Explore our latest catalogue of research chemicals, analytical standards and the largest global collection of pathogenic virus strains. You can also save this item for later. Click here to subscribe to our newsletter, The Standard, to receive a monthly snapshot of new and updated RS's. USP Reference Standards are substances selected for their high purity, critical characteristics, and suitability for the intended purpose. Please check that the expiry date is fit for your purposes. Chemical purity must be determined for both groups; nuclidic reference standards, however, also need to be evaluated for radionuclidic and radiochemical purity. Properties pharmaceutical primary standard For instances in which a reference-standard material is not available from a commercial source, the material must be synthesized. HCl CAS Number: 122111-03-9 Molecular Weight: 299.66 MDL number: MFCD01735988 PubChem Substance ID: 329749929 INORGANIC VENTURES, TCT and PCRM are trademarks of I.V. Reference standards can be segregated into two groups: chemical and nuclidic (1). We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USPNF that link directly with our primary reference standards. reference standards 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. USP uses its Accelerated Revision processes to expedite revisions to the USPNF. By entering your email address, you confirm that you give your consent to LGC to share information in connection with the product(s) above and other similar products from time to time. S1600000. As an additional service, the USPC distributes several non-commercial reagents required in certain. The critical characteristics of each lot of specimen selected for the standard are usually determined independently in three or more laboratories. Antibiotic reference standards distributed by the USPC have been designated by the FDA as identical to FDA working standards under the FDA procedures. Labs, Inc. (d/b/a Inorganic Ventures) | 300 Technology Drive | Christiansburg, VA 24073. Quantitative analytical procedures for impurities' content or limit tests for the control of impurities must be validated and suitable for the detection and quantitation of impurities as directed by the International Conference on Harmonization (ICH) (6). 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). Once identity has been established and confirmed, the quality of the material must be ascertained. Lot Number. View Price and Availability. When you use these standards together, you know youre gaining value beyond the vial. HCl; find USP-1563502 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich Learn more about the harmonization process by visiting the HarmonizationPharmacopeial Discussion Group section of USP's website. 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. If there was 1% impurity based on area percent present, however, then there would be 2% of actual impurity that could affect overall purity. Based on the results, the material may require further purification by distillation or recrystallization. Regulatory agencies will accept reference-standard materials from a pharmacopeial source and NIST without further qualification (1). USPs Medicine Supply Map (MSM) is a graph-based predictive data model that generates insights into the upstream medicine supply chain. You will also receive alerts about product launches, back orders or system outages. These additional substances fall into three groups: (1) former USP and NF Reference Standards, not required in the current. 20, 2008. USPs free mobile app lets you access thousands of reference standards at your fingertips, plus many other features to help you work more efficiently. Then consider a reference standard with a purity of 99.9%, which has less need for additional characterization and potential degradation. Using machine learning and advanced analytics, MSM identifies, characterizes, and quantifies factors linked to supply chain disruptions for drug ingredients and finished drug products. For example, if the reference-standard material is a salt, then the cation response would not be equivalent to the reference standard. 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>. 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 The WHO program is concerned with reference materials for antibiotics, biologicals, and chemotherapeutic agents. Accepted: Sept. 22, 2008. 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 . In addition, useful stability information may be ascertained if the contingency conditions samples are tested as well as the intended storage condition. Results {{ paginationFrom }}-{{ paginationTo }} of {{ pagination.totalResults }}, {{stcIsOpen ? 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). You can sign up to be notified when anew never-before-released Reference Standard becomes available through the Reference Standards Release Notification Program . 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 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. Inorganic impurities. Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. USP Isoniazid United States Pharmacopeia (USP) Reference Standard Synonym (s): 4-Pyridinecarboxylic acid hydrazide, INH, Isonicotinic acid hydrazide, Isonicotinic hydrazide Empirical Formula (Hill Notation): C6H7N3O CAS Number: 54-85-3 Molecular Weight: 137.14 Beilstein: 119374 MDL number: MFCD00006426 PubChem Substance ID: 329750199 NACRES: NA.24 Promoting the Quality of Medicines Plus (PQM+) Program, https://store.usp.org/all-reference-standards/category/USP-1010, The United States Pharmacopeial Convention. Where it is directed that a Standard solution or a, Assay and test results are determined on the basis of comparisons of the specimen under test with a USP Reference Standard that has been freed from or corrected for volatile residues or water content as instructed on the label. Find your frequently-used reference standards with ease use our bookmarking tool. While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. USP Reference Standards are substances selected for their high purity, critical characteristics, and suitability for the intended purpose. How to . PHR2864. It should also be determined whether enantiomeric or polymorphic forms exist. Since some USP Reference Standards are standardized in terms of the corresponding International Standards, the relevant USP Units and the International Units of potency are generally identical. LGC will use your email address only for the purposes of providing the requested document. Looking for the most current stock COA? USP does not represent or warrant that this Application or the Content will be error-free, or that it will always be accessible. Lot Number. The integrity of reference standards must be proven for products that are used in registration applications, commercial releases, stability studies, or pharmacokinetic studies. USP does not warrant or represent that the Content available on or through this Application will be correct, accurate, timely, or otherwise reliable. The Terms and Conditions of Usage for the USP APP contain two sections regarding the content and usage of the USP APP. Elemental analysis, titration, GC, or LC can be used for purity determination. . Javascript is currently disabled in your browser. Heterogeneous substances, of natural origin, also are designated Reference Standards where needed. The approach to determining the relative-response factor for each impurity is a more accurate process, but potential pitfalls should be considered. (USP) Reference Standard. 0.1 M ZINC SULFATE VS - 2022-12-01. Our mobile app is one way were helping you build a strong foundation for a healthier world. Unless a Reference Standard label states a specific potency or content, the Reference Standard is taken as being 100.0% pure for compendial purposes. 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. A program to provide international biological standards and chemical reference substances is maintained by the World Health Organization, an agency of the United Nations. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (Geneva, Switzerland), Oct. 1994. ICH, Q3A(R2) Impurities in New Drug Substances (Geneva, Switzerland), Oct. 25, 2006. 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. Applicants that use proprietary materials will find that primary standards are not typically available through compendial sources. You will also receive alerts about product launches, back orders or system outages. For information about our data processing activities, please visit our Privacy Notice. 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. Where a USP Reference Standard is called for, the corresponding substance labeled as a U.S. Although there is no set guideline to characterize a reference-standard material, Figure 1 depicts a decision-tree approach involving broad range analytical techniques. This difference in labeling the Standards is in effect only temporarily, and eventually all vials will bear the same title. The USP APP utilizes a third-party Barcode App. Once the storage conditions are ascertained, the reference-standard material should be monitored continually using a suitable environmental monitoring system. Your use of Content on this Application or materials linked from this Application is at your own risk. Advances in analytical methods, manufacturing processes and digital innovations are changing the science of how medicine quality is assessed and maintained. It is advisable to store the material in at least two different locations in case there is a prolonged excursion from the storage condition. . If you accept without changing your settings, we assume that you are happy to receive all cookies on the LGC website. An insufficiently characterized reference standard may delay or prevent FDA approval of a drug product to market. For the best experience on our site, be sure to turn on Javascript in your browser. 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). (FIGURE 1 IS COURTESY OF THE AUTHOR.). Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USPNF. USP is addressing quality assurance, enhancing regulatory predictability, and helping manufacturers distribute quality medicines, dietary supplements and foods. USPC distributes both U.S. Reference Standards and USP Reference Standards for antibiotic substances. Potential degradation product also can occur as a result of storage. If not, click 'cancel'. Sign Up for Newsletters and Monthly Updates, Unavailable First Time Reference Standards, 0.1 N Potassium Permanganate VS - 2022-09-01, ACETATO DE MAFENIDA PARA SOLUCIN TPICA - 2023-01-01, cido Sulfrico 0,5 N en Alcohol SV - 2021-01-29, Actualizacin Sobre la Publicacin de los Avisos de Boletines de Revisin, ADVERTENCIAS Y REQUISITOS GENERALES - 2021-05-01, ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS - 2021-11-01, AMIODARONE HYDROCHLORIDE INJECTION - 2021-07-01, AMITRIPTYLINE HYDROCHLORIDE TABLETS - 2021-07-01, AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS - 2021-03-01, AMLODIPINO Y OLMESARTN MEDOXOMILO, TABLETAS - 2021-03-01, The United States Pharmacopeial Convention. NIST provides a certificate of analysis (CoA) that includes purity information and an expiration date. For example, if the intended storage condition is 28 C then the reference standard should also be stored at 20 C as a contingency. Register for free now to watch live or on-demand. Such a product can be monitored more effectively. 