DOCSLIB.ORG

Pharmaceutical Impurities and Primary Reference Standards Catalogue

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmaceutical Impurities and Primary Reference Standards Catalogue ALL PRODUCTS LINK TO OUR WEBSHOP INCLUDES SINCENEW M RELE A A A LL RCH 2015SES Pharmaceutical impurities and primary reference standards Catalogue supplement 2016 detailed certificates of analysis • acknowledged by r egu lat or y au th o r it ie s w o r l d w i d e • p h a r m a c e u t i c a l i m p u r i t i e s • c u s t o m s y n t h e s i s e d i m p u ities ities r • pharmaceutical primary standards primary pharmaceutical LGC Quality - ISO 9001 • ISO/IEC 17025 • ISO Guide 34 • GMP/GLP • ISO 13485 • ISO/IEC 17043 Dear customer, Welcome to our 2016 supplement, updating our Also, we would like to take the opportunity to inform pharmaceutical impurities and primary reference you about some exciting news about our production standards catalogue which we released in early facilities in Luckenwalde, Germany: 2015. • We will open a state-of-the-art warehouse in early With this update, we provide more than 1,100 autumn which will serve as the main hub for our new reference standards for impurity and active global logistics operations pharmaceutical ingredient (API) testing to the global pharmaceutical quality control community. • During our quality audit in January 2016, we have renewed our GMP confirmation Our impurities range under the MM brand features close to 4,000 reference standards for impurity and • We have further improved our synthesis capacities APIs, suitable for almost any application in analytical for you to obtain more relevant substances in research and development, method validation and shorter time and to characterise them as important routine quality control. reference standards for pharmaceutical QC Our range of primary reference standards covers For further information, also on how to best use our now more than 100 substances. With each product reference standards, we would like to point you to you will get an extensive certificate of analysis the introduction of our 2015 catalogue version. fulfilling ICH’s, FDA’s and other regulatory body requirements for primary standards in pharmaceutical You don’t find what you are looking for? Please quality control. contact the local LGC office close to you, all contacts are on the back of this catalogue. We produce our primary reference standards under ISO Guide 34, the highest possible quality regimen For technical questions please email us at worldwide, to which we are accredited. [email protected]. Best regards Your LGC team Be surprised… Finding reference materials online is easier than ever before Discover more than 10,000 pharmaceutical reference materials. All relevant industry suppliers. Available for easy online ordering. Try our new powerful search tools and filter by: • Pharmaceutical product type • Method • Producer • API family • Application area @LGCStdsPharma lgc-standards-pharma www.lgcstandards.com • Science for a safer world LGC Quality ‒ ISO 9001 • ISO/IEC 17025 • ISO Guide 34 • GMP/GLP • ISO 13485 • ISO/IEC 17043 © LGC Limited, 2016. All rights reserved. LGC Standards is part of the LGC Group. 