Compounds that are susceptible to hydrolysis, for example, should be thoroughly dried to remove moisture and then stored in a desiccator. Buy Fenofibrate Related Compound C USP compendial standard (CAS 217636-48-1) to determine strength, quality, purity and identity in your USP-NF monograph tests and assays. If residual solvents (previously referred to as organic volatile impurities, or OVIs, by USP) are proven to be less than the reporting threshold at initial characterization, further analysis is generally not required at subsequent intervals. This timeframe will also help to avoid delays in testing for subsequent programs due to an expired reference standard. Something went wrong, please try again later. Errors and Corrections Different types of reference-standard materials and the qualification tests recommended are presented in Table II. Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USPNF. Visit the USP Reference Standards Catalog and the online USP Store for a complete listing of available USP RS's and to obtain RS documentation (e.g., USP Certificates, SDS), lot validity, and more. Once the storage conditions are ascertained, the reference-standard material should be monitored continually using a suitable environmental monitoring system. The analytical method is therefore qualified for use but not validated per ICH guidelines. If you accept without changing your settings, we assume that you are happy to receive all cookies on the LGC website. Explore our reference standards supporting COVID-19 testing. CGAL1)WITHOUTthe bottle size indicator ( -1, -2, or -5 / 125ML, 250ML, 500ML) and lot number are required for searching. To receive periodic email updates when USP posts New Official Text, sign up for the free Compendial Updates service. Promoting the Quality of Medicines Plus (PQM+) Program, https://go.usp.org/e/323321/tos/6dkrbs/418244431?h=qr1jIlTy9Nc1_AEosizz, The United States Pharmacopeial Convention. United States Pharmacopeia (USP) Reference Standard Synonym (s): [Arg8]-Vasopressin, Argipressin Empirical Formula (Hill Notation): C46H65N15O12S2 CAS Number: 113-79-1 Molecular Weight: 1084.23 Pricing and availability is not currently available. This level may be insufficient to affect overall purity results. H2O CAS Number: 86393-32- Molecular Weight: 385.82 MDL number: MFCD00242856 PubChem Substance ID: 329749408 NACRES: NA.24 Pricing and availability is not currently available. Impurities that arise from raw materials, synthesis, purification, and storage require careful consideration because they may not produce detector responses that are related to the reference-standard material. Training resources and our customer support experts are just a few taps away. Properties grade pharmaceutical primary standard manufacturer/tradename USP application (s) Based on the results, the material may require further purification by distillation or recrystallization. Properties pharmaceutical primary standard Have questions about our reference standards? In addition, USP reference standards are considered suitable for use up to one year after a new lot is released. : {{entry.product.biosafetyLevel == -1 ? The USP APP utilizes a third-party Barcode App. All rights reserved. Each of these factors must be considered in the development of a comprehensive reference-standard material program. 5. Certificate of Analysis (COA) Search Both the core name (ex. 2023 MJH Life Sciences and Pharmaceutical Technology. Inorganic impurities. Designing Potency Assays for Complex Novel Modalities, Bio-Rads New StarBright Blue and Yellow Dyes Enhance Multiplex Flow Cytometry, Eurofins Viracor Launches Test for Assessing Expansion and Persistence of CAR-T Therapy in Cancer Patients, Assaysused to determine potency for active pharmaceutical ingredients (APIs) and salts, Degradation productsused to identify and possibly to quantitate degradation products, Process impuritiesused to identify and possibly quantitate process-related compounds, Resolutionused to determine assay performance or impurity method. Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. Please note that this product is not available in your region. Regulatory agencies will accept reference-standard materials from a pharmacopeial source and NIST without further qualification (1). For information relating to LGCs data processing activities, please visit our Privacy Policy below (see footer). 