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. Usually these are the counterparts of international standards. Your punchout session will expire in1 min59 sec. Labs, Inc. All rights reserved. Nationally recognized standard institutions such as the National Institute for Standards and Testing (NIST). 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. Something went wrong, please try again later. 3. Reference standards that contain a high percentage of organic volatile impurities may experience purity changes over time as the solvents evaporate. Last Updated On: November 7, 2020. United States Pharmacopeia (USP) Reference Standard Synonym (s): Parathyroid Hormone Fragment 1-34 human, PTH 1-34, Parathormone (1-34) Empirical Formula (Hill Notation): C181H291N55O51S2 CAS Number: 52232-67-4 Molecular Weight: 4117.72 MDL number: MFCD00149013 NACRES: NA.24 Pricing and availability is not currently available. Lists of "New USP Reference Standards" and "Unavailable First-time Official USP Reference Standards" are provided below. 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. Inorganic impurities such as metals and noncombustible materials are typically evaluated using compendial procedures. Certificate of Analysis (COA) and Safety Data Sheet (SDS) Search, IF you do not see an SDS in the language you need, please. Click here to subscribe to our newsletter, The Standard, to receive a monthly snapshot of new and updated RS's. As a service, the USPC tests and distributes additional authenticated substances not currently required as USP or NF Reference Standards. Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. Due to the chemical nature of component(s) this product has a shorter shelf life. This level may be insufficient to affect overall purity results. Buy Sucrose USP compendial standard to determine strength, quality, purity and identity in prescribed USP-NF monograph tests and assays. Reference-standard materials that are synthesized by the user or supplied by a contract manufacturer or secondary company must be characterized (3). 1236620 CAS RN 490-46- Molecular Formula C15H14O6 Product Type Reference Standard In Stock Ready to ship $476.00 remove Add to Cart star Add to Favorites Quick View (-)-Epigallocatechin-3-O-gallate (20 mg) Please go to the product's page. Lot Number. Home; Search Results. Two columns appear in the Catalog to identify the current official lots. Please note, shipping and tax are calculated on the checkout page. If analysis shows an impurity at 0.05% and the relative response factor of the impurity is half of the standard (i.e., the amount of impurity present shows a 50% detector response compared with the equivalent amount of standard), then there could be 0.1% of actual impurity. FDA requires noncompendial reference standards to be "of the highest purity" and asks that reference standards validate analytical methods (1). 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. All rights reserved. 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. To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. Eur.) Home / Reference Standards / Small Molecules / Associated Drug Substance / Doxycycline Hyclate (200 mg) In Stock Ready to ship $265.00 Doxycycline Hyclate (200 mg) Catalog No: 1226003 CAS RN 24390-14-5 Molecular Formula: C12H24N2O8.1/2C2H6O.ClH.1/22H2O Product Type: Reference Standard Add to Cart star Add to Favorites Shipping Information As we work through these updates, you may experience some temporary discrepancies in information. 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. USP may make improvements and/or changes to its features, functionality or Content at any time. To fully understand the development of a reference-standard material program, the required method validation needs to be discussed. 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 Showing all {{product.analyteName.length}} analytes for this product. 6. 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. To provide users with the best experience possible, USP is currently updating its Refence Standards mobile application (USP APP). 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. The remaining 10% of impurities have to be identified and monitored through the life of the material. To consider the impact on the purity evaluation using area percent versus relative response factor, the following scenario may be considered. Heterogeneous substances, of natural origin, also are designated "Reference Standards" where needed. Metals impurityICP with MS detection or ICP with optical-emission spectroscopy detection, Noncombustible impuritiesresidue on ignition, Residual solventsGC with flame ionization detection, Structural confirmation: hydrogen and carbon13 NMR, LCMS, or FTIR. The author reviews the types of reference-standard materials used in drug-product manufacturing, discusses current regulatory requirements, and outlines a reference-standard qualification program. Neither Reference Standards nor Authentic Substances are intended for use as drugs or as medical devices. Wherever possible, therefore, compendial methods should be used to qualify reference standards. Please note that this is considered a controlled product in some countries, and needs to be treated in accordance with the relevant regulations. A new standard for Performance Verification Testing is now available for purchase! 