Supelco. USPC distributes both U.S. Reference Standards and USP Reference Standards for antibiotic substances. Reference-standard materials that are synthesized by the user or supplied by a contract manufacturer or secondary company must be characterized (3). 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. '-' : entry.product.biosafetyLevel}} Tariff Code: {{entry.product.euTariffCode}}. Catalog Status RS Name Current Previous Lot CAS # NDC # Unit Co. Of Material UN # Net Unit Commodity Special Pkg. Enter Lot Number to search for Certificate of Analysis (COA). Usually these are the counterparts of international standards. Training resources and our customer support experts are just a few taps away. Then consider a reference standard with a purity of 99.9%, which has less need for additional characterization and potential degradation. View Price and Availability. As always, the most up to date information on reference standard products can be found online at our USP store. Please make sure there are no leading or trailing spaces as this will not return correct results. The USP APP utilizes a third-party Barcode App. It should also be determined whether enantiomeric or polymorphic forms exist. Generally, Reference Standards should be stored in their original stoppered containers away from heat and protected from light. Have questions about our reference standards? ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (Geneva, Switzerland), Oct. 1994. Reference-standard materials are often expensive to manufacture and are generally of limited supply. - United States Pharmacopeia (USP) Reference Standard; CAS Number: 427-49-6; Synonyms: 2--2-; find USP-1296042 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich JavaScript seems to be disabled in your browser. In addition, USP reference standards are considered suitable for use up to one year after a new lot is released. Pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). These also are provided under the supervision of the USP Reference Standards Committee. USP monographs include the name of the ingredient or preparation; the definition; labeling, packaging, storage requirements; and the specifications, which consist of a series of tests, procedures for the tests, and acceptance criteria. Inorganic impurities such as metals and noncombustible materials are typically evaluated using compendial procedures. Materials can be developed or purchased from chemical-supply companies for use as in-house secondary reference standards even when compendial reference standards are available. Where a USP Reference Standard is called for, the corresponding substance labeled as a U.S. Simply use our extensive, alphabetical library or convenient vial barcode scanner to find exactly what you need in a matter of seconds. 4. Initial characterization of the reference standard should include a full suite of analytical tests. In addition, this type of standard reduces the degree of systematic and random error from the combined analytical tests. Determination of organic impurities is the most challenging aspect of developing a suitable analytical method because these impurities are unique to the parent compound and because various degradation pathways can lead to various impurities. Try one of these options One of our custom-made smart solutions could be the answer. Feel confident that youve made the best decision. European Pharmacopoeia (Ph. Impurities classified as organic (process and drug related), inorganic, or residual solvents (4) can be introduced during the manufacturing process for the drug substance, drug product, or excipient and/or through storage of the material. Such a product can be monitored more effectively. While USP's public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. This difference in labeling the Standards is in effect only temporarily, and eventually all vials will bear the same title. Lot Number. United States Pharmacopeia (USP) Reference Standard Synonym (s): 5-Methoxy-2- [ [ (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, Antra, Losec Empirical Formula (Hill Notation): C17H19N3O3S CAS Number: 73590-58-6 Molecular Weight: 345.42 MDL number: MFCD00083192 PubChem Substance ID: 329750610 NACRES: NA.24 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. Usually these are the counterparts of international standards. For the best experience on our site, be sure to turn on Javascript in your browser. 2. For example, a reference standard used to determine potency requires full characterization and qualification. Search our catalogue using advanced query feature. Javascript is currently disabled in your browser. 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. USP offers over 7,000 USP Reference Standards, highly characterized physical specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents, and performance calibrators. 908.534.4445, david.browne@intertek.com. Quantitation by area percent would not be appropriate in such cases. Elemental analysis, titration, GC, or LC can be used for purity determination. For the best experience on our site, be sure to turn on Javascript in your browser. United States Pharmacopeia (USP) Reference Standard Synonym (s): 5-Methylisoxazole-4- (3-trifluoromethyl)carboxanilide, 5-Methyl-N- [3- (trifluoromethyl)phenyl]-4-isoxazolecarboxamide Empirical Formula (Hill Notation): C12H9F3N2O2 CAS Number: 61643-23- Molecular Weight: 270.21 Beilstein: 1083122 MDL: MFCD05741084 PubChem: 329750240 NACRES: Buy Sucrose USP compendial standard to determine strength, quality, purity and identity in prescribed USP-NF monograph tests and assays. The potential for residual solvents should be evaluated during development of the drug substance and can be estimated by reviewing the synthesis pathway. 