Eur.) 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. The analytical procedures shown in Figure 1 are dependent on the evaluation of the development process. Pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP). 'Show less' : 'Read more'}}, {{ product.brand.name ? Please enable it to use this website. 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. FDA requires noncompendial reference standards to be "of the highest purity" and asks that reference standards validate analytical methods (1). Javascript is currently disabled in your browser. Requalification at subsequent points may include a reduced suite of analysis, depending on initial results. Results {{ paginationFrom }}-{{ paginationTo }} of {{ pagination.totalResults }}, {{stcIsOpen ? USPs free mobile app lets you access thousands of reference standards at your fingertips, plus many other features to help you work more efficiently. For information relating to LGCs data processing activities, please visit our Privacy Policy below (see footer). FDA, "Reviewer Guidance, Validation of Chromatographic Methods" (Rockville, MD), 1994. Labs, Inc. All rights reserved. Learn more by visiting the Accelerated Revision History and the USP Guideline on Use of Accelerated Processes for Revisions to the USPNF. 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. If the initial lot is proven to be stable for at least one year, then subsequent lots will require annual requalification only. Not all standards are created equal. Properties pharmaceutical primary standard USP Reference Standards are substances selected for their high purity, critical characteristics, and suitability for the intended purpose. The material should be stored in a secure environment with controlled access and distribution. 2023 MJH Life Sciences and Pharmaceutical Technology. (USP) Reference Standard. For further information on this product, please consult its ATCC.org product page under General Information, Permits and Restrictions and BSL. 1. 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). Updates are being prepared and will be deployed shortly. These two sections are reprinted here for your reference. We establish primary standards for helping to ensure quality in pharmaceutical development and manufacturing. You dont have to waste time flipping through countless pages of standards. 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. LGC will process your personal data in accordance with all applicable data protection rules and regulations. The USP APP is intended to be a convenient tool for users. FDA, "Guideline for Submitting Samples and Analytical Data for Methods Validation" (Rockville, MD), 1987. 6. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USPNF that link directly with our primary reference standards. It is the responsibility of each analyst to ascertain that his particular supply of USP Reference Standard is current. 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 Public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. Promoting the Quality of Medicines Plus (PQM+) Program, https://store.usp.org/all-reference-standards/category/USP-1010, The United States Pharmacopeial Convention. With USP Reference Standards youre getting value beyond the vial. 2023 MJH Life Sciences and Pharmaceutical Technology. In this case, where the reference standard is the sample, the parameters validated are restricted. Figure 1: Decision-tree for reference-standard qualification. If so, it is identified in the second column. Advances in analytical methods, manufacturing processes and digital innovations are changing the science of how medicine quality is assessed and maintained. Please make sure there are no leading or trailing spaces as this will not return correct results. The reference-standard material program, therefore, must be designed so that the material is assessed at its intended storage condition over time. To search for the SDS, you will just need the Product Name. Although there is no set guideline to characterize a reference-standard material, Figure 1 depicts a decision-tree approach involving broad range analytical techniques. Impurities should be controlled throughout the manufacturing process. Contact us atinfo@inorganicventures.com. NIST provides a certificate of analysis (CoA) that includes purity information and an expiration date. Submit your comments about this paper in the space below. 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). Different types of reference-standard materials and the qualification tests recommended are presented in Table II. Search our catalogue using advanced query feature. Certificate of Analysis (COA) and Safety Data Sheet (SDS) Search, IF you do not see an SDS in the language you need, please. Metabolitesused to identify and possibly to quantitate substances generated through a metabolic process. 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. . Quantitation by area percent would not be appropriate in such cases. Table I presents recommended qualification parameters compared with reference-standard material type. Get the support you need, when you need it Have questions about our reference standards? Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help 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 ? 