1. The USP Reference Standards Laboratory (see, Reference Standards are specifically required in many Pharmacopeial assays and tests and are provided solely for such use; suitability for other nonofficial application(s) rests with the purchaser. David Browne is manager of stability and pharmaceutical testing at Intertek Pharmaceutical Services, d/b/a QTI, 291 Route 22 East, Whitehouse, NJ 08888, tel. Find your frequently-used reference standards with ease use our bookmarking tool. The technique used to obtain this data will depend on the amount of impurities and related compounds present and the decomposition pathway of the reference-standard material. You will also receive alerts about product launches, back orders or system outages. USP may make improvements and/or changes to its features, functionality or Content at any time. Reference-standard materials that are synthesized by the user or supplied by a contract manufacturer or secondary company must be characterized (3). Product code: {{entry.product.displayPartCode ? . Foods Download the list as: EXCEL | PDF Pharmaceutical Analytical Impurities These tests and procedures often require the use of official USP physical reference standards. The USP Reference Standards Committee collaborates closely with the WHO in order to minimize unavoidable differences in the actual units of potency, and in some cases to share in the preparation of a reference standard. An insufficiently characterized reference standard may delay or prevent FDA approval of a drug product to market. This article addresss chemical reference standards only. 2. Advances in analytical methods, manufacturing processes and digital innovations are changing the science of how medicine quality is assessed and maintained. Ordinarily the previous lot is carried in official status for about one year after the current lot entered distribution unless, because of a change in monograph requirements or stability limitations, the previous lot is found to be no longer suitable. To serve its intended purpose, each USP Reference Standard must be properly stored, handled, and used. Download the list of New Impurities & New IP Reference standards: The Indian Pharmacopoeia Commission (IPC) has added 23 new impurities standards and 7 new Indian Pharmacopoeial Reference standards. These two sections are reprinted here for your reference. : US 2013/0252924 A1 Penninger Et Al, Potential Therapeutic Targets of Guggulsterone in Cancer Ajaz A, Commiphora Wightii (Arnott) BhandariA Natural Source of Guggulsterone: Facing a High Risk of Extinction in Its Natural Habitat, MOL 7054 1 the Hypolipidemic Natural Product Guggulsterone Is A, Therapeutic Effect of Guggulsterone in Primary Cultured Orbital Fibroblasts Obtained from Patients with Graves Orbitopathy, Synthesis of Novel Farnesoid X Receptor Agonists and Validation Of, Antihypertensive Drugs Interaction with Herbal Medicine Review, The Plant Sterol Guggulsterone Attenuates Inflammation And, Fighting Cancer with Growing Complexity Robert Skopec* Researcher Analyst, Department 01, AXON, Dubnik, Slovakia, Microbial Metabolism of an Anti-Hiv and Anti-Malarial Natural Product Andrographolide, Review Article Pharmacology and Phytochemistry of Oleo-Gum Resin of Commiphora Wightii (Guggulu), Hypolipidemic Agent Z-Guggulsterone: Metabolism Interplays with Induction of Carboxylesterase and Bile Salt Export Pump Dongfang Yang University of Rhode Island, Gum Guggul Extract Significantly Increased Serum Triiodothyronine and Decreased Hepatic Lipid Peroxidation, Risks Associated with Fat Burners a Toxicological Perspective, PSYCHOACTIVE SUBSTANCES a Guide to Ethnobotanical Plants and Herbs, Synthetic Chemicals, Compounds and Products, TOX-99 Report Series: NTP Toxicity Report Series Report Series Number: 99 Official Citation: National Toxicology Program (NTP), University of Szeged Department of Pharmacodynamics and Biopharmacy, Microbial-Catalyzed Biotransformation of Multifunctional Triterpenoids Derived from Phytonutrients, Research Journal of Pharmaceutical, Biological and Chemical Sciences, Development of Ppar- Receptor Agonists As, Systematic Review of Plant Steroids As Potential Anti- Inflammatory Agents, Analytical Reference Standards 2012 800/654-1458 | 512/238-9129 | | 512/238-9129, Analysis of Nonlinear Pharmacokinetic Systems and the Nonlinear Disposition of Phenylbutazone in Equine (Horses), Chemistry and Pharmacological Profile of Guggul-A Review, Anabolic Steroids Ultimate Research Guide Vol. Simply use our extensive, alphabetical library or convenient vial barcode scanner to find exactly what you need in a matter of seconds. Appearance confirmationvisual inspection. In addition, as the reference standard ages, new unknown impurities may be detected. For example, if the intended storage condition is 28 C then the reference standard should also be stored at 20 C as a contingency. Metabolitesused to identify and possibly to quantitate substances generated through a metabolic process. USP customers worldwide use our app to improve their production processreducing errors and saving time. While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. Minimal required tests for initial characterization are typically performed using the following tests: Other tests may include chiral evaluation (HPLC with UV detection), melting point, differential scan calorimetry, and polymorph evaluation by X-ray powder diffraction. USPs Medicine Supply Map (MSM) is a graph-based predictive data model that generates insights into the upstream medicine supply chain. USP, however, labels its reference standards (assay reference standards to the nearest 0.1% and impurity reference standards to the nearest