USP does not warrant or represent that the Content available on or through this Application will be correct, accurate, timely, or otherwise reliable. 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. Find your frequently-used reference standards with ease use our bookmarking tool. H2O CAS Number: 66985-17-9 Molecular Weight: 430.38 MDL: MFCD00792907 PubChem: 329750186 NACRES: NA.24 Pricing and availability is not currently available. 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. United States Pharmacopeia (USP) Reference Standard Synonym (s): 4-Hydroxy-3-methoxybenzaldehyde, Vanillic aldehyde Linear Formula: 4- (HO)C6H3-3- (OCH3)CHO CAS Number: 121-33-5 Molecular Weight: 152.15 Beilstein: 472792 MDL number: MFCD00006942 PubChem Substance ID: 329751485 Pricing and availability is not currently available. Actual and potential degradation products should be isolated and identified during development of the reference standard. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. The potential for residual solvents should be evaluated during development of the drug substance and can be estimated by reviewing the synthesis pathway. Enter Lot Number to search for Certificate of Analysis (COA). - 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 Were ready to help you. Only sufficient quantity for immediate use should be purchased, and long-term storage should be avoided. LGC will use your email address only for the purposes of providing the requested document. Distribution and control. entry.product.displayPartCode : entry.product.code}}, Biosafety Level Biosafety classification is based on U.S. Public Health Service Guidelines, it is the responsibility of the customer to ensure that they fully comply with all applicable biosafety and biomaterial regulations in their country. If not, click 'cancel'. 0.1 N Potassium Permanganate VS - 2022 . USP was recently made aware that the barcode software has not been updated to ensure compatibility with the USP APP. The reference-standard material program, therefore, must be designed so that the material is assessed at its intended storage condition over time. As an additional service, the USPC distributes several non-commercial reagents required in certain. 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. 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 For example, if the reference-standard material is a salt, then the cation response would not be equivalent to the 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. 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 However, if you would like to, you can change your cookie settings at anytime. While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. Download list of 23 new impurities & 7 new IP Reference standards The list of new 23 impurities standards includes: Citicoline Impurity B, Lot Number. Their purity requirements, hoewver, are generally not as stringent. Inorganic impurities. Register for free now to watch live or on-demand. How to . These also are provided under the supervision of the USP Reference Standards Committee. If so, it is identified in the second column. The quantity of organic impurities present can be determined with high-performance liquid chromatography (HPLC) and ultra-violet (UV) detection. An insufficiently characterized reference standard may delay or prevent FDA approval of a drug product to market. Reference-standard materials are often expensive to manufacture and are generally of limited supply. 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. The synthesis of the reference standard should be evaluated to predict and identify potential impurities from raw materials. Table I: Types of reference-standard material compared with recommended qualification. 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. Try one of these options One of our custom-made smart solutions could be the answer. In addition, useful stability information may be ascertained if the contingency conditions samples are tested as well as the intended storage condition. 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. Please make sure there are no leading or trailing spaces as this will not return correct results. Each of these factors must be considered in the development of a comprehensive reference-standard material program. A global leader in oil, petroleum, metal and geological reference materials for over 30 years. Newly Available USP Reference Standards (updated as of April 28, 2021) NIST provides a certificate of analysis (CoA) that includes purity information and an expiration date. Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USPNF. Javascript is currently disabled in your browser. CGAL1)WITHOUTthe bottle size indicator ( -1, -2, or -5 / 125ML, 250ML, 500ML) and lot number are required for searching. FDA cites "failure to submit well characterized reference standards" as a "common problem that can delay successful validation" (3). This raises the question, Which requirement should be met first: the qualification of the reference standard or its method validation? Reference standards that contain a high percentage of organic volatile impurities may experience purity changes over time as the solvents evaporate. If the amount of residual solvents present affects the purity, however, they should be evaluated at each requalification interval. ICH, Q3A(R2) Impurities in New Drug Substances (Geneva, Switzerland), Oct. 25, 2006. 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. Labs, Inc. (d/b/a Inorganic Ventures) | 300 Technology Drive | Christiansburg, VA 24073. 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: Please note that this is considered a controlled product in some countries, and needs to be treated in accordance with the relevant regulations. . Usually these are the counterparts of international standards. 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. Where special storage conditions are necessary, directions are given on the label. Sucrose. For example, a reference standard used to determine potency requires full characterization and qualification. Lot Number. You can sign up to be notified when anew never-before-released Reference Standard becomes available through the Reference Standards Release Notification Program . Figure 1: Decision-tree for reference-standard qualification. Reference-standard materials can be broadly categorized as such: The level of characterization depends on the intended use of the reference standard. Both the reference standards and drug substance may be synthesized initially using the same process. Submitted: Mar. Wherever possible, therefore, compendial methods should be used to qualify reference standards. Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. In this case, where the reference standard is the sample, the parameters validated are restricted. 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. The WHO program is concerned with reference materials for antibiotics, biologicals, and chemotherapeutic agents. This difference in labeling the Standards is in effect only temporarily, and eventually all vials will bear the same title. Get the support you need, when you need it Have questions about our reference standards? View Price and Availability. While USP's public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. 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. On the intended use of Accelerated Processes for Revisions to the USPNF,! 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