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}}. Where special drying requirements for Reference Standards are found in specific sections of, Revisions, additions, and deletions of individual USP Reference Standards are listed cumulatively in each Supplement to, Revisions of this chapter are implemented continuously via the. The amount of acetone present may change during storage because of its volatility and therefore may alter the reference standard's purity. . ICH, Q3A(R2) Impurities in New Drug Substances (Geneva, Switzerland), Oct. 25, 2006. Table I: Types of reference-standard material compared with recommended qualification. On the 23rd February, AXIO, Dr Ehrenstorfer and Digamma Consultancy will come together to answer your questions on cannabis testing. All available USP Reference Standards (RS) can be purchased in the USP iStore. However, the method can be assessed for parameters applicable to evaluating the reference material. Once the storage conditions are ascertained, the reference-standard material should be monitored continually using a suitable environmental monitoring system. Simply use our extensive, alphabetical library or convenient vial barcode scanner to find exactly what you need in a matter of seconds. If inorganic impurities are proven to be less than the reporting threshold at initial characterization, then further analysis is not required. Known impurities or degradants will require custom synthesis. 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. 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. Minimal required tests for initial characterization are typically performed using the following tests: Other tests may include chiral evaluation (HPLC with UV detection), melting point, differential scan calorimetry, and polymorph evaluation by X-ray powder diffraction. If not, click 'cancel'. USPs Medicine Supply Map (MSM) is a graph-based predictive data model that generates insights into the upstream medicine supply chain. 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. David Browne is manager of stability and pharmaceutical testing at Intertek Pharmaceutical Services, d/b/a QTI, 291 Route 22 East, Whitehouse, NJ 08888, tel. A program to provide international biological standards and chemical reference substances is maintained by the World Health Organization, an agency of the United Nations. The WHO program is concerned with reference materials for antibiotics, biologicals, and chemotherapeutic agents. In addition, USP reference standards are considered suitable for use up to one year after a new lot is released. 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. PHR2864. For the best experience on our site, be sure to turn on Javascript in your browser. System suitability testingevaluation of the suitability of the equipment. Register for free now to watch live or on-demand. 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. In such cases, measurements are made on preparations of both the test specimen and the Reference Standard. Consider a reference standard that is 90% pure. Neither Reference Standards nor Authentic Substances are intended for use as drugs or as medical devices. 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. Errors and Corrections The suitability of a USP Reference Standard for noncompendial application is left up to the user. A new standard for Performance Verification Testing is now available for purchase! 908.534.4445, david.browne@intertek.com. : {{entry.product.biosafetyLevel == -1 ? 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. Training resources and our customer support experts are just a few taps away. Click here to subscribe to our newsletter, The Standard, to receive a monthly snapshot of new and updated RS's. No. 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 may make improvements and/or changes to its features, functionality or Content at any time. The US Food and Drug Administration defines a reference-standard material as a "highly purified compound that is well characterized" (1). Reference Standard In Stock Ready to ship $254.00 remove Add to Cart star Add to Favorites Quick View (-)-Epicatechin (50 mg) Catalog No. All rights reserved. For example, if the intended storage condition is 28 C then the reference standard should also be stored at 20 C as a contingency. For example, a reference standard used to determine potency requires full characterization and qualification. Using machine learning and advanced analytics, MSM identifies, characterizes, and quantifies factors linked to supply chain disruptions for drug ingredients and finished drug products. Properties pharmaceutical primary standard Learn about USPs portfolio of solutions to help address quality assurance, enhance regulatory predictability, and help manufacturers distribute quality medicines, dietary supplements and foods. Select "Continue session" to extend your session. This information can help analysts determine essential parameters for qualification. (FIGURE 1 IS COURTESY OF THE AUTHOR.). To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. 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. Table II: Types of reference-standard material compared with recommended test. I.V. This level may be insufficient to affect overall purity results. Compounds that are susceptible to hydrolysis, for example, should be thoroughly dried to remove moisture and then stored in a desiccator. H2O CAS Number: 66985-17-9 Molecular Weight: 430.38 MDL: MFCD00792907 PubChem: 329750186 NACRES: NA.24 Pricing and availability is not currently available. Unavailable First Time Reference Standards; Breadcrumb. Supelco. Noncompendial. 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. Enter Lot Number to search for Certificate of Analysis (COA). Such a product can be monitored more effectively. If possible, it is recommended the reference standard be in a salt-free state to reduce the characterization tests required. 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. Your punchout session will expire in1 min59 sec. Rather, the impurities must be isolated and identified so that an appropriate reference standard can be used, or a relative response factor determined. European Pharmacopoeia (Ph. 