4677/GJ/0316 Impurities @LGCStdsPharma www.lgcstandards.com Pharmaceutical impurities Code Product CAS No. CS Price Unit 2-Thiouracil O N e MM3270.00 2-Thiouracil 141-90-2 A 250mg H N w S N H 4-Aminobenzoic Acid N O e MM1255.08 Isopropyl 4-Aminobenzoate 18144-43-9 A 100mg O w H2 N Abacavir Sulfate N H2 N N Imp. C (EP): [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl) N N e MM3249.01 124752-25-6 A 100mg H 2 N N cyclopent-2-enyl]methanol w OH Acamprosate Calcium N Imp. A (EP): 3-Aminopropane-1-sulfonic Acid O O e MM3407.01 3687-18-1 A 100mg H 2N S (Homotaurine) OH w Acecarbromal N O O O Br e MM1724.00 Acecarbromal 77-66-7 A 50mg N N H H w Aceclofenac O O N O O e MM0181.11 Aceclofenac Isopropyl Ester n/a A 100mg N H Cl Cl w O OH O O O N H N Cl Cl Aceclofenac 1,3-Butylene Glycol Esters (Mixture of e MM0181.12 n/a A 100mg O Isomers) O w O OH O N H Cl Cl Visit us at www.lgcstandards.com 1 Pharmaceutical impurities Code Product CAS No. CS Price Unit O O O O OH N H N Cl Cl Aceclofenac 1,2-Propylene Glycol Esters (Mixture of e MM0181.14 n/a A 100mg O O OH Isomers) O w O N H Cl Cl Acefylline O N O OH N e MM1727.00 Acefylline 652-37-9 A 250mg N w O N N Acemetacin N O O O O N e MM1728.01 Acemetacin Methyl Ester 681838-84-6 A 100mg O O w Cl N O O O O N e MM1728.02 Acemetacin Ethyl Ester 76812-43-6 A 100mg O O w Cl N O O O O N e MM1728.03 Acemetacin Isopropyl Ester n/a A 100mg O O w Cl O OH O O O N N O Acemetacin 1,3-Butylene Glycol Esters (Mixture of O Cl e MM1728.05 n/a A 100mg O O O Isomers) O OH N w O O Cl N O O O O N e MM1728.06 Acemetacin 2,3-Butylene Glycol Ester n/a A 100mg O OH O w Cl O O O O N N O OH Acemetacin 1,2-Propylene Glycol Esters (Mixture of O MM1728.07 n/a A 100mg Cl e O O O OH Isomers) O N w O O Cl O O O O OH N N O OH O Cl e MM1728.08 Acemetacin 1,2,3-Propanetriol Esters (Mixture of Isomers) n/a A 100mg OH O O O OH O N w O O Cl Acenocoumarol O N O O N + O e MM1205.00 Acenocoumarol 152-72-7 A 250mg OH w O Visit us at www.lgcstandards.com 2 Pharmaceutical impurities Code Product CAS No. CS Price Unit Acepromazine N O N N OH S e MM0927.00 Acepromazine Maleate 3598-37-6 A 250mg OH O w O Acetildenafil N O N O H N N N e MM1269.00 Acetildenafil 831217-01-7 A 100mg N N w O Acetylcysteine O N e MM0024.10 N-Acetyl-L-cysteine Isopropyl Ester 73255-51-3 A 100mg H S O H N w O Acetylsalicylic Acid N O e MM0133.11 4-Acetoxybenzoic Acid 2345-34-8 B 100mg O OH w O O N O e MM0133.12 Methyl Acetylsalicylate 580-02-9 A 100mg w O O O N O e MM0133.14 Isopropyl Acetylsalicylate 2224-88-6 A 50mg O w O N O OH O O e MM0133.19 Hexanedioic Acid Mono-(2-carboxyphenyl) Ester 863985-44-8 A 50mg OH w O N H O O O O MM0133.20 O O e Hexanedioic Acid Bis-(2-carboxyphenyl) Ester 69638-07-9 A 100mg O OH w Acitretin N O e MM3427.00 Acitretin 55079-83-9 A 250mg OH O w Visit us at www.lgcstandards.com 3 Pharmaceutical impurities Code Product CAS No. CS Price Unit Adapalene Br N e MM0681.05 Methyl 6-Bromo-2-naphthoate 33626-98-1 A 100mg O w O N O Methyl 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoate e MM0681.06 106685-41-0 A 100mg (Adapalene Methyl Ester) O w O Adefovir Dipivoxil N H2 O N N N O O N P O N O e MM3505.00 Adefovir Dipivoxil 142340-99-6 A 250mg O w O O Agomelatine H N N e MM3583.00 Agomelatine 138112-76-2 A 250mg O w O N N e MM3583.01 7-Methoxy-1-naphthaleneacetonitrile 138113-08-3 C 100mg w O Alanine N N H Imp. B (EP): (2S)-2-Aminopentanedioic Acid (Glutamic 2 e MM1333.00 56-86-0 A 250mg H O OH Acid) w O O Alclofenac N Cl O e MM1783.01 Alclofenac Methyl Ester 23918-07-2 A 100mg O O w N Cl O O e MM1783.02 Alclofenac Ethyl Ester 20788-45-8 A 100mg O w N Cl O O e MM1783.03 Alclofenac Isopropyl Ester 69801-29-2 A 100mg O w Visit us at www.lgcstandards.com 4 Pharmaceutical impurities Code Product CAS No. CS Price Unit Alfacalcidol N e MM3002.00 Alfacalcidol 41294-56-8 A 50mg H w H O OH Allantoin N O O H N 2 N H e MM1627.00 Allantoin 97-59-6 A 250mg N H N O w H Allopurinol O N Ethyl (E/Z)-3-(2-Carbethoxy-2-cyanoethenyl)amino-1H- O e MM0034.10 321571-07-7 A 100mg N N pyrazole-4-carboxylate N N w H H O O Alprostadil O N O OH e MM1553.00 Alprostadil 745-65-3 A 50mg HO w H O Amfenac Sodium Monohydrate N O N H2 e MM3533.01 Amfenac Methyl Ester 61941-58-0 A 100mg O O w N O N H2 e MM3533.02 Amfenac Ethyl Ester 61941-57-9 A 100mg O O w N O N H2 e MM3533.03 Amfenac Isopropyl Ester n/a A 100mg O O w O N H O N e MM3533.08 7-Benzoylindolin-2-one (Amfenac Lactam) 51135-38-7 A 100mg w Amfetamine Sulfate N N H 2 e MM0741.06 Amfetamine Hydrochloride 2706-50-5 CS A 100mg HCl w Visit us at www.lgcstandards.com 5 Pharmaceutical impurities Code Product CAS No.
