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Pharmaceutical Secondary Standards

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PharmaceuticalSecondaryStandardsThe life science business of Merck KGaA,Darmstadt, Germany operates asMilliporeSigma in the U.S. and Canada.2017 - 06212 - Secondary Standards brochure MSIG.indd 113/06/18 1:32 PM

MilliporeSigma’s pharmaceutical secondary standards providepharmaceutical laboratories and manufacturers with a convenient andcost effective alternative to making in-house working standards.The US Food and Drug Administration (FDA), United StatesPharmacopeia (USP) and European Pharmacopoeia (EP) all recognizethe use of secondary standards, or working standards, which areestablished with reference to the corresponding primary standard(references available on request). Using these commercially availablesecondary standards allows you to focus resources on core businessactivities, rather than consuming time and resources preparing internalworking standards. In addition, our secondary standards provide largerquantities at less expense.The most important product features are: Traceability to United States Pharmacopeia (USP)and also to European Pharmacopoeia (EP) and BritishPharmacopoeia (BP) standards where available. Analysis is performed using instruments validatedaccording to GMP using pharmacopeia monographmethods Certified purity value according to ISO Guide 34 andISO/IEC 17025 using mass balance approach Comprehensive certificate according to ISO Guide 31Our secondary standards are offered as certifiedreference materials (CRMs) produced in an ISO/IEC17025 and ISO Guide 34 accredited facility. Theircomprehensive certificates supply values for theshipped material demonstrating traceability to USP,EP and BP primary standards (the latter two occurringwhen a corresponding primary CRS (certified referencesubstance) is available).In addition, an independent certified purity value isgiven. This allows the secondary standards to be usedas reference materials for quantitative uses.Comprehensive CertificateOur certificate for these pharmaceutical secondarystandards consists of up to 8 pages and containstraceability assay results, certified purity as well asinformation about analytical methods, chromatogramsand additional analytical data. Example certificatesare available for free download on the web(SigmaAldrich.com/pharmastandards). An examplehow the pharmacopeia traceable values are reported inthe certificate is shown in Figure 1 on page 3.The values on the certificate are always traceable tothe current Pharmacopeial lots. If a valid Pharmacopeiallot changes, then our corresponding PharmaceuticalSecondary Standard will be recertified with traceabilityto the new lot and a new certificate will be madeavailable online. For this reason, the valid certificatealways needs to be downloaded from the website priorto use of the material.Please note the following: The Reference Standards ofthe Pharmacopeial authorities are for the specified usedescribed in the monograph. The use of the standardbeyond that limited scope is not supported by thePharmacopeia. Other data supplied in the certificate ofsecondary standards is for informational purposes onlyand does not support Pharmacopeial use beyond thatstated in the corresponding monograph.The comprehensive certificate contains thefollowing data and information: Handling and storage instructions Traceability results versus Pharmacopeial primarystandards Certified purity value by mass balance(according to ISO/IEC 17025) Comprehensive additional analytical data22017 - 06212 - Secondary Standards brochure MSIG.indd 213/06/18 1:32 PM

Traceability Assay ResultsAssay vs. USP Reference Standard (as is basis)Comparative assay demonstrates direct traceabilityto Pharmacopeial StandardsSpecification: 97.0–103.0% (anhydrous, USP/NF)98.5–101.0% (dried substance, EP)Determination Method: HPLC(ref., Current Compendial Monograph: Ibuprofen)Column: Ascentis C18, 4.6 x 250mm, 5µm2Mobile Phase: Acetonitrile/Water/Chloroacetic acid(600:400:4)Column Temperature: 30 CFlow Rate: 2 mL/minInjection: 5 µl1Assay Value99.5%5vs. USP LOT4R024X0Labeled Content 0.998 mg/mg1Analytical specification2Reference to Pharmacopeial monograph (if available) used forthe certification3Analytical conditions of the method used4Reference to the Pharmacopeial lot of the primary standard5Assay value (traceable to the given Pharmacopeial lot)3Detector Wavelength: 254 nmFigure 1: Certificate excerpt of traceability assay results (vs the USP reference standard) for Ibuprofen (PHR1004).The following list contains our catalog of over 700 products and shows thePharmacopeial CRS to which they are traceable. Our portfolio of pharmaceuticalsecondary standards is continually growing:Please visit our website at SigmaAldrich.com/pharmastandards for an up-to-dateproduct listing.Please also have a look at our offering of pharmaceutical impurity standardsSigmaAldrich.com/pharmaimpurities and pharmaceutical proficiency testingmaterials SigmaAldrich.com/ptpharma32017 - 06212 - Secondary Standards brochure MSIG.indd 313/06/18 1:32 PM

