|
|
Information For:
|
Frequently Asked Questions
GeneralDoes USP issue Certificates of Analysis (COAs) for USP Reference Standards?With the exception of CRMs, USP does not provide COAs. All information for official uses of a Reference Standard is on the label of the standard and where needed, in the additional data sheets shipped with the standard. USP does provide Material Safety Data Sheets (MSDS) for all Reference Standards and USP Certificates for some Reference Standards. USP 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 hard copy 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 intended for only 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. Use 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?To determine the current status of a USP Reference Standard, please consult the official USP Reference Standards Catalog, published bimonthly online and every four months in print. 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 online and every four months in print. 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 the previous lot is found to be no longer suitable for its intended use because of a change in monograph requirements or stability limitations. The catalog indicates 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. See Use and Storage for more details. 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 because of 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. Many variables are 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 USP 26–NF 21 General Chapter <11> USP Reference Standards. 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. See Use and Storage for more details. 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 TabletsIn using a performance verification tablet, how do we address a variance from the official ranges?View the Dissolution Toolkit for more information 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. To learn when a particular new Reference Standard becomes available for the first time, 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 percent 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 are 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. To sign up for the email notice service, email . 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 be shipped to you automatically. If the products become available after 30 days, USP will send you a Notice of Availability to get your confirmation before shipping the order. Certified Reference MaterialsWhat is a USP Certified Reference Material (CRM)?A USP Certified Reference Material (CRM) is a USP Reference Standard with a "pedigree." It should be used as a USP Reference Standard. A CRM is a special class and the next generation of a USP Reference Standard that has undergone additional metrologically based testing and statistical analysis. The USP CRM is issued with a Certificate of Analysis (COA), listing a certified property value with its associated uncertainty, expiration date, and other information, according to ISO Guide 31[1]. The one or more property values are certified by a procedure that establishes its traceability to an accurate realization of the unit in which the property values are expressed [2].
How do I use a CRM?Since a USP CRM is a USP Reference Standard, it should be used in the same way in which you would use a USP Reference Standard. The user should follow the current monograph and label instructions. What should I do with my past and future results, if I am a current purchaser of a USP Reference Standard that has now become a USP CRM? What should I do with my past and future results, if I am a current purchaser of a USP Reference Standard that has now become a USP CRM?Nothing needs to be done concerning past and future results, since a CRM is also a Reference Standard. A measurement uncertainty may be calculated using information from the USP COA and your experimental data, if appropriate. What should I do about the uncertainty of my house standard, if I use the USP Reference Standard to make the house standard?You may propagate the uncertainty of your house standard using the standard uncertainty of the USP CRM [3, 4]. Why is USP authorized to produce CRMs?USP is ISO Guide 34 accredited as a Reference Material producer (RMP) of Chemical CRMs. Why is USP producing CRMs?USP is the first global pharmacopeia to produce CRMs to meet the increasingly demanding measurement needs of the industry. USP has always produced quality reference materials and the CRMs are a further improvement in the final product by advancing the metrological science of our Reference Standards. The purpose of the CRMs is to provide a higher degree of confidence in the analytical measurement that leads to decisions regarding product specification and acceptance limits. What are the benefits of a USP CRM?A USP CRM is a means to establishing trueness and traceability to the measurement system, thereby allowing and enabling consistency and comparability of measurements and results over periods of time and among laboratories. Traceability and uncertainty of measurement are important components in the documentation for ISO 17025 requirement for testing labs. What do I do with the certificate? What do I do with the certified property value and the uncertainty value?The CRM COA provides confidence in the property value(s), measurement traceability, and internal and external quality assurance. The CRM certified property value may be used for calibration, comparison, or value assignment. The CRM user is able to propagate uncertainty to the final result, and is able to make meaningful comparisons of measurement results. Is there a difference between acceptance criteria and certified property value and uncertainty (CRM)?The acceptance criteria and certified property value and uncertainty (CRM) are completely different concepts derived from different principles. The CRM provides trueness of measurement, an assigned value and how far from that value the actual value can be with a stated level of confidence. The monograph limits are specified in the appropriate USP–NF monograph. Acceptance criteria are determined by the customer. The CRM contributes neither to the product specification nor the acceptance criteria. The proper implementation and integration of a CRM into the measurement process lends assurance the specifications and acceptance criteria are met. Does the USP CRM cost more than the USP Reference Standard?Initially, the price of the USP CRM will be the same as the USP Reference Standard. This improvement in the final product is presently an additional bonus to your purchase at USP Reference Standard prices. How many more USP CRMs will be available for purchase?USP is committed to producing CRMs, and you can expect to find more available to purchase each year. What if the COA is lost or removed from the packaging?A copy of the certificate is available on the Reference Standards Web site listings; select the CRM name and then click on "View" next to "USP Certificate." May I buy just the USP RS without the certificate?If the CRM is available, the reference material will be sold only as a CRM. Why does a USP CRM have an expiration date (period of validity) and what does the expiration date mean?The expiration date (period of validity) of a CRM is required by ISO Guide 31 [1]. The CRM property value and uncertainty is applicable to the unopened vial for the stated period of validity. It is expected that the USP Reference Standard will be used when opened. 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. Many variables are outside of the control of USP. Therefore, USP makes no warranties concerning the continued suitability of previously opened Reference Standards, hence CRMs. Decisions concerning the proper use of previously opened Reference Standards are the responsibility of the purchaser. If a CRM/Reference Standard lot is exhausted, which expiration date should be used, the valid use date of the Reference Standard/CRM lot or the COA period of validity?If a CRM/Reference Standard lot is exhausted, the earlier date takes precedence. For example, if the valid use date of a USP Reference Standard/CRM is September 2009 and the CRM COA is September 24, 2010, the valid use date of September 2009 should be used. The date that comes first (valid use date or period of validity) always takes precedence. The CRM certified property value is valid for the stated period of validity on the CRM COA. If the valid use date comes before the CRM COA period of validity and the valid use date has past, the material is no longer a Reference Standard and cannot be used for official compendial uses. FDA requirements for an official Reference Standard would not be met. However, the material may be used as a CRM (i.e., check standard). References:
AnnouncementsChanges to the Dissolution Performance Verification Test (11/20/09) Newly Released: Sertraline and its related compounds (05/05/09)Related ResourcesContact InformationFor TECHNICAL SUPPORT, contact or +1–301–816–8129. |
||||||||||||||||||||||||||||
Copyright © 2009 The United States Pharmacopeial Convention
|
|||||||||||||||||||||||||||||
