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Frequently Asked QuestionsUse and applicationsAre USP Reference Standards suitable for use as drugs or medical devices?USP Reference Standards are intended for Test and Assay use only, they are not intended for administration to humans or animals as drugs or medical devices. (View USP's policy statement on the storage and usage of Reference Standards. Are USP Reference Standards suitable for applications not specified in the USP–NF?You may be able to use USP Reference Standards for analytical or laboratory applications other than those specified in the USP–NF but you are responsible for determining the suitability of the standards for the required purposes. USP Reference Standards may not be used as drugs or for diagnostic purposes. How do I determine if a Reference Standard has expired or is still valid for use?In order to determine the current status of a USP Reference Standard, please consult the Official USP Reference Standards Catalog, published bimonthly as a stand-alone document. You can also consult the online Reference Standards catalog, also published bimonthly. USP Reference Standards do not carry expiration dates in the traditional sense. Rather, they are granted Official Status under the authority of the United States Pharmacopeial Convention Board of Trustees upon recommendation of the USP Reference Standards Expert Committee. (View USP's policy statement on expiration dating of Reference Standards. If the lot number indicated on the label of your Reference Standard matches the number in the Current Lot column of the product listing or catalog, it means that your Reference Standards are valid for use. If the Reference Standard you are using is not from the current lot, check the Previous Lot/Valid Use Date column. This column identifies the expiration dates for lots no longer being distributed. The last day of the indicated month represents the expiration date for the specified lot (e.g., "F-1 06/02" means lot F-1 was considered official through June 30, 2002). How long is the previous lot valid for use after a new lot is developed?Please consult the Official USP Reference Standards Catalog, published bimonthly as a stand-alone document. Two columns appear in the catalog to identify the current official lots. One column identifies the official lot currently being shipped by USP. If the field is blank, then the current lot is not in distribution. In some cases, the previous lot may still be considered official. If this is the case, it is identified in the second column. Ordinarily, the previous lot is carried in official status for one year after the current lot has been depleted, unless, because of a change in monograph requirements or stability limitations, the previous lot is found to be no longer suitable for its intended use. Indication is given for the month and year through which previous lots may be used. (View USP's policy statement on expiration dating of Reference Standards. Do USP Reference Standards require any special preparation before use?Any specific directions for storage and use are provided on the label of the Reference Standard. Some standards can be used as-is but others may require drying before use or correction of the labeled valued with a concurrent moisture or Loss on Drying determination. Additional information on special preparation requirements for USP Reference Standards may be found in General Chapter <11> USP Reference Standards. Why is USP not requiring annual recertification of the USP Near Infrared System Suitability Reference Standard?The USP Near Infrared System Suitability Reference Standard does not require recertification due to a combination of the component material, a proprietary housing and seal, and USP's commitment to a continuous suitability for use program. For more details, download our official statement. Shipping and StorageWhere can I find information on labeling and storage of USP Reference Standards?USP's policy is to include proper storage conditions for unopened Reference Standards on the container label. Storage conditions are lot specific. USP generally provides enough material for multiple preparations. Any unused portions remaining after the container has been opened should be carefully stored in accordance with prudent laboratory procedures. There are many variable outside of the control of USP. Therefore, USP makes no warranties concerning the continued suitability of previously opened Reference Standards. Decisions concerning the proper use of previously opened Reference Standards are the responsibility of the purchaser. (View USP's policy statement on the storage and usage of Reference Standards. Labeling and storage information for USP Reference Standards is also provided in General Chapter <11> USP Reference Standards of USP 26–NF 21. If the specific label instructions differ from the instructions in USP–NF (this may happen if the labels are updated before a new edition of USP–NF is published), the instructions on the label take precedence. Do USP Reference Standards require special shipping?USP Reference Standards are not customarily shipped on ice or under refrigerated conditions. The storage conditions noted on the Reference Standard vial or packaging are intended to preserve the integrity of the Reference Standard during long-term storage. Normal shipping conditions and transit times, including international shipping of Reference Standards, have not been demonstrated to affect their suitability for use. If scientific evidence suggests the need to ship a Reference Standard on ice, USP will do so. (View USP's policy statement on shipping of Reference Standards. Performance Verification TabletIn using a performance verification tablet, how do we address a variance from the official ranges?If necessary, contact USP Reference Standards Technical Service at +1-301-816-8129 or . AvailabilityWhat happens if a new Reference Standard specified in a monograph is not yet available from USP?Requirements in any new standards, tests, or assays in the USP–NF will not go into effect unless the specified USP Reference Standards are available from USP. The availability of new Reference Standards and the official dates of the USP–NF standards, tests, or assays requiring their use are announced in USP–NF or its Supplements, or in the Interim Revision Announcements published in USP's Pharmacopeial Forum journal. To learn when a particular, new, first time Reference Standard becomes available, use the New Reference Standards Release Notification Program. What if an existing Reference Standard is currently not available from USP?The availability of USP Reference Standards is generally better than 99% and we strive to plan ahead to replace depleted lots in a timely manner. We project a depletion date for each Reference Standards lot based on historic trends. However, despite our best efforts, some Reference Standards might occasionally be out of stock temporarily. Contact your USP Account Manager or Reference Standards Technical Service to find out when the specific Reference Standards you're looking for might become available again. You can also frequently check the product listings on USP's e-store or sign up for our email notices, which will keep you informed about Reference Standards that become available. Send an email to if you'd like to sign up for the email notice service. You can place an order now for Reference Standards that are not currently in stock. Products that become available within 30 days of your order will automatically be shipped to you. If the products become available after 30 days, USP will send you a Notice of Availability to get your confirmation before shipping the order. GeneralDoes USP issue certificates of analysis for USP Reference Standards?USP provides Material Data Safety Sheets (MSDS) for all Reference Standards and USP Certificates for some Reference Standards. These certificates do not completely describe the test results obtained during evaluation for scientific and legal reasons. Rather, the certificates are issued to provide customers with a hardcopy of the USP label text of the standard. These certificates, when available, can be viewed on our Web site by clicking on the Product Description link for an item in our online catalog. (View USP's policy statement on certificates of analysis for Reference Standards What is the specific purity of individual USP Reference Standards?Unless otherwise specified on the label, all USP Reference Standards are 100.0% pure for compendial use in quantitative applications. The USP catalog contains the labeled values for every current lot. These labeled values are only intended for specific quantitative USP–NF applications. For more information, contact RS Technical Service at How do USP units convert to International Units?USP Endotoxin units are identical to International Units. Relationships for other USP Reference Standards must be determined on a case by case basis. If you need help, call 1-800-227-8772 or +1-301-881-0666 and ask to speak to a scientific staff member. |
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