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USP REFERENCE STANDARDS To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with ourprimary
OUR SCIENCE
Our Science. Pharmaceutical science expertise, of our staff and world-wide volunteer experts, is the foundation of USP’s work to help advance public health and ensure the quality and safety of medicines, dietary supplements and foods. The quality standards we develop help manufacturers deliver safe products to billions of peopleworldwide.
THE LAST-MILE MANUFACTURING OF VACCINES 3 Th ast-mil anufacturin accines: Recommendations for scaling-up production of COVID-19 vaccines in Africa I. Background Before the SARS-CoV-2 pandemic, Africa was facing DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatus performance. PVT is a holistic test and by using the reference standard material and the standard procedure, laboratories can compare results from their instrument with other laboratories worldwide. USP COMPOUNDING STANDARDS AND BEYOND-USE DATES (BUDS) USP Compounding Standards and Beyond-Use Dates (BUDs) June 3, 2019 Comparing BUDs between the official and the revised The revised chapter addresses Compounded Nonsterile Preparations (CNSPs) requiringshorter BUDs and
561 ARTICLES OF BOTANICAL ORIGIN Crude Fiber Exhaust a weighed quantity of the Test Sample, representing about 2g of the drug, with ether.Add 200 mL of boiling dilute sulfuric acid (1 in 78) to the ether-exhausted marc, in a 500-mL flask, and connect the flask to a reflux condenser. DEXAMETHASONE (125 MG) Catalog # 1176007: Current Lot R123C0: Previous Lot R07830 (Valid Use Date: 28-FEB-2021) SDS View: USP Certificate for Current Lot711 DISSOLUTION
Stage 6 Harmonization 2 〈711〉 Dissolution Official December 1, 2011 Figure 1. Basket Stirring Element 2S (USP34) of 25±2 mm between the bottom of the blade and theinside bottom of the vessel is maintained during the test. 905 UNIFORMITY OF DOSAGE UNITS USP34 Stage 6 Harmonization 2 〈905〉 Uniformity of Dosage Units Official December 1, 2011 in conditions of normal use, and express the results as de-in which the terms are as defined in Table 2. livered dose. U.S. PHARMACOPEIAABOUT U.S. PHARMACOPEIAREFERENCE STANDARDSSTORECOMPOUNDINGUSP 795OUR IMPACT We are dedicated to helping improve global health through standards setting in compounding, biologics, pharmaceutical manufacturing andother fields.
USP REFERENCE STANDARDS To confirm accuracy and reproducibility, USP Reference Standards are rigorously tested and evaluated by multiple independent laboratories including USP, commercial, regulatory, and academic labs. We also provide publicly available, official documentary standards for pharmaceutical ingredients in the USP–NF that link directly with ourprimary
OUR SCIENCE
Our Science. Pharmaceutical science expertise, of our staff and world-wide volunteer experts, is the foundation of USP’s work to help advance public health and ensure the quality and safety of medicines, dietary supplements and foods. The quality standards we develop help manufacturers deliver safe products to billions of peopleworldwide.