Pharmaceutical Secondary StandardsCustom ServicesLet us partner with your organization to providemanufacturing and packaging services customized toyour specifications. Our scopes of accreditation includea broad range of technologies and competencies,ensuring that custom projects can be accommodatedand with the highest quality. Your projects will beprocessed in a dedicated clean room productionfacility and under cGMP conditions appropriate to themanufacturing of reference materials. We can supply custom reference materials basedon your specific needs and following your requiredspecifications. These materials can be qualified andcharacterized at our Laramie Wyoming USA facilityand can be supplied as Certified Reference Materialsin accordance with ISO Guide 34 and ISO/IEC 17025.Monthly COA UpdatesCustomers are notified in advanceof any COA changes that may occurdue to re-qualification etc. Thisservice helps users ensure thatthey always have the most currentversion of a product certificate.Sign up for these email updates on our website at SigmaAldrich.com/pharmastandards We can supply packaging services customized to yourspecifications. We currently offer packaging servicesfor both solids and liquids and have blister packagingcapabilities.CapabilitiesNow AvailablePowder DispensingPrimary Pharmaceutical Standards Serum vials: multiple sizes, crimp cap, fluoropolymerstoppersA primary standard in metrology is a standard thatis accurate enough that it is not calibrated by orsubordinate to other standards. In a pharmaceuticalsetting, primary standards are produced and suppliedby scientific organizations such as the EDQM (EuropeanPharmacopoeia) and the US Pharmacopeia. Glass/plastic bottles HEPA filtered clean-room dispensing cabinetsNow, we provide a stress-free, time-saving and efficientroute to procuring USP, EP and BP standards. Followingfull compliance checks, these are available for easyordering either through the web or following your usualB2B purchasing routes. Low actinic light control Automated powder filling Screw cap vials Anaerobic GloveboxA large number of these reference materials are currentlyheld in stock in our warehouses, and MilliporeSigma hasa major program to increase this week on week. Our webpages provide live stock levels and those not in stock willgenerally be delivered in 3–4 weeks.Liquid DispensingUse of Primary Pharmaceutical Standards Automated flame-sealed ampulingThe use of primary reference standards is prescribed bythe issuing pharmacopeia. Clean room dispensing suites Humidity control Inert gas overlay Amber or clear ampules: 2, 5, 10, or 20 mLPackaging Solids/Liquids Toxic materials Flammable materials Light sensitive Oxygen sensitive Hygroscopic materialsUSP Reference Standards are intended only for use inanalytical or laboratory applications as specified in USPcompendia.EP Materials are supplied exclusively as EuropeanPharmacopoeia Chemical Reference Substances, BiologicalReference Preparations or Reference Spectra (Ph. Eur.CRS, BRP or RS) for use as reference standards in testsand assays carried out in accordance with the officialmethods of the European Pharmacopoeia (Ph. Eur.) andfor no other purpose.View our complete offering of primary pharmaceuticalstandards atSigmaAldrich.com/pharmaceuticalstandards42017 - 06212 - Secondary Standards brochure MSIG.indd 413/06/18 1:32 PM

Traceable toCat. pan-2-ol) (Fluconazole Related Compound A)Package SizeUSP No.EP No.BP No.30 propanoic acid (Ibuprofen Impurity B)20 l]propanoic acid (Ibuprofen Impurity A)20 ridine-2-carboxamide (Bupivacaine Impurity B)20 yl-3-(pyridin-2-yl)propan-1-amine maleate)(Chlorpheniramine Related Compound C)50 e 1-oxide) (Omeprazole Related Compound I)30 ylpyridine 1-oxide) (Omeprazole Related Compound E)30 ro-6-(propylamino)benzothiazole dihydrochloride(Pramipexole Related Compound D)50 nyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acidethyl ester dihydrochloride (Cetirizine hydrochloride Related Compound A)40 oxy)-3,4-dihydroquinolin-2(1H)-one (Cilostazol Related Compound C)100 1,2,4-Triazole) (Fluconazole Related Compound C)20 —PHR15491,4-Dioxane3 1.2 ne(Nevirapine Related Compound A)50 esonide Related Compound L)50 thyl]phenyl]sulfonyl]urea (Glipizide Related Compound C)3 1.2 mL1081807——50 mg1292631——PHR15051-Methylbiguanide hydrochloride (Metformin Related Compound B)50 mg1396331——PHR12171-Pentanol3 1.2 mL1504955——PHR12081-Propanol3 1.2 mL1570406——PHR17401-Vinyl-2-pyrrolidinone200 diol (Guaifenesin Imp B)50 2,4-triazol-1-yl)-propan-2-ol (Fluconazole RelatedCompound B)20 thylphenyl)acetamide Hydrochloride (LidocaineRelated Compound I)100 phenyl)acetamide Hydrochloride (LidocaineRelated Compound J)100 mg———PHR16702-(diethylazinoyl)-n-(2 6-dimethylphenyl)acetamide (Lidocaine Related Compound B)100 ophenone hydrochloride (Bupropion HydrochlorideRelated Compound B)30 oropopiophenone hydrochloride (BupropionHydrochloride Related Compound A)30 imethylphenyl)acetamide] (Lidocaine RelatedCompound E)100 mg———PHR19152,2,4-Trimethylpentane (Isooctane)PHR16472,2’-Dipyridylamine (Chlorpheniramine Related Compound B)3 1.2 mL———200 mg———PHR15742,2-Diphenylglycine (Phenytoin Related Compound A)100 mg1535019——PHR13682,3-Dichlorobenzoic acid (Lamotrigine Related Compound B)100 -phenylpteridine (Triamterene Related Compound C)100 mg1680030——PHR16692,6-Dimethylaniline (Lidocaine Related Compound A)100 eridine (Triamterene Related Compound B)100 )phenyl]propanoic acid (Ibuprofen Impurity J)50 e salt (Ranitidine Related Compound A)100 mg1598507——52017 - 06212 - Secondary Standards brochure MSIG.indd 513/06/18 1:32 PM