Load more

Recommended publications
  • Novel Neuroprotective Compunds for Use in Parkinson's Disease
    Novel neuroprotective compounds for use in Parkinson’s disease A thesis submitted to Kent State University in partial Fulfillment of the requirements for the Degree of Master of Science By Ahmed Shubbar December, 2013 Thesis written by Ahmed Shubbar B.S., University of Kufa, 2009 M.S., Kent State University, 2013 Approved by ______________________Werner Geldenhuys ____, Chair, Master’s Thesis Committee __________________________,Altaf Darvesh Member, Master’s Thesis Committee __________________________,Richard Carroll Member, Master’s Thesis Committee ___Eric_______________________ Mintz , Director, School of Biomedical Sciences ___Janis_______________________ Crowther , Dean, College of Arts and Sciences ii Table of Contents List of figures…………………………………………………………………………………..v List of tables……………………………………………………………………………………vi Acknowledgments.…………………………………………………………………………….vii Chapter 1: Introduction ..................................................................................... 1 1.1 Parkinson’s disease .............................................................................................. 1 1.2 Monoamine Oxidases ........................................................................................... 3 1.3 Monoamine Oxidase-B structure ........................................................................... 8 1.4 Structural differences between MAO-B and MAO-A .............................................13 1.5 Mechanism of oxidative deamination catalyzed by Monoamine Oxidases ............15 1 .6 Neuroprotective effects
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2013/0253056A1 Nemas Et Al
    US 20130253 056A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0253056A1 Nemas et al. (43) Pub. Date: Sep. 26, 2013 (54) CONTINUOUS ADMINISTRATION OF (60) Provisional application No. 61/179,511, filed on May LEVODOPA AND/OR DOPA 19, 2009. DECARBOXYLASE INHIBITORS AND COMPOSITIONS FOR SAME Publication Classification (71) Applicant: NEURODERM, LTD., Ness-Ziona (IL) (51) Int. Cl. A63L/216 (2006.01) (72) Inventors: Mara Nemas, Gedera (IL); Oron (52) U.S. Cl. Yacoby-Zeevi, Moshav Bitsaron (IL) CPC .................................... A6 IK3I/216 (2013.01) USPC .......................................................... 514/538 (73) Assignee: Neuroderm, Ltd., Ness-Ziona (IL) (57) ABSTRACT (21) Appl. No.: 13/796,232 Disclosed herein are for example, liquid aqueous composi (22) Filed: Mar 12, 2013 tions that include for example an ester or salt of levodopa, or an ester or salt of carbidopa, and methods for treating neuro Related U.S. Application Data logical or movement diseases or disorders such as restless leg (63) Continuation-in-part of application No. 12/961,534, syndrome, Parkinson's disease, secondary parkinsonism, filed on Dec. 7, 2010, which is a continuation of appli Huntington's disease, Parkinson's like syndrome, PSP. MSA, cation No. 12/836,130, filed on Jul. 14, 2010, now Pat. ALS, Shy-Drager syndrome, dystonia, and conditions result No. 7,863.336, which is a continuation of application ing from brain injury including carbon monoxide or manga No. 12/781,357, filed on May 17, 2010, now Pat. No. nese intoxication, using Substantially continuous administra 8,193,243. tion of levodopa and/or carbidopa or ester and/or salt thereof.