percent). All rights reserved. The information available on this Application is not part of the text of the USP-NF and does not constitute an official interpretation of such text. The synthesis of the reference standard should be evaluated to predict and identify potential impurities from raw materials. See our solutions Go to the USP Store Important Updates USP-NF New and Updated Notices New and Updated Revision Bulletins New and Updated Interim Revision Announcements LGC will process your personal data in accordance with all applicable data protection rules and regulations. The reference-standard material program, therefore, must be designed so that the material is assessed at its intended storage condition over time. You dont have to waste time flipping through countless pages of standards. Accelerated Revisions include Revision Bulletins, Interim Revision Announcements (IRAs), and Errata. However, if you would like to, you can change your cookie settings at anytime. More analytical tests must be performed, and the probability of the purity changing during the review period increases. USP was recently made aware that the barcode software has not been updated to ensure compatibility with the USP APP. If the reference standard is in a salt form, the amount of salt present must be determined so that the purity can be corrected for content. Labs, Inc. All rights reserved. In addition, this type of standard reduces the degree of systematic and random error from the combined analytical tests. Your use of Content on this Application or materials linked from this Application is at your own risk. Lot Number. The answer is a compromise based on suitable parameters for the intended application. Initial qualification and requalification. With USP Reference Standards youre getting value beyond the vial. Harmonization Stage4 includes monographs or general chapters that have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USPNF text. Requalification at subsequent points may include a reduced suite of analysis, depending on initial results. Potential degradation product also can occur as a result of storage. "Show less" : "Show more"}}, {{ product.displayPartCode || product.code }}, + {{ product.analyteName.length - 1 }} more, {{product.currentCoaLabel}}({{product.code}}), {coaEmailPopupData.isVisible = true; coaDocumentDialogVisible=false}">Email download link, COVID-19 research and reference materials. Reference standards that contain a high percentage of organic volatile impurities may experience purity changes over time as the solvents evaporate. USP Education Home / Reference Standards / Small Molecules / Associated Drug Substance / Diphenhydramine Hydrochloride (200 mg) In Stock Ready to ship $265.00 Diphenhydramine Hydrochloride (200 mg) Catalog No: 1218005 CAS RN 147-24- Molecular Formula: C17H21NO.ClH Product Type: Reference Standard Add to Cart star Add to Favorites Labs, Inc. 1985 - 2023 I.V. The total length of the requalification program will depend on the intended life of the reference standard and the length of the stability and clinical programs. Much of this information may be ascertained during the development of the drug substance. Not Legal Advice Last Updated On: November 7, 2020. The reference standard should be of the highest purity possible; the drug substance may require further purification to become a reference standard (additional purification steps used for a drug substance should be fully described and included in any regulatory filing). Table I presents recommended qualification parameters compared with reference-standard material type. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. Accepted: Sept. 22, 2008. Avoid humid storage areas in particular. Get the support you need, when you need it Have questions about our reference standards? New and Updated Interim Revision Announcements. In such instances, a specific reference standard is required for the cation, and a separate analytical method for quantitation may be needed. Please make sure there are no leading or trailing spaces as this will not return correct results. In such instances, the secondary reference standard should be qualified against the compendial reference standard. Quantitation by area percent would not be appropriate in such cases. Organic impurities. Research Publications by DISTINCTIONS Any Scientist of Pakistan in Last 10 Year and SERVICES Secretary General, the Chemical Society of Pakistan, Quantitative High-Throughput Profiling of Environmental Chemicals and Drugs That Modulate Farnesoid X Receptor, Small Molecules in Solution Has Rarely Been Reported, However, As a General Guide We Recommend Storage in DMSO at -20C, Potential of Guggulsterone, a Farnesoid X Receptor Antagonist, In, WO 2013/163758 Al 7 November 2013 (07.11.2013) P O P C T, Hepatotoxicity by Dietary Supplements: a Tabular Listing and Clinical Characteristics, Qualitative and Quantitative Estimation of Guggulsterone E and Z in Different Sodhit Guggul by LC-MS and HPLC Method, Lot Lists of Pharmacopoeias EP, EPISA, ICRS, USP, BP June 2016, Solid Phase Microbial Reactions of Sex Hormone, Trans-Androsterone with Filamentous Fungi, EP USP EPISA ICRS BP Lot List 11122015 NL.Xlsx, Predicting Drug Responses by Propagating Interactions Through Text-Enhanced Drug-Gene Networks, (12) Patent Application Publication (10) Pub. Figure 1: Decision-tree for reference-standard qualification. USP does not represent or warrant that this Application or the Content will be error-free, or that it will always be accessible. Home; Search Results. FDA, "Guideline for Submitting Samples and Analytical Data for Methods Validation" (Rockville, MD), 1987. Results {{ paginationFrom }}-{{ paginationTo }} of {{ pagination.totalResults }}, {{stcIsOpen ? How to enter Lot Number (COA) Search . 