Pharmaceutical Secondary StandardsTraceable toCat. No.DescriptionPackage SizeUSP No.EP No.BP No.PHR16712’,6’-Dimethylacetanilide (Lidocaine Related Compound C)100 mg———PHR15312-Acetamidophenol (Acetaminophen Related Compound C)200 200 mg1022808——PHR17392-Aminophenol (Mesalazine Impurity C)200 mg—Y0001569—PHR15632-Butanol3 1.2 mL1081829——PHR17412-Chloro-5-nitrobenzoic Acid200 e Imp E)500 mg—Y0000279—PHR15502-Ethoxyethanol3 1.2 mL1601543——PHR19142-Ethylhexanoic acid3 1.2 mL———PHR17422-Hydroxy-nitrobenzoic acidPHR15442-Methoxyethanol200 mg———3 1.2 mL1601645——PHR11952-Methyl-5-nitroimidazole; Tinidazole Related Compound A500 mg1667530Y0000087—PHR11812-Methylimidazole (Ondansetron Imp F)500 mg—Y0001320—PHR12232-Methylpyrazine500 fonic acid (Ensulizole)PHR10722-Propanol1g1530809——3 1.2 mL1570428——PHR13033,4,4 Trichlorocarbanilide (Triclocarban)500 mg———PHR11943,4-Dimethoxybenzaldehyde (Verapamil Related Compound E)500 mg1711439——500 mg1711440——30 mg———500 mg1570450——PHR11933,4-Dimethoxybenzyl alcohol (Verapamil Related Compound F)PHR19643-[4-(2-methylpropyl)phenyl]propanoic acid (Ibuprofen Impurity F)PHR13393-Amino-1-propanolPHR17433-Aminobenzoic acid200 mg———PHR17443-Chlorobenzoic acid200 mg1112299——PHR13543-Iodo-2-propynyl N-butylcarbamate500 083100———PHR15684-(Trifluoromethyl)aniline (Leflunomide Related Compound A)200 inone (Gabapentin Related Compound A)100 ide(Celecoxib Related Compound B)20 elecoxib Related Compound A)20 mg1098515——PHR16124'-Acetoxyacetanilide (Acetaminophen Related Compound A)50 disulfonamide; Benzothiadiazine Related Compound A500 mg1057507——200 oacetophenonePHR11484-Aminophenol (Acetaminophen Related Compound K)PHR17454-Aminophenol Hydrochloride500 mgPHR17464-Aminosalicylic acid500 ophen Related Compound J)1g1003100——100 ydrotetracycline HydrochloridePHR10484-Hydroxybenzoic AcidPHR16434-Hydroxyisophthalic acid (Salicylic Acid Related Compound B)200mg1609024Y0000405—PHR11464-Isobutyl Acetophenone(Ibuprofen Related Compound C)500 mg1335541——PHR11504-Nitrophenol (Acetaminophen Related Compound 6-one(Nevirapine Related Compound C)50 yrido[3,2-b:2’,3’-e][1,4]diazepin-6-one (NevirapineRelated Compound B)50 ryptylene Related Compound B)50 nyl)hexanamide (Bupivacaine Impurity E)1 ml———40 mg1078518Y0000089—62017 - 06212 - Secondary Standards brochure MSIG.indd 613/06/18 1:32 PM

