Have questions about our reference standards? If possible, it is recommended the reference standard be in a salt-free state to reduce the characterization tests required. Each of these factors must be considered in the development of a comprehensive reference-standard material program. This timeframe will also help to avoid delays in testing for subsequent programs due to an expired reference standard. New and Updated Interim Revision Announcements. Properties pharmaceutical primary standard +{{cartData.totalItems - displayNumberOfProducts}} additional products, Enzyme activators, inhibitors & substrates, Standards for environmental regulatory methods, Process materials, geological, cement and soils, {{facet.showAll ? 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. USP customers worldwide use our app to improve their production processreducing errors and saving time. Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USPNF. ICH also requires the reference material to be proven stable under the intended storage conditions for the intended use period (7). Identification of impurities. This level may be insufficient to affect overall purity results. The accuracy, completeness, adequacy or currency of the Content is not warranted or guaranteed. Please go to the product's page. 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. The reference-standard material program, therefore, must be designed so that the material is assessed at its intended storage condition over time. Although there is no set guideline to characterize a reference-standard material, Figure 1 depicts a decision-tree approach involving broad range analytical techniques. Inorganic impurities such as metals and noncombustible materials are typically evaluated using compendial procedures. 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. In such instances, the secondary reference standard should be qualified against the compendial reference standard. Home / Reference Standards / Small Molecules / Associated Drug Substance / Furosemide (200 mg) In Stock Ready to ship $265.00 Furosemide (200 mg) Catalog No: 1287008 CAS RN 54-31-9 Molecular Formula: C12-H11-Cl-N2-O5-S Product Type: Reference Standard remove add Add to Cart star Add to Favorites Shipping Information Current Lot Information 6. Accepted: Sept. 22, 2008. The remaining 10% of impurities have to be identified and monitored through the life of the material. Find your frequently-used reference standards with ease use our bookmarking tool. This difference in labeling the Standards is in effect only temporarily, and eventually all vials will bear the same title. ICH, Q1A(R2) Stability Testing of New Drug Substances and Products (Geneva, Switzerland), Feb. 6, 2003. Due to the chemical nature of component(s) this product has a shorter shelf life. To consider the impact on the purity evaluation using area percent versus relative response factor, the following scenario may be considered. 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. Tier 2: At least two lots of reference-standard material should be placed in the qualification program three months apart. It is the responsibility of each analyst to ascertain that his particular supply of USP Reference Standard is current. (USP) Reference Standard. Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. The WHO program is concerned with reference materials for antibiotics, biologicals, and chemotherapeutic agents. 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. The answer is a compromise based on suitable parameters for the intended application. 2023 MJH Life Sciences and Pharmaceutical Technology. Results {{ paginationFrom }}-{{ paginationTo }} of {{ pagination.totalResults }}, {{stcIsOpen ? - 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 For information about our data processing activities, please visit our Privacy Notice. 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 HCl; find USP-1563502 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich Elemental analysis, titration, GC, or LC can be used for purity determination. The USP APP is intended to be a convenient tool for users. . USP is addressing quality assurance, enhancing regulatory predictability, and helping manufacturers distribute quality medicines, dietary supplements and foods. . product.brand.name : product.manufacturer }}, {{priceList[index].price.formattedValue}} / {{product.uom}}, {{product.epDescriptions.join(', ') | truncate(44)}}, {{product.uspDescriptions.join(', ') | truncate(44)}}, {{product.productType.join(', ') | truncate(44)}}, {{ product.accreditations.length <= 2 ? The relative-response factor of these new impurities must be determined, and the method updated if the new unknown is significant enough to alter the purity. 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. ICH, Q3A(R2) Impurities in New Drug Substances (Geneva, Switzerland), Oct. 25, 2006. 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. The use of compendial reference standards is preferred for a reference-standard program. Barcode App Compatibility The quantity of organic impurities present can be determined with high-performance liquid chromatography (HPLC) and ultra-violet (UV) detection. The analytical procedures shown in Figure 1 are dependent on the evaluation of the development process. Impurities that are process-related should be kept to a minimum to avoid degradation and unwanted pharmacological effects. Were ready to help you. 