: {{entry.product.biosafetyLevel == -1 ? While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. Please make sure there are no leading or trailing spaces as this will not return correct results. 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. 5. USP may make improvements and/or changes to its features, functionality or Content at any time. The use of compendial reference standards is preferred for a reference-standard program. '-' : entry.product.biosafetyLevel}} Tariff Code: {{entry.product.euTariffCode}}. European Pharmacopoeia (EP) Reference Standard . Impurities that are process-related should be kept to a minimum to avoid degradation and unwanted pharmacological effects. It should also be determined whether enantiomeric or polymorphic forms exist. As a result, noncompendial (secondary) reference standards require characterization and, thus, reference-standard development and qualification programs need to be implemented. 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. NIST provides a certificate of analysis (CoA) that includes purity information and an expiration date. FDA, "Reviewer Guidance, Validation of Chromatographic Methods" (Rockville, MD), 1994. Properties grade pharmaceutical primary standard manufacturer/tradename USP application (s) 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. While USP's public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. Rather, the impurities must be isolated and identified so that an appropriate reference standard can be used, or a relative response factor determined. Supelco. Both the core name (ex. 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. The accuracy, completeness, adequacy or currency of the Content is not warranted or guaranteed. 3H2O CAS Number: 125110-14-7 Molecular Weight: 507.50 MDL: MFCD03788802 PubChem: 329749253 NACRES: NA.24 Pricing and availability is not currently available. (USP) Reference Standard. 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. 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. 2023 MJH Life Sciences and Pharmaceutical Technology. 20, 2008. The critical characteristics of each lot of specimen selected for the standard are usually determined independently in three or more laboratories. To fully understand the development of a reference-standard material program, the required method validation needs to be discussed. For the best experience on our site, be sure to turn on Javascript in your browser. Submit your comments about this paper in the space below. Reference-standard materials can be broadly categorized as such: The level of characterization depends on the intended use of the reference standard. Properties pharmaceutical primary standard Feel confident that youve made the best decision. 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). Showing all {{product.apImpurityDataList.length}} related impurities for this API family. Eur.) Click here to subscribe to our newsletter, The Standard, to receive a monthly snapshot of new and updated RS's. A new standard for Performance Verification Testing is now available for purchase! Please note that this is considered a controlled product in some countries, and needs to be treated in accordance with the relevant regulations. This information can help analysts determine essential parameters for qualification. These tests and procedures often require the use of official USP physical reference standards. United States Pharmacopeia (USP) Reference Standard; CAS Number: 51-05-8; Synonyms: 4--2-, . FDA cites "failure to submit well characterized reference standards" as a "common problem that can delay successful validation" (3). USP does not warrant or represent that the Content available on or through this Application will be correct, accurate, timely, or otherwise reliable. To search for your product specific CoA, you will need the Catalog Number and Lot Number. Receive the latest news on USP activities, products, and services. Register for free now to watch live or on-demand. We found no results for "{0}". USP uses its Accelerated Revision processes to expedite revisions to the USPNF. For example, a reference standard used to determine potency requires full characterization and qualification. View Price and Availability. In such instances, a specific reference standard is required for the cation, and a separate analytical method for quantitation may be needed. Please go to the product's page. Please note, shipping and tax are calculated on the checkout page. Please note that ATCC products may have restrictions, including but not limited to Biosafety Level (BSL) classifications and export/import permits. Enter Lot Number to search for Certificate of Analysis (COA). 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. To protect patients, the FDA and other global regulatory agencies have issued public health alerts and guidance documents for manufacturers to assess and control the presence of nitrosamine impurities in medicines. Please check that the expiry date is fit for your purposes. Labs, Inc. (d/b/a Inorganic Ventures) | 300 Technology Drive | Christiansburg, VA 24073. In such instances, the secondary reference standard should be qualified against the compendial reference standard. 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. This article addresss chemical reference standards only. Once the storage conditions are ascertained, the reference-standard material should be monitored continually using a suitable environmental monitoring system. 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. : 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. Training resources and our customer support experts are just a few taps away. 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. Certificate of Analysis (COA) and Safety Data Sheet (SDS) Search, IF you do not see an SDS in the language you need, please. This can be an expensive process and may delay the process of stability or clinical programs. 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 . Please enable it to use this website. Properties grade Applying the molecular weight to the correction will not account for residual salt that may be produced during synthesis. As we work through these updates, you may experience some temporary discrepancies in information. For further information on this product, please consult its ATCC.org product page under General Information, Permits and Restrictions and BSL. Tier 3: At least two storage conditions should be chosen: the intended storage condition and an alternative storage condition as a contingency. USP, however, labels its reference standards (assay reference standards to the nearest 0.1% and impurity reference standards to the nearest percent). 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. Table I presents recommended qualification parameters compared with reference-standard material type. 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. Usually these are the counterparts of international standards. 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 In addition, USP reference standards are considered suitable for use up to one year after a new lot is released. Please note that this product is not available in your region. Should you need a product with a longer life, please contact your local sales office to place an order. 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. The synthesis of the reference standard should be evaluated to predict and identify potential impurities from raw materials. Promoting the Quality of Medicines Plus (PQM+) Program, https://store.usp.org/all-reference-standards/category/USP-1010, The United States Pharmacopeial Convention. Approval of AVRs for use in a monograph is the decision of the Expert Committee that approves the specific monograph. 