Traceable toPackage SizeUSP No.EP No.BP No.100 mg1134175——Cat. l-5-yl)-butoxy]-1H-quinolin-2-one (CilostazolRelated Compound ol (Pyridoxine Impurity A)50 phenyl)ethyl]pyrazine-2-carboxamide (GlipizideRelated Compound B)50 mg1292610Y0000643—PHR17196-O-Methylguanine (2-Amino-6-Methoxypurine)PHR1256Abacavir Sulfate1g———500 mg1000408——PHR1253Acarbose500 mg—Y0000500—PHR1266Acesulfame Potassium500 mg1002505A0070000—1g1003009P030000371PHR1612 - 4'-Acetoxyacetanilide (Acetaminophen Related Compound A)50 mg1003010——PHR1642 - N-(4-Hydroxyphenyl)Propanamide (Acetaminophen Related Compound B)50 mg1003027——PHR1531 - 2-Acetamidophenol (Acetaminophen Related Compound C)200 mg1003031——PHR1530 - Acetanilide (Acetaminophen Related Compound D)200 mg1003042——PHR1150 - 4-Nitrophenol (Acetaminophen Related Compound F)1g1003064——PHR1149 - 4-Chloroacetanilide(Acetaminophen Related Compound J)1g1003100——PHR1148 - 4-Aminophenol (Acetaminophen Related Compound K)1g1021204——Acetanilide Melting Point Standard1g1004001——PHR1005Acetaminophen (Paracetamol)Related Compounds:PHR1086PHR1530Acetanilide (Acetaminophen Related Compound D)200 mg1003042——PHR1219Acetone3x1.5 mL1006801——PHR1551Acetonitrile3x1.2 mL1601340———PHR1546Acetylcholine chloride500 mg1008501Y0000002PHR1156Acetyltributyl Citrate1g1009901Y0001055—PHR1157Acetyltriethyl 8Adapalene500 endazole1g1012553A0325100763PHR1053Albuterol 1.2 mL1012768E1860100—Alendronate Sodium1g1012780Y0001727—PHR1638Alfuzosin 00 mg1012939A0349000—1g1013002A0350000870500 mg1667600T1550000882PHR1377AllopurinolPHR1031alpha -TocopherolPHR1030alpha -Tocopheryl Acetate500 mg1667701T1600000—PHR1029alpha -Tocopheryl Acid Succinate500 mino)-alpha-phenyl benzeneacetic acid (PhenytoinRelated Compound B)100 501Aminobutanol1g1020008——PHR1224Aminocaproic Acid1g1021000A0420000—PHR1164Amiodarone ine HClPHR1783Anastrozole1g1029002Y000056316500 mg1034807——50 mg1029024——Related Compounds:PHR1776 - o[a,d]cyclohepten-5-ol (Amitryptylene Related Compound B)72017 - 06212 - Secondary Standards brochure MSIG.indd 713/06/18 1:32 PM

Pharmaceutical Secondary StandardsTraceable toCat. No.DescriptionPackage SizeUSP No.EP No.BP No.PHR1185Amlodipine Besylate1g1029501Y0000049—PHR1327Ammonium Chloride1g1029953——PHR1689Ammonium Glycyrrhizate200 mg1029929G0460000—PHR1127Amoxicillin Trihydrate1g1031503A080000019PHR1662Amphotericin B500 mg1032007Y0000005—PHR1424Ampicillin Sodium1g1033203A1000000785PHR1393Ampicillin 1g—Y0001244—PHR1218Anethole2.2 mL1035005——PHR1212AnisolePHR1677Anthralin (Dithranol)PHR1454Arginine HydrochloridePHR1784AripiprazolePHR1008Ascorbic Acid3x1.2 71000500 mg1042634Y0001649—2g1043003A1300000461PHR1708 - D-sorbosonic acid (Ascorbic acid Imp C)30 mg—Y0001024—PHR1709 - Methyl-D-Sorbosonate (Ascorbic Acid Imp D)30 mg—Y0001170———Related Compounds:PHR1433Ascorbyl Glucoside1g—PHR1455Ascorbyl 3706A1320000—PHR1003Aspirin (Acetylsalicylic acid)1g1044006A0200000617500 mg———1g1044516Y0001327—500 oxetine HydrochloridePHR1422Atorvastatin CalciumPHR1591AtovaquonePHR1379Atropine hioprine1g1046001A1500000—PHR1636Azelastine in1g1046056Y0000306—PHR1785Aztreonam500 1559Bacitracin 1619Beclomethasone 3x1 mL1050905——PHR1371Benzalkonium Chloride 10% Solution5 mL1051001——PHR1681Benzalkonium Chloride 50% Solution1 5Benzethonium 4000B0600000—PHR1050Benzoic 7—PHR1712Benzylphenylephrone (Phenylephrine Re

USP Reference Standards are intended only for use in analytical or laboratory applications as specified in USP compendia. EP Materials are supplied exclusively as European Pharmacopoeia Chemical Reference Substances, Biological Reference Preparations or Reference Spectra (Ph. Eur. CRS, BRP or RS) for use as reference standards in tests