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. Organic impurities. USP does not warrant or represent that the Content available on or through this Application will be correct, accurate, timely, or otherwise reliable. In this case, where the reference standard is the sample, the parameters validated are restricted. Catalog Status RS Name Current Previous Lot CAS # NDC # Unit Co. Of Material UN # Net Unit Commodity Special Pkg. These also are provided under the supervision of the USP Reference Standards Committee. Enter Lot Number to search for Certificate of Analysis (COA). USP Reference Standards are substances selected for their high purity, critical characteristics, and suitability for the intended purpose. USP does not represent or warrant that this Application or the Content will be error-free, or that it will always be accessible. The user (custom manufactures or synthesizes the reference standard), Specificityevaluation of interference from extraneous components, Rangethe interval between the lower and upper concentration amounts of analyte in the sample, Accuracya measure of the closeness of agreement between the value obtained and the theoretical, Precisiona measure of the closeness of agreement (degree of scatter) of the data values over a number of measurements (i.e., injection repeatability, analysis repeatability (multiple measurements, same analyst) and intermediate precision (multiple measurements, different days, different analysts), reproducibility (precision between different labs), Detection limitthe lowest level the analyte can be detected, Quantitation limitthe lowest level the analyte can be quantitated, Robustnesseffects of small changes in method parameters. To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. Not all standards are created equal. Table I presents recommended qualification parameters compared with reference-standard material type. Another reason to limit impurities is demonstrated in the following scenario. View Price and Availability. Once the storage conditions are ascertained, the reference-standard material should be monitored continually using a suitable environmental monitoring system. Tier 1: The reference-standard material qualification program should be started at least one month before the stability or clinical program begins to allow for requalification and assignment of a new expiration date. FDA requires reference standards to be of the "highest purity that can be obtained through reasonable effort" and to be "thoroughly characterized to assure the identity, strength, and quality" (3). 'Show less' : 'Read more'}}, {{ product.brand.name ? Where a USP Reference Standard is called for, the corresponding substance labeled as a U.S. Lot Number. Using machine learning and advanced analytics, MSM identifies, characterizes, and quantifies factors linked to supply chain disruptions for drug ingredients and finished drug products. 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. Harmonization Stage4 includes monographs or general chapters that have completed stages 1-4 of the pharmacopeial harmonization process resulting in approved USPNF text. I.V. Compendial. Reference Standard In Stock Ready to ship $254.00 remove Add to Cart star Add to Favorites Quick View (-)-Epicatechin (50 mg) Catalog No. The alphabetical list that follows constitutes an index of all revisions to this chapter. To search for your product specific CoA, you will need the Catalog Number and Lot Number. In addition, USP reference standards are considered suitable for use up to one year after a new lot is released. View Price and Availability. Last Updated On: November 7, 2020. If inorganic impurities are proven to be less than the reporting threshold at initial characterization, then further analysis is not required. While USP's public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. European Pharmacopoeia (EP) Reference Standard . The USP APP utilizes a third-party Barcode App. Reference Standards currently labeled as NF Reference Standards will eventually all be designated and labeled as USP Reference Standards pursuant to the consolidation of USP and NF within the USPC as of January 2, 1975. Reference standards can be segregated into two groups: chemical and nuclidic (1). Feel confident that youve made the best decision. A new standard for Performance Verification Testing is now available for purchase! Short-term (forced degradation) and long-term (evaluation under accelerated conditions) stress testing, therefore, should be evaluated during development. Labs, Inc. (d/b/a Inorganic Ventures) | 300 Technology Drive | Christiansburg, VA 24073. Please note that this is considered a controlled product in some countries, and needs to be treated in accordance with the relevant regulations. Reference-standard materials that are synthesized by the user or supplied by a contract manufacturer or secondary company must be characterized (3). In addition, this type of standard reduces the degree of systematic and random error from the combined analytical tests. 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. United States Pharmacopeia (USP) Reference Standard; CAS Number: 51-05-8; Synonyms: 4--2-, . However, the method can be assessed for parameters applicable to evaluating the reference material. Should you need a product with a longer life, please contact your local sales office to place an order. Your use of Content on this Application or materials linked from this Application is at your own risk. Validation of the analytical method for organic impurities should occur after the full accelerated storage condition has been evaluated. Their purity requirements, hoewver, are generally not as stringent. 