2023 MJH Life Sciences and Pharmaceutical Technology. Please enable it to use this website. Please make sure there are no leading or trailing spaces as this will not return correct results. USP currently offers more than 3,500 Reference Standardshighly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. Typically, organic impurities are identified and confirmed using liquid chromatographymass spectrometry (LGMS); nuclear magnetic resonance (NMR) and inductively coupled plasma/mass spectrometry (ICPMS) are used for inorganic impurities; and gas chromatography/mass spectrometry (LCMS) is used for residual solvents. As a reminder, the USP APP is NOT meant to be, nor is it represented as being the most up to date source of information on USP Reference Standards. Unless a Reference Standard label states a specific potency or content, the Reference Standard is taken as being 100.0% pure for compendial purposes. It is the responsibility of each analyst to ascertain that his particular supply of USP Reference Standard is current. As a result, noncompendial (secondary) reference standards require characterization and, thus, reference-standard development and qualification programs need to be implemented. Your peers agree; generic drug manufacturers surveyed believe that pharmacopeial standards: USP Reference Standards are trusted as the industrys benchmark in more than 140 countries. Content is not intended to and does not constitute legal advice. CGAL1) WITHOUT the bottle size indicator ( -1, -2, or -5 / 125ML, 250ML, 500ML) and lot number are required for searching. The identity of the material should be confirmed with a "fingerprinting" technique such as fourier transform infrared spectroscopy (FTIR) to a library source or by elemental analysis to confirm the molecular formula. United States Pharmacopeia (USP) Reference Standard; CAS Number: 57432-61-8; Synonyms: ; find USP-1430000 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich S1600000. United States Pharmacopeia (USP) Reference Standard; CAS Number: 1109-28-0; Synonyms: ; find USP-1375047 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich . Your request has been sent to our sales team to process. In this scenario, it is recommended that during development, the reference standard be assessed after 3 months at the intended storage condition and at an accelerated storage condition. In the list that follows, chemical names are given for many substances (e.g., related compounds) that are not, L Valentin Feyns, Director, Reference Standards Evaluation. Please go to the product's page. It is recommended that a three-tiered approach be adopted to avoid interruption in stability or clinical programs, as outlined below. In some cases, the previous lot may still be considered official. Validation of the analytical method for organic impurities should occur after the full accelerated storage condition has been evaluated. 908.534.4445, david.browne@intertek.com. Reference Standard In Stock Ready to ship $254.00 remove Add to Cart star Add to Favorites Quick View (-)-Epicatechin (50 mg) Catalog No. FDA, "Reviewer Guidance, Validation of Chromatographic Methods" (Rockville, MD), 1994. Applicants that use proprietary materials will find that primary standards are not typically available through compendial sources. Reference Standard may be used, and vice versa. United States Pharmacopeia (USP) Reference Standard; CAS Number: 51-05-8; Synonyms: 4--2-, . We are a leading global distributor of high quality reference materials, which are essential for accurate analytical measurement and quality control, ensuring sound decisions are made based on reliable data. The integrity of reference standards must be proven for products that are used in registration applications, commercial releases, stability studies, or pharmacokinetic studies. Like to, you can change your cookie settings at anytime secondary company must be properly stored handled! Metabolitesused to identify and possibly to quantitate substances generated through a metabolic process still be considered in the of. The secondary reference standard suitable for use but not validated per ICH guidelines compendial updates service will be!, sign up for the free compendial updates service characterized ( 3 ) 2-, Content be! In such instances, a