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. In addition, as the reference standard ages, new unknown impurities may be detected. A reference standard used as a resolution component or identification requires less discerning analyses. Two columns appear in the Catalog to identify the current official lots. 0.1 M ZINC SULFATE VS - 2022-12-01. 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. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results. If you accept without changing your settings, we assume that you are happy to receive all cookies on the LGC website. The alphabetical list that follows constitutes an index of all revisions to this chapter. 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 USP General Chapter <467> Residual Solvents details a generic procedure for this evaluation. In addition, useful stability information may be ascertained if the contingency conditions samples are tested as well as the intended storage condition. Our mobile app is one way were helping you build a strong foundation for a healthier world. In such instances, a specific reference standard is required for the cation, and a separate analytical method for quantitation may be needed. 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. Looking for the most current stock COA? How to . In some cases, the previous lot may still be considered official. Newly Available USP Reference Standards (updated as of April 28, 2021) 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 potential for residual solvents should be evaluated during development of the drug substance and can be estimated by reviewing the synthesis pathway. How to enter Lot . USP was recently made aware that the barcode software has not been updated to ensure compatibility with the USP APP. It is advisable to store the material in at least two different locations in case there is a prolonged excursion from the storage condition. The USP APP utilizes a third-party Barcode App. Download list of 23 new impurities & 7 new IP Reference standards The list of new 23 impurities standards includes: Citicoline Impurity B, 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. Lists of "New USP Reference Standards" and "Unavailable First-time Official USP Reference Standards" are provided below. Initial qualification and requalification. Heterogeneous substances, of natural origin, also are designated Reference Standards where needed. Another reason to limit impurities is demonstrated in the following scenario. Tier 3: At least two storage conditions should be chosen: the intended storage condition and an alternative storage condition as a contingency. In addition, this type of standard reduces the degree of systematic and random error from the combined analytical tests. These tests and procedures often require the use of official USP physical reference standards. Product code: {{entry.product.displayPartCode ? The remaining 10% of impurities have to be identified and monitored through the life of the material. Many Pharmacopeial tests and assays are based on comparison of a test specimen with a USP Reference Standard. Try one of these options One of our custom-made smart solutions could be the answer. 3H2O CAS Number: 125110-14-7 Molecular Weight: 507.50 MDL: MFCD03788802 PubChem: 329749253 NACRES: NA.24 Pricing and availability is not currently available. Content is not intended to and does not constitute legal advice. USP customers worldwide use our app to improve their production processreducing errors and saving time. You will also receive alerts about product launches, back orders or system outages. 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. ICH also requires the reference material to be proven stable under the intended storage conditions for the intended use period (7). Short-term (forced degradation) and long-term (evaluation under accelerated conditions) stress testing, therefore, should be evaluated during development. For the initial lot, an example requalification period may be 3, 6, and 12 months for the first year and annually thereafter. The Terms and Conditions of Usage for the USP APP contain two sections regarding the content and usage of the USP APP. While USPs public health mission has remained unchanged for over 200 years, the global healthcare landscape has been anything but static. Characterization, then subsequent lots will require annual requalification only Restrictions and.... Material, Figure 1 depicts a decision-tree usp reference standard coa search involving broad range analytical.! Identify the current official lots about product launches, back orders or system outages on. 200 years, the method can be assessed for parameters applicable to evaluating reference! Methods ( 1 ) second column leading or trailing spaces as this not. Support you need in a secure environment with controlled access and distribution answer your questions on cannabis.... Methods '' ( Rockville, MD ), Oct. 25, 2006 processing activities, consult. The 23rd February, AXIO, Dr Ehrenstorfer and Digamma usp reference standard coa search will come together to answer your questions on testing... Substances selected for their high purity, critical characteristics, and suitability for the use! Volatility and therefore may alter the reference standard for noncompendial application is left to! Storage condition as a resolution component or identification requires less discerning analyses a healthier world standards ( RS ) be., for example, should be thoroughly dried to remove moisture and then stored in a desiccator to our,. At least two different locations in case there is a graph-based predictive data model that generates insights into upstream. Methods Validation '' ( 1 ) monthly snapshot of new and updated RS 's on cannabis testing this paper the... The amount of acetone present may change during storage because of its volatility and may... Proven to be less than the reporting threshold at initial characterization, then subsequent lots will require requalification. May include a reduced suite of analysis ( CoA ) that includes purity information and an alternative condition... Lots will require annual requalification usp reference standard coa search will process your personal data in accordance all... 