    [Show full text]
  • Development and Validation of a UHPLC-UV Method for The
    Development and validation of a UHPLC-UV method for the detection and quantification of erectile dysfunction drugs and some of their analogues found in counterfeit medicines. Pierre-Yves Sacré a,b, Eric Deconinck a, Patrice Chiap c, Jacques Crommen b, François Mansion b, Eric Rozet d, Patricia Courselle a, Jacques O. De Beer a,* a Laboratory of Drug Analysis, Scientific Institute of Public Health, Brussels, Belgium b Department of Analytical Pharmaceutical Chemistry, Institute of Pharmacy, University of Liège, Liège, Belgium. c Advanced Technology Corporation (A.T.C.), University Hospital of Liège, Liège, Belgium d Department of Analytical Chemistry, Institute of Pharmacy, University of Liège, Liège, Belgium. Abstract Pharmaceutical counterfeiting is a permanently growing problem. Control laboratories are constantly analysing counterfeit medicines. In industrialised countries, one of the main counterfeited class of medicines are erectile dysfunction drugs. This paper describes the development and validation of a fast method to detect and quantify the three authorised phosphodiesterase type 5 inhibitors and five analogues. The method is based on the use of a sub-2 microns polar-embedded column with a gradient using acetonitrile as organic modifier and 10 mM ammonium formate buffer (pH 3.5) as aqueous component of the mobile phase. The separation was achieved in less than 4.5 min. The method has also been compared to the registered HPLC method for the assay of Viagra ® which was considered as the reference method. The method is also compatible with on-line coupling mass spectrometry and will significantly reduce analysis times and solvent consumption. Keywords: Phosphodiesterase type 5 inhibitors; UHPLC; method validation, analogues, counterfeit drugs, accuracy profiles.
    [Show full text]
  • NDPSC Record of Reasons, Meeting 37, Feb 2003
    National Drugs and Poisons Schedule Committee Record of the Reasons 37th Meeting 25-26 February 2003 The Record of the Reasons contains the basis of scheduling decisions and other outcomes arising from the meeting. Please note that the Record of the Reasons includes extracts from the NDPSC minutes which have been edited to remove confidential information. National Drugs and Poisons Schedule Committee Record of the Reasons Meeting 37 - February 2003 i TABLE OF CON TEN TS GLOSSARY.........................................................................................................................IV 2. PROPOSED CHANGES/ADDITIONS TO PARTS 1 TO 3 AND PART 5 OF THE STANDARD FOR THE UNIFORM SCHEDULING OF DRUGS AND POISONS. ........................9 2.1 SUSDP, PART 1 ..........................................................................................................9 2.2 SUSDP, PART 2 ..........................................................................................................9 2.3 SUSDP, PART 3 ..........................................................................................................9 2.3.1 Organotin Compounds...........................................................................................9 2.4.1 BORON TRIFLUORIDE, BIFLUORIDES AND HYDROSILICOFLUORIC ACID – APPENDIX F PART 3 ...9 AGRICULTURAL/VETERINARY, INDUSTRIAL AND DOMESTIC CHEMICALS.................. 11 3. MATTERS ARISING FROM THE MINUTES OF THE PREVIOUS MEETING (CONSIDERATION OF POST-MEETING SUBMISSIONS UNDER 42ZCZ).............................