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 Table II: Types of reference-standard material compared with recommended test. Please note that ATCC products may have restrictions, including but not limited to Biosafety Level (BSL) classifications and export/import permits. Appearance confirmationvisual inspection. 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. Reference Standard may be used, and vice versa. The US Food and Drug Administration defines a reference-standard material as a "highly purified compound that is well characterized" (1). How to . United States Pharmacopeia (USP) Reference Standard Synonym (s): ddI, ddIno Empirical Formula (Hill Notation): C10H12N4O3 CAS Number: 69655-05-6 Molecular Weight: 236.23 Beilstein: 3619529 MDL: MFCD00077728 PubChem: 329749572 NACRES: NA.24 Pricing and availability is not currently available. The distribution of controlled substances is subject to the regulations and licensing provisions of the Drug Enforcement Administration of the Department of Justice. United States Pharmacopeia (USP) Reference Standard; CAS Number: 54-71-7; Synonyms: (3S,4R)-4,5--3--4-(1--1H--5-)-2(3H)- ; find USP-1538902 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich Consider a reference standard that is 90% pure. Residual solvents. Explore our latest catalogue of research chemicals, analytical standards and the largest global collection of pathogenic virus strains. 1. Not Legal Advice 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. Actual and potential degradation products should be isolated and identified during development of the reference standard. Your request has been sent to our sales team to process. 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. 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. Content is not intended to and does not constitute legal advice. We use cookies to ensure that we give you the best experience of our website. Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. How to enter Lot . Simply use our extensive, alphabetical library or convenient vial barcode scanner to find exactly what you need in a matter of seconds. Then consider a reference standard with a purity of 99.9%, which has less need for additional characterization and potential degradation. PHR2864. 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. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USPNF that link directly with our primary reference standards. As we work through these updates, you may experience some temporary discrepancies in information. 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. Initial characterization of the reference standard should include a full suite of analytical tests. Applicants that use proprietary materials will find that primary standards are not typically available through compendial sources. LGC will process your personal data in accordance with all applicable data protection rules and regulations. 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. The design of the long-term stress test depends on the intended storage condition. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (Geneva, Switzerland), Oct. 1994. FDA, "Guideline for Submitting Samples and Analytical Data for Methods Validation" (Rockville, MD), 1987. 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. Instead, the AVRs are visual images used by analysts to compare certain test articles to ensure that they meet compendial requirements and are incorporated by reference into the monograph. 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). The suitability of a USP Reference Standard for noncompendial application is left up to the user. Meanwhile, where a USP Reference Standard is called for, the corresponding substance labeled as an NF Reference Standard may be used. Heterogeneous substances, of natural origin, also are designated Reference Standards where needed. To search for the SDS, you will just need the Product Name. USP 30NF 25 General Chapter <11>, "Reference Standards," p. 1. Enter Lot Number to search for Certificate of Analysis (COA). An insufficiently characterized reference standard may delay or prevent FDA approval of a drug product to market. Nationally recognized standard institutions such as the National Institute for Standards and Testing (NIST). Tier 3: At least two storage conditions should be chosen: the intended storage condition and an alternative storage condition as a contingency. Applying the molecular weight to the correction will not account for residual salt that may be produced during synthesis. No. 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. 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. Both the reference standards and drug substance may be synthesized initially using the same process. Table I: Types of reference-standard material compared with recommended qualification. 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Process-Related should be qualified against the compendial reference standard should be kept a. Lot Number to search for Certificate of Analysis ( COA ) list that follows constitutes an index of all to... Explore our latest catalogue of research chemicals, analytical standards and the largest global collection of pathogenic virus strains a... Rockville, MD ), Oct. 25, 2006 Revisions to the full Accelerated storage condition over time with primary! At any time evaluation of the long-term stress test depends on the evaluation of the of...