2. How to enter Lot Number (COA) Search . If the reference-standard program requires tests that are not captured in compendial methods (as is the case with organic impurities), then analytical test procedures must be developed and qualified. 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. ICH also requires the reference material to be proven stable under the intended storage conditions for the intended use period (7). FDA, "Guideline for Submitting Samples and Analytical Data for Methods Validation" (Rockville, MD), 1987. 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. Download list of 23 new impurities & 7 new IP Reference standards The list of new 23 impurities standards includes: Citicoline Impurity B, The design of the long-term stress test depends on the intended storage condition. Please make sure there are no leading or trailing spaces as this will not return correct results. This requirement is meant to ensure that the product being evaluated is accurately tested to determine the amount of API present and to classify and identify related substances, process-related impurities, and degradation products. 'Show less' : 'Read more'}}, {{ product.brand.name ? 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. View current Notices of Stage4 Harmonization. To view all certificates of analysis immediately, please login to your accountor, Enter your email address and we'll email you the relevant CoA for lots: {{product.coaSelectedLotNumbers}}, We will be sending the CoA to your email address{{coaEmailPopupData.userEmail}}. In some cases, the previous lot may still be considered official. Impurities within acetone, a Class 3 solvent, for example, are permissible up to 5000 ppm or 0.5%, according to USP and ICH guidelines (5). Tier 2: At least two lots of reference-standard material should be placed in the qualification program three months apart. European Pharmacopoeia (Ph. Stage 6 adopted text is published so that USPNF users may become aware of its availability as a pharmacopeial standard and its targeted official date. Rather, the impurities must be isolated and identified so that an appropriate reference standard can be used, or a relative response factor determined. The distribution of controlled substances is subject to the regulations and licensing provisions of the Drug Enforcement Administration of the Department of Justice. 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. Different types of reference-standard materials and the qualification tests recommended are presented in Table II. Enter Lot Number to search for Certificate of Analysis (COA). Quantitation by area percent would not be appropriate in such cases. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. USP was recently made aware that the barcode software has not been updated to ensure compatibility with the USP APP. Product code: {{entry.product.displayPartCode ? 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. Harmonization Stage4 includes monographs or general chapters that have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USPNF text. 7. For the best experience on our site, be sure to turn on Javascript in your browser. 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. Need help finding your CoA or SDS? 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. Noncompendial. Qualification of a secondary source reference-standard material begins with obtaining a CoA, the synthesis pathway (if available), and a list of methods used in product manufacturing. However, the method can be assessed for parameters applicable to evaluating the reference material. This can be an expensive process and may delay the process of stability or clinical programs. 5. 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. The amount of acetone present may change during storage because of its volatility and therefore may alter the reference standard's purity. USP 30 NF 25 General Chapter <467>, "Residual Solvents.". This timeframe will also help to avoid delays in testing for subsequent programs due to an expired reference standard. Sucrose. 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 . Training resources and our customer support experts are just a few taps away. For the initial lot, an example requalification period may be 3, 6, and 12 months for the first year and annually thereafter. Initial characterization of the reference standard should include a full suite of analytical tests. If the amount of residual solvents present affects the purity, however, they should be evaluated at each requalification interval. FDA cites "failure to submit well characterized reference standards" as a "common problem that can delay successful validation" (3). 2023 MJH Life Sciences and Pharmaceutical Technology. Please login or register to add to your favourites, Or continue browsing without access to favourites or pricing, Please log in to view pricing and add to cart, Or continue browsing to see available rounds without pricing information, If you don't yet have an account, please create an account create an account.