    [Show full text]
  • Download PDF File
    Ginekologia Polska 2019, vol. 90, no. 9, 520–526 Copyright © 2019 Via Medica ORIGINAL PAPER / GYNECologY ISSN 0017–0011 DOI: 10.5603/GP.2019.0091 Anti-androgenic therapy in young patients and its impact on intensity of hirsutism, acne, menstrual pain intensity and sexuality — a preliminary study Anna Fuchs, Aleksandra Matonog, Paulina Sieradzka, Joanna Pilarska, Aleksandra Hauzer, Iwona Czech, Agnieszka Drosdzol-Cop Department of Pregnancy Pathology, Department of Woman’s Health, School of Health Sciences in Katowice, Medical University of Silesia, Katowice, Poland ABSTRACT Objectives: Using anti-androgenic contraception is one of the methods of birth control. It also has a significant, non-con- traceptive impact on women’s body. These drugs can be used in various endocrinological disorders, because of their ability to reduce the level of male hormones. The aim of our study is to establish a correlation between taking different types of anti-androgenic drugs and intensity of hirsutism, acne, menstrual pain intensity and sexuality . Material and methods: 570 women in childbearing age that had been using oral contraception for at least three months took part in our research. We examined women and asked them about quality of life, health, direct causes and effects of that treatment, intensity of acne and menstrual pain before and after. Our research group has been divided according to the type of gestagen contained in the contraceptive pill: dienogest, cyproterone, chlormadynone and drospirenone. Ad- ditionally, the control group consisted of women taking oral contraceptives without antiandrogenic component. Results: The mean age of the studied group was 23 years ± 3.23. 225 of 570 women complained of hirsutism.
    [Show full text]
  • PSP: Some Answers
    PSP: Some Answers Lawrence I. Golbe, MD Professor of Neurology, Rutgers Robert Wood Johnson Medical School Director of Clinical Affairs and Scientific Advisory Board Chairman, CurePSP October 2017 What is Progressive Supranuclear Palsy (PSP)? Of the approximately five to seven of every 100,000 people in Canada with progressive supranuclear palsy (PSP), few, if any, had ever heard of the disease before their diagnosis. In fact, most patients with PSP report that their family doctors knew nothing about it until a neurologist made the diagnosis. As of now, three of every four people with a diagnosis of PSP could have been diagnosed earlier, if their doctor had suspected it and performed the appropriate examination. However, it is appearing in medical journals more and more often, which will help doctors become familiar with PSP. This pamphlet should help patients and their families do the same. Why has no one heard of PSP? PSP is rare: no one even realized it existed until 1963, when several patients were first described at a national neurology research convention and the disease was given its name. In retrospect, at least 12 cases of PSP had appeared in the medical literature between 1909 and 1962, but because of its resemblance to Parkinson’s, it wasn’t recognized as a distinct disease. The brain under the microscope is almost identical to that of “post-encephalitic parkinsonism,” a common condition in the early 20th century but now nearly extinct, which also made for erroneous diagnoses during that era. Although PSP is slightly more common than the well-known amyotrophic lateral sclerosis (called ALS, or Lou Gehrig’s disease in the U.S.