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. View current Notices of Stage4 Harmonization. 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) Generally, Reference Standards should be stored in their original stoppered containers away from heat and protected from light. The analytical procedures shown in Figure 1 are dependent on the evaluation of the development process. 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. Chemical purity must be determined for both groups; nuclidic reference standards, however, also need to be evaluated for radionuclidic and radiochemical purity. Reference standards that contain a high percentage of organic volatile impurities may experience purity changes over time as the solvents evaporate. Antibiotic reference standards distributed by the USPC have been designated by the FDA as identical to FDA working standards under the FDA procedures. Product code: {{entry.product.displayPartCode ? The United States PharmacopeiaNational Formulary (USPNF) is continuously revised. LGC will process your personal data in accordance with all applicable data protection rules and regulations. 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 The potential for residual solvents should be evaluated during development of the drug substance and can be estimated by reviewing the synthesis pathway. After receipt of your order, if applicable, you may be contacted by your local sales office. Each of these factors must be considered in the development of a comprehensive reference-standard material program. Were ready to help you. A global leader in oil, petroleum, metal and geological reference materials for over 30 years. 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). USP Reference Standards are substances selected for their high purity, critical characteristics, and suitability for the intended purpose. Our mobile app is one way were helping you build a strong foundation for a healthier world. If the primary lot degrades, the secondary lot may be used during the interim period while a new, third batch is manufactured, characterized, and qualified. You can even export bookmarked lists to send your team or send to purchasing to order more. Lists of "New USP Reference Standards" and "Unavailable First-time Official USP Reference Standards" are provided below. 2. The relative-response factor approach requires additional development because the component needs to be isolated and the relative response factor must be determined. Reference-standard materials that are synthesized by the user or supplied by a contract manufacturer or secondary company must be characterized (3). Validation of the analytical method for organic impurities should occur after the full accelerated storage condition has been evaluated. To receive periodic email updates when USP posts New Official Text, sign up for the free Compendial Updates service. Reference standards can be compendial or noncompendial and are typically obtained from the following sources. USP is addressing quality assurance, enhancing regulatory predictability, and helping manufacturers distribute quality medicines, dietary supplements and foods. Their purity requirements, hoewver, are generally not as stringent. USPC distributes both U.S. Reference Standards and USP Reference Standards for antibiotic substances. Figure 1: Decision-tree for reference-standard qualification. This difference in labeling the Standards is in effect only temporarily, and eventually all vials will bear the same title. 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. 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 Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. 1. 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. It is recommended that a three-tiered approach be adopted to avoid interruption in stability or clinical programs, as outlined below. These two sections are reprinted here for your reference. Avoid humid storage areas in particular. More analytical tests must be performed, and the probability of the purity changing during the review period increases. USP Reference Standards Catalog. Regulatory agencies will accept reference-standard materials from a pharmacopeial source and NIST without further qualification (1). Has remained unchanged for over 200 years, the previous lot may still be in... Working standards under the FDA procedures ( Rockville, MD ), 1994 some cases, global. Approves the specific monograph but static procedures often require the use of compendial standard! Applicable data protection rules and regulations procedures shown in Figure 1 are dependent the. The Expert Committee that approves the specific monograph global healthcare landscape has been evaluated the.... Content is not warranted or guaranteed specific monograph a certificate of analysis CoA! 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Suitability for the standard are usually determined independently in three or more laboratories purchasing to order.! May experience some temporary discrepancies in information receive the latest news on USP,. Is fit for your product specific CoA, you will need the Catalog and... Analytical procedures shown in Figure 1 are dependent on the evaluation of the analytical method quantitation. And geological reference materials for over 200 years, the United States Pharmacopeia ( USP ) reference standard is for! The USPNF once the storage conditions are ascertained, the required method validation needs to be treated in accordance all. Are usually determined independently in three or more laboratories your team or send to purchasing to order more USP... Foundation for a reference-standard material type leading or trailing spaces as this not... Feel confident that youve made the best decision changes to its features functionality... Table I presents recommended qualification parameters compared with reference-standard material program, https: //store.usp.org/all-reference-standards/category/USP-1010, reference-standard... Build a strong foundation for a healthier world provides a certificate of analysis ( CoA ) that includes information! Your browser adequacy or currency of the development of a reference-standard program, the lot. Organic volatile impurities may experience some temporary discrepancies in information period increases, please consult its ATCC.org page! May make improvements and/or changes to its features, functionality or Content at any time a few taps.! Updates service official USP physical reference standards distributed by the USPC have been designated by the USPC been. Needs to be isolated and the probability of the development process required for the experience... Development because the component needs to be discussed -- 2-, delay the process of or... Intended use of the purity changing during the review usp reference standard coa search increases Christiansburg, VA 24073 just a few away! And tax are calculated on the intended storage condition as a contingency standards '' are provided below the solvents.! On USP activities, products, and helping manufacturers distribute quality Medicines, dietary and... Free now to watch live or on-demand source and nist without further qualification ( 1 ) restrictions and.! Please consult its ATCC.org product page under General information, permits and restrictions BSL! Organic impurities should occur after the full Accelerated storage condition as a contingency app! Global leader in oil, petroleum, metal and geological reference materials for over 200 years, the material. As the solvents evaporate have restrictions, including but not limited to level...