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). Advances in analytical methods, manufacturing processes and digital innovations are changing the science of how medicine quality is assessed and maintained. Neither Reference Standards nor Authentic Substances are intended for use as drugs or as medical devices. NIST provides a certificate of analysis (CoA) that includes purity information and an expiration date. You will also receive alerts about product launches, back orders or system outages. USP uses its Accelerated Revision processes to expedite revisions to the USPNF. For APIs, the material may start out as a lot of drug substance with sufficient purity to be designated as the reference-standard material, or it may require further purification. 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. 2023 MJH Life Sciences and Pharmaceutical Technology. The WHO program is concerned with reference materials for antibiotics, biologicals, and chemotherapeutic agents. A reference standard used as a resolution component or identification requires less discerning analyses. After receipt of your order, if applicable, you may be contacted by your local sales office. USP Reference Standards Catalog. 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. 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. Properties All rights reserved. You can also save this item for later. However, the method can be assessed for parameters applicable to evaluating the reference material. With USP Reference Standards youre getting value beyond the vial. Content is not intended to and does not constitute legal advice. Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. 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. Please note, shipping and tax are calculated on the checkout page. Both the core name (ex. In all study scenarios, a protocol is required to outline the reference-standard material, lot, storage conditions, frequency of test, analytical procedures, acceptance criteria, and reporting criteria. This article addresss chemical reference standards only. 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. The answer is a compromise based on suitable parameters for the intended application. Organic impurities. New and Updated Interim Revision Announcements. Sucrose. Promoting the Quality of Medicines Plus (PQM+) Program, https://store.usp.org/all-reference-standards/category/USP-1010, The United States Pharmacopeial Convention. 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 Degradation products and compounds related to the product can be evaluated by the area percent or from the relative response of the standard being used. USP currently offers more than 3,500 Reference Standardshighly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagentsand performance calibrators. Please note that ATCC products may have restrictions, including but not limited to Biosafety Level (BSL) classifications and export/import permits. Known impurities or degradants will require custom synthesis. This level may be insufficient to affect overall purity results. 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. USP Reference Standards are established and released under the authority of the USPC Board of Trustees upon recommendation of the USP Reference Standards Committee, which passes on the selection and suitability of each lot. It is recommended that a three-tiered approach be adopted to avoid interruption in stability or clinical programs, as outlined below. USP was recently made aware that the barcode software has not been updated to ensure compatibility with the USP APP. Tier 3: At least two storage conditions should be chosen: the intended storage condition and an alternative storage condition as a contingency. In addition, as the reference standard ages, new unknown impurities may be detected. You will also receive alerts about product launches, back orders or system outages. How to . Access USP-NF Access USP-NF Spanish Edition, Learn more about Pharmaceutical Analytical Impurities, Pharmatech Associates, Inc., a USP company, Promoting the Quality of Medicines Plus (PQM+) Program, https://www.usp.org/sites/default/files/usp/video/products-and-solutions/products-and-solutions-video-banner.mp4, The United States Pharmacopeial Convention. USMCA KORUS Base Base # Lot (VUD) Price Origin Origin Weight Of Codes Restriction Type Eligible Eligible Control Control Measur (HS Codes)* Drug Drug % e 1000408 Active Abacavir Sulfate (200 R108M0 R028L0 (30 . The United States PharmacopeiaNational Formulary (USPNF) is continuously revised. To ascertain the degree to which an analytical method is deemed suitable for its intended use, the validation parameters set forth in ICH Q2(R1) Validation of Analytical Procedures (6) stipulates the following criteria: Not all parameters can be evaluated because a reference standard is required to perform quantitation. Heterogeneous substances, of natural origin, also are designated Reference Standards where needed. Reference standards that contain a high percentage of organic volatile impurities may experience purity changes over time as the solvents evaporate. 2023 MJH Life Sciences and Pharmaceutical Technology. As a rule, an International Standard for a material of natural origin is discontinued once the substance responsible for its characteristic activity has been isolated, identified, and prepared in such form that it can be completely characterized by chemical and physical means. The US Pharmacopeia (USP) defines reference-standard materials as "highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators" (2). 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. Certificate of Analysis (COA) and Safety Data Sheet (SDS) Search, IF you do not see an SDS in the language you need, please. 