    [Show full text]
  • ED Analogues Analysis
    UPLC-MS/MS for the Screening, Confirmation and Quantification of 32 Drugs illegally added to Herbal/Dietary Supplements for the Enhancement of Male Sexual Performance 1Salman Azimi*, 2Nayan Mistry and 2Michelle Wood 1Drug Quality Control Laboratory, Pharmacy & Drug Control Dept., Supreme Council of Health, PO Box 1919, Doha - Qatar. 2 Figure-5: Photographs of six positive samples. Forty-three suspected Waters Corporation, Atlas Park, Wythenshawe, Manchester, M22 5PP, UK. samples were analyzed in this study; 18 were found to be adulterated with ED drugs. ABSTRACT RESULTS & DISCUSSION The adulteration of herbal/dietary supplements with erectile dysfunction (ED) drugs and their analogues is reported For the purpose of screening , a spectral library for known ED drugs and analogues was prepared. Owing to recent reports Table 2: List of 32 compounds with retention times, and optimised MRM transitions parameters. Table-3: Summary of results for eight adulterated herbal/dietary samples. The screening results, including spectral match worldwide and is an increasing problem[1]. The sale of so-called 100%, ‘all-natural’ products has become a highly of increased availability of ‘all-in-one’/ ‘combination’ herbal products[2], we also added the naturally-occurring substances factors, RT data and final screening status ( = positive or - = negative) are presented, in addition to the quantitative data Retention Precursor Cone Quantifier Qualifier %CV (n=4) from the subsequent confirmatory analysis. profitable business for online pharmacies, however these products can pose a serious threat to consumers owing to the Icariin and yohimbine, the synthetic, dapoxetine (used for premature ejaculation) and testosterone. The library was CE CE Dwell LOQ undisclosed presence of approved/prescription drugs or the unknown safety and toxicity profile of unapproved ED drugs.
    [Show full text]
  • Azilect, INN-Rasagiline
    SCIENTIFIC DISCUSSION 1. Introduction AZILECT is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. Rasagiline is administered orally, at a dose of 1 mg once daily with or without levodopa. Parkinson’s disease is a common neurodegenerative disorder typified by loss of dopaminergic neurones from the basal ganglia, and by a characteristic clinical syndrome with cardinal physical signs of resting tremor, bradikinesia and rigidity. The main treatment aims at alleviating symptoms through a balance of anti-cholinergic and dopaminergic drugs. Parkinson’s disease (PD) treatment is complex due to the progressive nature of the disease, and the array of motor and non-motor features combined with early and late side effects associated with therapeutic interventions. Rasagiline is a chemical inhibitor of the enzyme monoamine oxidase (MAO) type B which has a major role in the inactivation of biogenic and diet-derived amines in the central nervous system. MAO has two isozymes (types A and B) and type B is responsible for metabolising dopamine in the central nervous system; as dopamine deficiency is the main contributing factor to the clinical manifestations of Parkinson’s disease, inhibition of MAO-B should tend to restore dopamine levels towards normal values and this improve the condition. Rasagiline was developed for the symptomatic treatment of Parkinson’s disease both as monotherapy in early disease and as adjunct therapy to levodopa + aminoacids decarboxylase inhibitor (LD + ADI) in patients with motor fluctuations. 2. Quality Introduction Drug Substance • Composition AZILECT contains rasagiline mesylate as the active substance.
    [Show full text]
  • Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017
    Q UO N T FA R U T A F E BERMUDA PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 BR 111 / 2017 The Minister responsible for health, in exercise of the power conferred by section 48A(1) of the Pharmacy and Poisons Act 1979, makes the following Order: Citation 1 This Order may be cited as the Pharmacy and Poisons (Third and Fourth Schedule Amendment) Order 2017. Repeals and replaces the Third and Fourth Schedule of the Pharmacy and Poisons Act 1979 2 The Third and Fourth Schedules to the Pharmacy and Poisons Act 1979 are repealed and replaced with— “THIRD SCHEDULE (Sections 25(6); 27(1))) DRUGS OBTAINABLE ONLY ON PRESCRIPTION EXCEPT WHERE SPECIFIED IN THE FOURTH SCHEDULE (PART I AND PART II) Note: The following annotations used in this Schedule have the following meanings: md (maximum dose) i.e. the maximum quantity of the substance contained in the amount of a medicinal product which is recommended to be taken or administered at any one time. 1 PHARMACY AND POISONS (THIRD AND FOURTH SCHEDULE AMENDMENT) ORDER 2017 mdd (maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours. mg milligram ms (maximum strength) i.e. either or, if so specified, both of the following: (a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or (b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w, or v/v, as appropriate.