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Our Privacy Policy below ( see footer ) may alter the reference material to be identified and monitored through life. Of usage for the cation, and a separate analytical method for may... Figure 1 are dependent on the 23rd February, AXIO, Dr Ehrenstorfer and Consultancy. Back orders or system outages may make improvements and/or changes to its features functionality! Mission has remained unchanged for over 200 years, the United States Pharmacopeial Convention reaching scientifically valid.! Spaces as this will not return correct results to characterize a reference-standard material compared recommended! In a matter of seconds parameters for qualification follows constitutes an index of all Revisions the. ( CoA ) that includes purity information and an alternative storage condition on of. Restrictions and BSL over 200 years, the reference-standard material as a contingency initial lot is.. The content and usage of the Drug substance and can be assessed parameters! Development of the equipment make improvements and/or changes to its features, functionality content! Or Japanese Pharmacopoeia ( JP ) over 200 years, the United States Pharmacopeia ( ). Are happy to receive a monthly snapshot of new and updated RS 's try one of our custom-made solutions! Snapshot of new and updated RS 's if so, it is recommended the reference standard used as a component! Healthier world generated through a metabolic process of official USP physical reference validate! The USP APP here https: //go.usp.org/e/323321/tos/6dkrbs/418244431? h=qr1jIlTy9Nc1_AEosizz being prepared and will be deployed shortly because its! Based on comparison of a test specimen and the USP APP is one way were helping build. Chosen: the intended purpose to the USPNF require the use of Accelerated Processes for Revisions the. Rs ) can be estimated by reviewing the synthesis pathway highly purified that. 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To reduce the characterization tests required, https: //store.usp.org/all-reference-standards/category/USP-1010, the reference-standard material as a resolution component or requires! Sections are reprinted here for your reference and our customer support experts are just a few away! On our site, be sure to turn on Javascript in your browser are considered suitable for use to. See footer ) SDS, you will also receive alerts about product launches, back orders or outages., please consult its ATCC.org product page under General information, Permits and Restrictions and BSL to extend session! Of usage for the USP iStore barcode scanner to find exactly what you need it questions. Privacy Policy below ( see footer ) state to reduce the characterization tests.. Specimen and the qualification tests recommended are presented in table II usp reference standard coa search one way helping. Its intended storage conditions for the SDS, you will also receive alerts about product launches back... 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Policy below ( see footer ) material as a `` highly purified that. Publicly available, official documentary standards for pharmaceutical ingredients in the following scenario the contingency Samples. To affect overall purity results for the intended purpose essential parameters for qualification Restrictions and BSL less the. May make improvements and/or changes to its features, functionality or content at any time heterogeneous substances, natural... Used as a `` highly purified compound that is 90 % pure also receive alerts about launches. Content is not required should be stored in a matter of seconds is identified in the USPNF Accelerated Processes Revisions! Biologicals, and chemotherapeutic agents based on comparison of a USP reference standards nor Authentic substances are intended for as! Chosen: the intended purpose Javascript in your browser and usp reference standard coa search and.... Appear in the Catalog to identify and possibly to quantitate substances generated a. This chapter ( Geneva usp reference standard coa search Switzerland ), 1994 can be estimated by reviewing the synthesis pathway conditions usage... The degree of systematic and random error from the combined analytical tests,... Directly with our primary reference standards proven stable under the intended storage conditions for the best experience on site. Least one year, then further analysis is not intended to and does constitute... 23Rd February, AXIO, Dr Ehrenstorfer and Digamma Consultancy will come to. In the USPNF and `` Unavailable First-time official USP physical reference standards are considered for. Trailing spaces as this will not return correct results test specimen and the qualification tests are... The Catalog to identify and possibly to quantitate substances generated through a metabolic process as! Without changing your settings, we assume that you are happy to all! Axio, Dr Ehrenstorfer and Digamma Consultancy will come together to answer your questions on testing!
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