THE LAST-MILE MANUFACTURING OF VACCINES 3 Th ast-mil anufacturin accines: Recommendations for scaling-up production of COVID-19 vaccines in Africa I. Background Before the SARS-CoV-2 pandemic, Africa was facing DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatus performance. PVT is a holistic test and by using the reference standard material and the standard procedure, laboratories can compare results from their instrument with other laboratories worldwide. USP COMPOUNDING STANDARDS AND BEYOND-USE DATES (BUDS) USP Compounding Standards and Beyond-Use Dates (BUDs) June 3, 2019 Comparing BUDs between the official and the revised The revised chapter addresses Compounded Nonsterile Preparations (CNSPs) requiringshorter BUDs and
561 ARTICLES OF BOTANICAL ORIGIN Crude Fiber Exhaust a weighed quantity of the Test Sample, representing about 2g of the drug, with ether.Add 200 mL of boiling dilute sulfuric acid (1 in 78) to the ether-exhausted marc, in a 500-mL flask, and connect the flask to a reflux condenser. DEXAMETHASONE (125 MG) Catalog # 1176007: Current Lot R123C0: Previous Lot R07830 (Valid Use Date: 28-FEB-2021) SDS View: USP Certificate for Current Lot711 DISSOLUTION
Stage 6 Harmonization 2 〈711〉 Dissolution Official December 1, 2011 Figure 1. Basket Stirring Element 2S (USP34) of 25±2 mm between the bottom of the blade and theinside bottom of the vessel is maintained during the test. 905 UNIFORMITY OF DOSAGE UNITS USP34 Stage 6 Harmonization 2 〈905〉 Uniformity of Dosage Units Official December 1, 2011 in conditions of normal use, and express the results as de-in which the terms are as defined in Table 2. livered dose. SEARCH & BUY REFERENCE STANDARDS Search & Buy Reference Standards. The following list of RSs have been assigned a Valid Use Date of October 31, 2020. Due to revisions to USP General Chapter and General Notices. 5.80, which will become official November 1, 2020, users will no longer be able to assume a value of 100.0% for these RS lots in quantitative USP compendial COVID-19 VACCINE HANDLING TOOLKIT The COVID-19 Vaccine Handling Toolkit is an informational resource and is intended to complement the following resources as well as those provided by the CDC, U.S. FDA, vaccine manufacturers, and state and local departments of health: CDC Vaccine Storage and Handling Official toolkit (February 5, 2021) LOGIN - USP ACCESS POINT Welcome to Access Point! Use your USP Access Point login credentials to register for events and courses, access your subscriptions to USP's free resources, applications, and more. Note: Please do not bookmark this page. Refer to FAQs. Click here for Access Point Tutorial Create a new USP Access Point account, if you do not have one. SUPPORTING THE GLOBAL HEALTH RESPONSE TO COVID-19 Supporting the global health response to COVID-19. As a standards-setting public health organization that sits at the intersection of the pharmaceutical, regulatory, manufacturing, education and research sectors, USP is marshaling its technical expertise to help the global community respond to COVID-19. This includes facilitating the supply of USP COMPOUNDING STANDARDS USP Compounding Standards. USP provides three types of public quality standards for compounding: These standards are developed by the USP Compounding Expert Committee to help ensure the quality of compounded medicines. USP standards—general chapters and monographs—contained in the United States Pharmacopeia and the National Formulary (USP COVID-19 VACCINE HANDLING TOOLKIT MAXIMIZING DOSES OF V a ci n e o d i u m C h l o r i d S. 5 1. 5 2. 5 5 3 V a c c i n e. 5 0 5 1. 5 2. 5 5 3 V a ci n e Dilution Date/Time: V a c c i n e. 5 1. 5 2. 5 5 3 HQS162F_2021-01 The standard of trust Dilute the vaccine Continued on next page COVID-19 VACCINE HANDLING TOOLKIT TRANSPORTING COVID-19 HQS162F_2021-01 The standard of trust Pfizer-BioNTech COVID-19 Vaccine 2 Moderna COVID-19 Vaccine3 Janssen Ad26 COVID-19 Vaccine 4 Janssen is a subsidiary of Johnson & Johnson Temperature* Maximum allowable storage time** Temperature* DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatus performance. PVT is a holistic test and by using the reference standard material and the standard procedure, laboratories can compare results from their instrument with other laboratories worldwide. POTASSIUM GLUCONATE (200 MG) Purchase Potassium Gluconate Reference Standard, 200 mg, USP-1550001, CAS 299-27-4. Specified for use in official USP-NF dietary supplement tests and assays. Order direct for USP service and support. View SDS, current lot data, and more. SALICYLIC ACID (125 MG) Catalog # 1609002: Current Lot K0F112: Previous Lot J3C400 (Valid Use Date: 31-DEC-2007) SDS View: USP Certificate for Current Lot U.S. PHARMACOPEIAABOUT U.S. PHARMACOPEIAREFERENCE STANDARDSSTORECOMPOUNDINGUSP 795OUR IMPACT We are dedicated to helping improve global health through standards setting in compounding, biologics, pharmaceutical manufacturing andother fields.