    [Show full text]
  • 2251 Adulteration of Dietary Supplements with Drugs
    BRIEFING 2251 Adulteration of Dietary Supplements with Drugs and Drug Analogs. This new general chapter provides tools for detection of dietary supplement adulteration with ⟨extraneously⟩ added synthetic compounds. The illegal addition of synthetic substances to products marketed as dietary supplements constitutes a significant threat to consumer health, considering that these products, administered without medical supervision, may contain toxic constituents or substances whose safety has never been examined, and whose interaction with medications may be unpredictable or lethal. The proposed chapter suggests multiple methods for detection of adulteration. It is advisable to use several screening techniques to maximize the potential for adulteration detection, because no single methodology is universally applicable. Presently, the chapter targets supplements adulterated with phosphodiesterase type 5 inhibitors; subsequent revisions will include methodologies specific to analysis of adulterated weight loss and sports performance enhancement products. It is anticipated that this chapter will be updated regularly. (GCCA: A. Bzhelyansky.) Correspondence Number—C144928 Add the following: ▪ 2251 ADULTERATION OF DIETARY SUPPLEMENTS WITH DRUGS AND DRUG ANALOGS ⟨ ⟩ INTRODUCTION The illegal addition of undeclared synthetic compounds to products marketed as dietary supplements1 (DS) is a serious problem. This fraud is practiced to impart therapeutic effects that cannot be achieved by the supplement constituents alone. Increasingly, synthetic intermediates and structural analogs of the pharmaceuticals and drugs that have been discontinued or withdrawn from the market due to unsatisfactory safety profiles are being used as adulterants. Multiple adulterating compounds may be added to a single DS, frequently in erratic amounts. The proposed test methodologies facilitate screening of DS for synthetic adulterants. No individual technique is capable of addressing all potential analytes; thus, a combination of orthogonal approaches adds certainty to the analytical outcome.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,675,619 B2 Fossel (45) Date of Patent: *Jun
    USOO9675619B2 (12) United States Patent (10) Patent No.: US 9,675,619 B2 FOSSel (45) Date of Patent: *Jun. 13, 2017 (54) TREATMENT OF ERECTILE DYSFUNCTION 31/198 (2013.01); A61K 31/495 (2013.01); AND OTHER INDICATIONS A6 IK3I/4985 (2013.01); A61K 3 1/506 (2013.01); A61 K3I/519 (2013.01); A61 K (71) Applicant: Strategic Science & Technologies, 47/02 (2013.01); A61K 47/06 (2013.01); A61 K LLC, Cambridge, MA (US) 47/10 (2013.01); A61K 47/12 (2013.01); A61 K 47/14 (2013.01); A61K 47/16 (2013.01); A61 K (72) Inventor: Eric T. Fossel, Cambridge, MA (US) 47/183 (2013.01); A61K 4 7/22 (2013.01); A61K 47/26 (2013.01); A61K 47/36 (2013.01) (73) Assignee: Strategic Science & Technologies, (58) Field of Classification Search LLC, Cambridge, MA (US) CPC .............. A61K 2300/00; A61K 31/198; A61 K (*) Notice: Subject to any disclaimer, the term of this 31/.495; A61K 3 1/506; A61K 31/519; patent is extended or adjusted under 35 A61K 3 1/53: A61K 9/0014; A61 K U.S.C. 154(b) by 0 days. 31/4985; A61K 47/02: A61K 47/10; A61K 47/16; A61K 47/183: A61K 47/22: This patent is Subject to a terminal dis A61K 47/26: A61K 47/06; A61K 47/12: claimer. A61K 47/14: A61K 47/36; A61K 9/0034; A61K 9/06; A61K 9/107 (21) Appl. No.: 15/290,504 USPC ............................................................ 424/45 See application file for complete search history. (22) Filed: Oct.
    [Show full text]
  • Etats Rapides
    List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate
    [Show full text]