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Excerpted USP-NF and FCC Standards: a Hand Sanitizer Resource

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Excerpted USP-NF and FCC Standards: a Hand Sanitizer Resource Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. Excerpted USP-NF and FCC Standards: A Hand Sanitizer Resource A collection of standards provided as a resource to assist with the challenges posed by COVID-19 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. Published August 17, 2020 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. CONTENTS USP Monographs…………………………………………………………………15 • Alcohol • Dehydrated Alcohol • Azeotropic Isopropyl Alcohol • Glycerin • Hydrogen Peroxide Concentrate • Hydrogen Peroxide Topical Solution • Isopropyl Alcohol • Purified Water Excipients………………………………………………………………………… 25 • USP and NF Excipients, Listed by Functional Category NF Monographs…………………………………………………………………. 37 • Denatonium Benzoate • Sucrose Octaacetate Reference Tables……………………………………………………………….. 39 • Alcoholometric Table Food Chemicals Codex……………………………………………………… 119 • Ethyl Alcohol • Glycerin • Hydrogen Peroxide • Isopropyl Alcohol Additional documentary standards are also included in this publication to support these highlighted standards. Published August 17, 2020 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. Published August 17, 2020 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. 3 GENERAL NOTICES AND REQUIREMENTS Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia 1. TITLE AND REVISION................................................. 5 8. TERMS AND DEFINITIONS....................................... 11 8.10. Abbreviations.................................................... 11 2. OFFICIAL STATUS AND LEGAL RECOGNITION........ 5 8.20. About................................................................ 11 2.10. Official Text......................................................... 5 8.30. Alcohol Content................................................ 11 2.20. Official Articles..................................................... 5 8.40. Atomic Weights................................................. 11 2.30. Legal Recognition................................................ 5 8.50. Blank Determinations........................................ 12 8.60. Concomitantly................................................... 12 3. CONFORMANCE TO STANDARDS............................. 5 8.70. Desiccator......................................................... 12 3.10. Applicability of Standards.................................... 5 8.80. Logarithms........................................................ 12 3.20. Indicating Conformance...................................... 6 8.90. Microbial Strain................................................. 12 8.100. Negligible........................................................ 12 4. MONOGRAPHS AND GENERAL CHAPTERS.............. 7 8.110. NLT/NMT........................................................ 12 4.10. Monographs........................................................ 7 8.120. Odor............................................................... 12 4.20. General Chapters................................................. 7 8.130. Percent............................................................ 12 8.140. Percentage Concentrations.............................. 12 5. MONOGRAPH COMPONENTS................................... 7 8.150. Pressure........................................................... 12 5.10. Molecular Formula............................................... 7 8.160. Reaction Time.................................................. 12 5.20. Added Substances............................................... 7 8.170. Specific Gravity................................................ 12 5.30. Description and Solubility.................................... 8 8.180. Temperatures.................................................. 12 5.40. Identification....................................................... 8 8.190. Time................................................................ 12 5.50. Assay................................................................... 8 8.200. Transfer........................................................... 12 5.60. Impurities and Foreign Substances....................... 9 8.210. Vacuum........................................................... 12 5.70. Performance Tests............................................... 9 8.220. Vacuum Desiccator.......................................... 12 5.80. USP Reference Standards..................................... 9 8.230. Water.............................................................. 13 8.240. Weights and Measures..................................... 13 6. TESTING PRACTICES AND PROCEDURES................. 9 6.10. Safe Laboratory Practices..................................... 9 9. PRESCRIBING AND DISPENSING............................. 14 6.20. Automated Procedures........................................ 9 9.10. Use of Metric Units............................................ 14 6.30. Alternative and Harmonized Methods and Procedures.......................................................... 9 10. PRESERVATION, PACKAGING, STORAGE, AND 6.40. Dried, Anhydrous, Ignited, or Solvent-Free Basis 10 LABELING.................................................................. 14 6.50. Preparation of Solutions..................................... 10 10.10. Packaging and Storage.................................... 14 6.60. Units Necessary to Complete a Test................... 10 10.20. Labeling.......................................................... 14 6.70. Reagents........................................................... 10 6.80. Equipment......................................................... 11 7. TEST RESULTS.......................................................... 11 7.10. Interpretation of Requirements.......................... 11 7.20. Rounding Rules................................................. 11 Published August 17, 2020 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. Published August 17, 2020 Not official text. Please refer to the currently official version of the applicable USP–NF or FCC standard for compliance purposes. 5 GENERAL NOTICES AND REQUIREMENTS The General Notices and Requirements section (the General 2.20. Official Articles Notices) presents the basic assumptions, definitions, and An official article is an article that is recognized in USP or NF. default conditions for the interpretation and application of the An article is deemed to be recognized and included in a United States Pharmacopeia (USP) and the National Formulary compendium when a monograph for the article is published (NF). in the compendium and an official date is generally or Requirements stated in these General Notices apply to all specifically assigned to the monograph. articles recognized in the USP and NF (the “compendia”) and The title specified in a monograph is the official title for such to all general chapters unless specifically stated otherwise. article. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles. For drug products that incorporate a sensor to detect that the product Change to read: has been administered, the official title shall be the title 1. TITLE AND REVISION specified in the relevant drug product monograph plus the ▲ words “with sensor”. The full title of this joint compendium is The Pharmacopeia Official articles include both official substances and official of the United States of America and the National Formulary products. An official substance is a drug substance, excipient, Online (USP–NF Online). Although USP and NF are published dietary ingredient, other ingredient, or component of a together and share these General Notices, they are separate finished device for which the monograph title includes no compendia. This is the 43rd revision of the USP and 38th indication of the nature of the finished form. edition of the NF. The final print publication of the USP–NF is An official product is a drug product, dietary supplement, USP 43–NF 38, after which official standards are published compounded preparation, or finished device for which a only in the USP–NF Online. Where the terms “USP,” “NF,” or monograph is provided. “USP–NF” are used without further qualification, they refer to 2.30. Legal Recognition the currently official standard.▲ (USP 1-Aug-2020) The USP and NF are recognized in the laws and regulations of many countries throughout the world. Regulatory authorities may enforce the standards presented in the USP Change to read: and NF, but because recognition of the USP and NF may vary 2. OFFICIAL STATUS AND LEGAL RECOGNITION by country, users should understand applicable laws and regulations. In the United States under the Federal Food, Drug, 2.10. Official Text and Cosmetic Act (FDCA), both USP and NF are recognized as Official text of the USP and NF is published in the USP–NF ▲ official compendia. A drug with a name recognized in USP–NF Online (www.uspnf.com). ▲ (USP 1-Aug-2020) must comply with compendial identity standards or be Routine revisions are published in the USP–NF Online and deemed adulterated, misbranded,
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