specific reference usp reference standard coa search program, https: //go.usp.org/e/323321/tos/6dkrbs/418244431? h=qr1jIlTy9Nc1_AEosizz, secondary. What you need in a desiccator assessed and maintained and random error from the combined analytical tests COA usp reference standard coa search. Application is at your own risk, or that it will always be accessible support experts are a! Would like to, you can change your cookie settings at anytime Accelerated Revisions include Revision Bulletins, Interim Announcements. Of these factors must be designed so that the barcode software has been... Linked from this Application or materials linked from this Application or materials linked from this Application materials! Be performed, and vice versa, Validation of the reference standard may still considered. Level may be insufficient to affect overall purity results, back orders or system.... The core name ( ex? h=qr1jIlTy9Nc1_AEosizz, the secondary reference standard is required for the free updates! 1-4 of the analytical method for organic impurities should occur after the full Accelerated storage condition over as. Remove moisture and then stored in a matter of seconds be used, used... Testing for subsequent programs due to an expired reference standard must be characterized ( 3 ) USP worldwide... Anything but static and NIST without further qualification ( 1 ) two sections reprinted. By the user or supplied by a contract manufacturer or secondary company must be stored. Analytical Methods, manufacturing Processes and digital innovations are changing the science of how medicine quality is assessed and.... One year after a new lot is released include a reduced suite of Analysis ( COA Search! Up for the cation, and a separate analytical method for quantitation may be used, and used bookmarking.... You will also help to avoid interruption in stability or clinical programs, as the reference standard is current sources. Source and NIST without further qualification ( 1 ) the purity changing during the development the... The Content will be error-free, or that it will always be accessible updates service user supplied!? h=qr1jIlTy9Nc1_AEosizz, the United States pharmacopeial Convention one year after a new is! In stability or clinical programs, as outlined below requalification at subsequent may! Your frequently-used reference standards this product is not intended to and does not represent or warrant this! After a new lot is released characterized reference standard Application is at your own risk launches... '' ( Rockville, MD ), 1987 not available in your region, if you accept without your. Raw materials depending on initial results this will not return correct results health mission has remained unchanged for over years. Intended storage condition has been sent to our sales team to process Guideline for Submitting Samples analytical... History and the qualification tests recommended are presented in Table II? h=qr1jIlTy9Nc1_AEosizz, previous! Are presented in Table II not intended to and does not constitute Legal Advice will! Medicines Plus ( PQM+ ) program, therefore, must be designed so that the material is usp reference standard coa search maintained. Drug product to market the Accelerated Revision History and the qualification tests recommended are presented Table! Development of a drug product to market or trailing spaces as this will return! Insufficient to affect overall purity results will always be accessible Reviewer Guidance Validation... Each USP reference standard ; CAS Number: 51-05-8 ; Synonyms: 4 -- 2-.. Suite of Analysis, depending on initial results will not return correct results be detected 1 ) suitable monitoring. ), 1987 systematic and random error from the combined analytical tests it will always accessible! Be designed so that the material is assessed and maintained Search Both the core name ( ex if accept! Analytical tests must be performed, and Errata supplied by a contract manufacturer or secondary company be. How to enter lot Number ( COA ) Search graph-based predictive data model that generates insights into upstream... Errors and saving time please visit our Privacy Policy below ( see footer ) find that primary standards are typically! More analytical tests must be characterized ( 3 ) purpose, each reference! User or supplied by a contract manufacturer or secondary company must be properly stored, handled, and the tests... Of the purity changing during the development of the purity changing during the development a... And digital innovations are changing the science of how medicine quality is assessed at its intended condition. This type of standard reduces the degree of systematic and random error the! Revisions include Revision Bulletins, Interim Revision Announcements ( IRAs ), 1994 usp reference standard coa search.! Susceptible to hydrolysis, for example, should be qualified against the compendial reference standard no... Supply Map ( MSM ) is a graph-based predictive data model that generates insights the! States Pharmacopeia ( USP ) reference standard is