如何使用USP(美国药典)对照品

Uses of USP Reference StandardsUSP Reference Standards are integral components of mono-graphs and other documentary standards established by USPto help ensure the identity, strength, quality, and purity of medi-cines and foods, and are provided primarily for quality control use in conducting the assays and tests in these documentary standards. USP Reference Standards are specified for use in pharmacopeial assays and tests in the official standards publication, the United States Pharmacopeia–National Formulary (USP–NF), and help ensure compliance with the official, FDA-enforceable quality requirements in the USP–NF. USP Reference Standards are specified for use in the effective monographs of the Food Chemicals Codex. USP Reference Standards also lend themselves to other applications, including measurements required to obtain accurate and reproducible results in modern chromatographic and spectrophotometric methods. USP Reference Standards are not to be used as drugs, dietary supplements, or medical devices. To serve its intended purpose, each USP Reference Standard must be properly stored, handled, and used. Users of USP Reference Standards should refer to General Chapter <11> in the USP–NF.Rigorous Testing and Quality ControlUSP Reference Standards are selected for their high purity, critical characteristics, and suitability for the intended purpose. For quantitative Reference Standards, assigned values can be found on the label. If a value is not provided on the label or accompanying documentation and the Reference Standard has a quantitative USP compendial application, a value of 100.0% is used. This applies only to USP Reference Standards intended for quantitative use in USP compendial procedures. The assigned value is not applicable for qualitative uses. Please refer to a USP Reference Standard’s USP compendial application(s) to determine if the Reference Standard is used qualitatively and/or quantitatively. An explanation of how the values are calculated can be found in the “How to Read” section.USP Reference Standards are established through a processof rigorous testing, evaluation, and quality control. They are collaboratively tested in multiple laboratories. The Reference Standards are released under the authority of USP’s Board of Trustees. Heterogeneous substances of natural origin are also designated ‘‘Reference Standards’’ where needed. Usually these are the counterparts of international standards. Reference Standards CategoriesUSP offers more than 3,500 Reference Standards for pharmaceuticals, excipients, dietary supplements, andfood ingredients. This website features a full list of available USP Reference Standards, with information updated daily. The list includes¡ R eference Standards specified by the current officialedition of the USP–NF¡ R eference Standards specified by Pending Monographsand Non-U.S. Monographs¡ R eference Standards specified in proposed revisionsto USP–NF or FCC and published in the PharmacopeialForum or FCC Forum¡ R eference Standards specified in the current edition ofthe Food Chemicals Codex¡ R eference Standards for substances of abuse, requiredby analytical, clinical, pharmaceutical, and researchlaboratoriesThe distribution of controlled substances is subject to the regulations and licensing provisions of the Drug Enforcement Administration of the U.S. Department of Justice. USP also collaborates with the World Health Organization in its program to provide international biological standards and chemical reference materials for antibiotics, biologicals, and chemo-therapeutic agents. Some USP Reference Standards are stan-dardized in terms of the corresponding international standards. Where to Find Information on USP–NF Reference Standards ¡ I ndividual USP or NF monographs as well as certainGeneral Chapters specify the USP Reference Standard(s) required for assay and test procedures. General Chapter<11> USP Reference Standards provides general informa-tion and instructions for proper use and storage. Consultthe label text for proper use and handling of individualReference Standards.¡ C onsult the updates to Reference Standards informationprovided in the New Official Text section of USP’s website.¡ F or the most up-to-date availability and lot information,please consult our online store at .¡ A nswers to several Frequently Asked Questions areavailable on our website at /support-home/frequently-asked-questions/reference-standards.Suitability for Use¡ U sers must ascertain that the Reference Standards theyare using are from a valid lot.¡ U sers must determine the suitability of ReferenceStandards for applications and uses not in the USP–NF,Food Chemicals Codex, or USP Dietary SupplementsCompendium. Any non-compendial use is at thepurchaser’s sole risk and expense.Storing¡ E nsure that the USP Reference Standards are stored intheir original stoppered containers, according to anyspecial label directions, away from heat and humidity,and protected from light. The storage condition for anunopened USP Reference Standard can typically befound on the container label. Storage conditions are nolonger provided in the Safety Data Sheets (SDS). Instead, the SDS refers users to the USP Reference Standard label.Storage conditions are lot-specific and may changefrom one lot to another. If no specific directions or limita-tions are provided on the USP Reference Standard label, the conditions of storage shall include storage at roomtemperature and protection from moisture, light, freez-ing, and excessive heat. Refer to General Chapter <659> Packaging and Storage Requirements in the USP–NF fordefinitions of storage and handling terms.Weighing¡ E nsure that Reference Standard substances are accu-rately weighed—taking due account of relativelylarge potential errors associated with weighing smallmasses—where it is directed that a standard solution ora standard preparation be prepared for a quantitativedetermination. See the current official edition of USP–NFGeneral Chapters <41> Weights and Balances and <31>Volumetric Apparatus, and USP–NF General Notices forinformation regarding appropriate use of USP ReferenceStandards.Drying¡ U se a clean and dry vessel, and not the original contain-er, as the drying vessel where a USP Reference Standard is required to be dried before use.¡ M ake sure not to dry a specimen repeatedly attemperatures above 25 degrees Celsius.¡ F ollow any special drying requirements specified on theReference Standards label or in specific sections of USPor NF monographs.¡ F ollow Method I under USP–NF General Chapter <921>Water Determination where the titrimetric determination of water is required at the time a Reference Standardis to be used. Instrumental or microanalytical methodsare acceptable for this purpose. When using typicalamounts, about 50 mg of the Reference Standard,titrate with a two- to five-fold dilution of the reagent.How to Read Product ListingsColumn 1 (Catalog Number): Catalog number currently assigned to each Reference Standard. Please include this number in your order.Column 2 (Description): Product description as designatedin USP–NF, the product label, and/or the Drug Enforcement Administration Control Schedule, as applicable. The quantityof material per container follows the name in parentheses. (All materials are in single containers unless otherwise specified.)Column 3 (Current Lot): Current lot designation of eachofficial item being distributed as of the date of this catalog.If the current lot is blank, the item is not in distribution.Column 4 (Previous Lot/Valid Use Date): Lot designations for recent lots no longer being distributed. The indicated month and year in parentheses indicate the date (last day of the month) through which that lot was valid as a USP Reference Standard (e.g., ‘‘F-1 (06/00)’’ means lot F-1 is no longer being distributed, but was considered valid through June 30, 2000).Column 5 (CAS Number): Chemical Abstracts Service number, when available, for USP Reference Standards. For mixtures, typically, the CAS number of the analyte of interest is listed. CAS number is for information only. USP does not assign CAS numbers to chemicals. USP information should not be used to assign CAS numbers.Column 6 (NDC Number): National Drug Code at USP—An 11 digit (3 Segment) number that is a product identifier used to distinguish controlled substances at USP for DEA reporting purposes. The first segment (Labeler Code) identifies the company, the second segment (Product Code) references the product, and the third segment (Package Code) indicates the package size.Column 7 (Price): List price of the Reference Standard.Column 8 (Special Restrictions): Lists any special shippingor ordering conditions for an P Reference Standards Catalog FormatsUSP offers the following Reference Standards Catalog options:¡ U SP Daily Reference Standards Catalog: Printable PDF and Excel listing of USP Reference Standards that is updateddaily. English only. View at /rs-catalog¡ U SP Store: For the most up-to-date USP Reference Standard lot listings, and to purchase Reference Standards, pleasevisit our online store at .HOW TO USE THE CATALOG。