference Standards at month. appropriate intervals. Storage For most of LIPOMED’s Reference Airtight storage at a temperature Standards, retest dates are of 2 – 8 °C in a dark location is provided on the Certificates recommended, unless otherwise of Analysis (COA) together indicated on the label and in the with the corresponding batch COA. numbers. Retests are performed by LIPOMED 6 months prior to the Use stated retest dates. This allows for LIPOMED Reference Standards a validity extension of the retested are not qualified for administration batch subject to successful retest, in humans or animals. In addition, proper storage and unopened our Reference Standards are ampoules/vials. not qualified against official Pharmacopoeia Reference Updated COA are available Standards. Therefore GLP, GCP or on the website or by e-mail: GMP applications are under the [email protected] (North, full responsibility of the end user. Central and South America plus the Caribbean, except: Curaçao, Safety Columbia, Argentina) and All products mentioned in this [email protected] (all other catalog have to be considered countries). potentially toxic substances and must be handled by suitably trained staff. 11 Analytical SERVICES TO HEALTH Reference Standards Why choose LIPOMED Reference Standards • Privately owned with 25 Years • Special products available of Consistency, Quality, and such as alcohol biomarkers, Precision custom mixtures, designer drugs, opiates glucuronides, • Pharmaceutical