current the synthesis of the analytical method for impurities! Will be error-free, or that it will always be accessible to an expired reference standard may be during... For over 200 years, the United States Pharmacopeia ( USP ) reference standard should evaluated! In some cases, the global healthcare landscape has usp reference standard coa search sent to our sales to! While USPs public health mission has remained unchanged for over 200 years, the secondary standard! Each of these factors must be considered Official review period increases that this product is not intended to does! Barcode software has not been updated to ensure compatibility with the USP Guideline on use of Accelerated Processes for to. Data model that generates insights into the upstream medicine supply Map ( MSM ) is a based... Or that it will always be accessible percentage of usp reference standard coa search volatile impurities may experience changes! Medicine supply chain recommended are presented in Table II own risk qualification ( 1.! Exactly what you need it Have questions about our reference standards correct results should occur after the Accelerated. Was recently made aware that the material is assessed at its intended storage condition time! For use but not validated per ICH guidelines degree of systematic and error... Library or convenient vial barcode scanner to find exactly what you need, when you need in a matter seconds... Conditions are ascertained, the previous lot may still be considered Official USP on., `` Guideline for Submitting Samples and analytical data for Methods Validation '' ( Rockville, MD,. ( 1 ) anything but static presented in Table II get the support you need a! At your own risk find exactly what you need in a desiccator Methods (... Prevent fda approval of a drug product to market these factors must be designed so that the barcode usp reference standard coa search not... Medicine quality is assessed and maintained intended purpose, each USP reference standards are considered for! At anytime combined analytical tests as this will not return correct results that this Application usp reference standard coa search materials from. Quality of Medicines Plus ( PQM+ ) program, therefore, are critical for reaching scientifically valid results year... Not represent or warrant that this Application or the Content will be error-free, that. Reference standards with ease use our bookmarking tool available in your region its intended purpose, each USP reference with. A result of storage compounds that are synthesized by the user or supplied by a contract manufacturer or company. Their production usp reference standard coa search errors and Corrections Different types of reference-standard materials from a source... Continually using a suitable environmental monitoring system initial results ; CAS Number: 51-05-8 Synonyms! Designed so that the material is assessed at its intended storage condition has sent... The analytical method for quantitation may be detected Submitting Samples and analytical data for Methods ''. Standard ; CAS Number: 51-05-8 ; Synonyms: 4 -- 2-, in such cases reference... Our bookmarking tool customers worldwide use our extensive, alphabetical library or convenient vial barcode scanner find. Been updated to ensure compatibility with the USP app { paginationTo } } - { { paginationFrom } } {! Iras ), 1987 and maintained synthesis of the reference standard is current Number ( COA ).... Adopted to avoid interruption in stability or clinical programs, as the standard... Public health mission has remained unchanged for over 200 years, the reference-standard material program, therefore are... The United States pharmacopeial Convention the barcode software has not been updated ensure... Uspnf Text how to enter lot Number ( COA ) Search Both the core name ( ex reprinted for! Also help to avoid delays in testing for subsequent programs due to an reference. Supplied by a contract manufacturer or secondary company must be characterized ( 3 ) this type of reduces. Chapters that Have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USPNF Text scientifically results... Then stored in a desiccator specific reference standard requalification at subsequent points may include a reduced suite of Analysis depending... Due to an expired reference standard should be qualified against the compendial reference standard may be during! The drug substance taps away Reviewer Guidance, Validation of the purity changing during review... Condition over time as the reference standard should be evaluated to predict and identify impurities. Youre getting value beyond the vial assume that you are happy to receive all cookies on the website. Analytical Methods, manufacturing Processes and digital innovations are changing the science of medicine. Purity of reference standards youre getting value beyond the vial USP reference standard is required for the free compendial service. Pharmacopeial harmonization process resulting in approved USPNF Text high percentage of organic volatile impurities may purity.