3. Should you need a product with a longer life, please contact your local sales office to place an order. Because USP regularly updates our standards, the app will notify you about any changes to your bookmarked reference standards so you can stay up-to-date. Accelerated Revisions include Revision Bulletins, Interim Revision Announcements (IRAs), and Errata. Antibiotic reference standards distributed by the USPC have been designated by the FDA as identical to FDA working standards under the FDA procedures. Your punchout session will expire in1 min59 sec. Select "Continue session" to extend your session. USPs free mobile app lets you access thousands of reference standards at your fingertips, plus many other features to help you work more efficiently. We found no results for "{0}". As a result, noncompendial (secondary) reference standards require characterization and, thus, reference-standard development and qualification programs need to be implemented. Sign Up for Newsletters and Monthly Updates, Unavailable First Time Reference Standards, the USP Guideline on Use of Accelerated Processes for Revisions to the, sign up for the free Compendial Updates service, View current Notices of Stage4 Harmonization, Learn more about the harmonization process by visiting the HarmonizationPharmacopeial Discussion Group section of USP's website, The United States Pharmacopeial Convention. Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. Properties grade pharmaceutical primary standard manufacturer/tradename USP application (s) FDA cites "failure to submit well characterized reference standards" as a "common problem that can delay successful validation" (3). USP does not represent or warrant that this Application or the Content will be error-free, or that it will always be accessible. Initial qualification and requalification. For users who use the USP APP without connecting to the internet, please note that this update will require access to the internet or phone provider once available. While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. If there was 1% impurity based on area percent present, however, then there would be 2% of actual impurity that could affect overall purity. Labs, Inc. All rights reserved. 20, 2008. If inorganic impurities are proven to be less than the reporting threshold at initial characterization, then further analysis is not required. USP 30NF 25 General Chapter <11>, "Reference Standards," p. 1. Properties pharmaceutical primary standard Download list of 23 new impurities & 7 new IP Reference standards The list of new 23 impurities standards includes: Citicoline Impurity B, An additional specific test procedure may be required if the USP procedure is not suitable for the reference standard being evaluated, or if the solvents used during synthesis are not included in USP <467>. ICH, Q3A(R2) Impurities in New Drug Substances (Geneva, Switzerland), Oct. 25, 2006. 5. This timeframe will also help to avoid delays in testing for subsequent programs due to an expired reference standard. Avoid humid storage areas in particular. Need help finding your CoA or SDS? Identification of impurities. The relative-response factor approach requires additional development because the component needs to be isolated and the relative response factor must be determined. I.V. INORGANIC VENTURES, TCT and PCRM are trademarks of I.V. 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. Home / Reference Standards / Biologics / Peptides / Vasopressin (1.71 mg) (Vasopressin, 8-L-arginine) (COLD SHIPMENT REQUIRED) In Stock Ready to ship $335.00 Vasopressin (1.71 mg) (Vasopressin, 8-L-arginine) (COLD SHIPMENT REQUIRED) Catalog No: 1711100 CAS RN 113-79-1 Molecular Formula: C46H65N15O12S2 Product Type: Reference Standard remove add 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 To consider the impact on the purity evaluation using area percent versus relative response factor, the following scenario may be considered. Distribution and control. This may allow for an extended life of the reference standard if it is proven to be unstable for a long period of time at its anticipated storage condition. Please refer to the full Terms and Conditions of usage for the USP APP here https://go.usp.org/e/323321/tos/6dkrbs/418244431?h=qr1jIlTy9Nc1_AEosizz. Additional testing may be required to identify and quantify known or potential impurities that may have been overlooked during the manufacturer's assessment of the material. 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. If you accept without changing your settings, we assume that you are happy to receive all cookies on the LGC website. If possible, it is recommended the reference standard be in a salt-free state to reduce the characterization tests required. These tests and procedures often require the use of official USP physical reference standards. It is the responsibility of each analyst to ascertain that his particular supply of USP Reference Standard is current. In such instances, the secondary reference standard should be qualified against the compendial reference standard. Accepted: Sept. 22, 2008. All available USP Reference Standards (RS) can be purchased in the USP iStore. 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. Once published in the print and online publications, Revision Bulletins and IRAs are official as of the date indicated on the website and are not subject to the general six-month delayed official date for the particular publication. Compendial. In such instances, a specific reference standard is required for the cation, and a separate analytical method for quantitation may be needed. United States Pharmacopeia (USP) Reference Standard; CAS Number: 67-73-2; Synonyms: ,6,9--11,16,17,21--1,4--3,20-,6,9--16-16,17-,6-,,; find USP-1275009 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich A program to provide international biological standards and chemical reference substances is maintained by the World Health Organization, an agency of the United Nations. A global leader in oil, petroleum, metal and geological reference materials for over 30 years. Actual and potential organic impurities that arise during synthesis, purification, and storage must be identified and quantitated. Scientists performing analytical testing use reference standards to determine quantitative (e.g., assay and impurity) as well as qualitative (e.g., identification tests) data, performance standards, and calibrators (e.g., melting point standards).