USP REFERENCE STANDARDS USP standards for drug reference standards are used to demonstrate identity, strength, purity and quality for medicines, dietary supplements and food ingredients.OUR SCIENCE
Pharmaceutical science expertise, of our staff and world-wide volunteer experts, is the foundation of USP’s work to help advance public health and ensure the quality and safety of medicines, dietary supplements and foods. LOGIN - USP ACCESS POINT Welcome to Access Point! Use your USP Access Point login credentials to register for events and courses, access your subscriptions to USP's free resources, applications, and more. THE LAST-MILE MANUFACTURING OF VACCINES 3 Th ast-mil anufacturin accines: Recommendations for scaling-up production of COVID-19 vaccines in Africa I. Background Before the SARS-CoV-2 pandemic, Africa was facing DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatusperformance.
USP COMPOUNDING STANDARDS AND BEYOND-USE DATES (BUDS) USP Compounding Standards and Beyond-Use Dates (BUDs) June 3, 2019 Comparing BUDs between the official and the revised The revised chapter addresses Compounded Nonsterile Preparations (CNSPs) requiringshorter BUDs and
561 ARTICLES OF BOTANICAL ORIGIN Crude Fiber Exhaust a weighed quantity of the Test Sample, representing about 2g of the drug, with ether.Add 200 mL of boiling dilute sulfuric acid (1 in 78) to the ether-exhausted marc, in a 500-mL flask, and connect the flask to a reflux condenser. DEXAMETHASONE (125 MG) Catalog # 1176007: Current Lot R123C0: Previous Lot R07830 (Valid Use Date: 28-FEB-2021) SDS View: USP Certificate for Current Lot CARISOPRODOL CIV (1 G) restricted item please contact usp customer service at 8002278772 or 3018810666 to speak to a customer service representative for orderassistance.
U.S. PHARMACOPEIAABOUT U.S. PHARMACOPEIAREFERENCE STANDARDSSTORECOMPOUNDINGUSP 795OUR IMPACT We are dedicated to helping improve global health through standards setting in compounding, biologics, pharmaceutical manufacturing andother fields.
USP REFERENCE STANDARDS USP standards for drug reference standards are used to demonstrate identity, strength, purity and quality for medicines, dietary supplements and food ingredients.OUR SCIENCE
Pharmaceutical science expertise, of our staff and world-wide volunteer experts, is the foundation of USP’s work to help advance public health and ensure the quality and safety of medicines, dietary supplements and foods. LOGIN - USP ACCESS POINT Welcome to Access Point! Use your USP Access Point login credentials to register for events and courses, access your subscriptions to USP's free resources, applications, and more. THE LAST-MILE MANUFACTURING OF VACCINES 3 Th ast-mil anufacturin accines: Recommendations for scaling-up production of COVID-19 vaccines in Africa I. Background Before the SARS-CoV-2 pandemic, Africa was facing DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatusperformance.
USP COMPOUNDING STANDARDS AND BEYOND-USE DATES (BUDS) USP Compounding Standards and Beyond-Use Dates (BUDs) June 3, 2019 Comparing BUDs between the official and the revised The revised chapter addresses Compounded Nonsterile Preparations (CNSPs) requiringshorter BUDs and
561 ARTICLES OF BOTANICAL ORIGIN Crude Fiber Exhaust a weighed quantity of the Test Sample, representing about 2g of the drug, with ether.Add 200 mL of boiling dilute sulfuric acid (1 in 78) to the ether-exhausted marc, in a 500-mL flask, and connect the flask to a reflux condenser. COVID-19 VACCINE HANDLING TOOLKIT The COVID-19 Vaccine Handling Toolkit is an informational resource and is intended to complement the following resources as well as those provided by the CDC, U.S. FDA, vaccine manufacturers, and state and local departments of health: SUPPORTING THE GLOBAL HEALTH RESPONSE TO COVID-19 USP rapidly responded to shortages of PPE, hand sanitizer and quality medical products by developing a hand sanitizer toolkit for increased availability; supporting scientists, developers and manufacturers of COVID-19 related medical products by providing free access to United States Pharmacopeia-National Formulary (USP-NF) Online; and providing analysis and insights on potential product USP'S COVID-19 VACCINE HANDLING TOOLKIT AND THE LAST 25 FEET To address the gaps identified by front-line healthcare practitioners, USP’s Healthcare Safety & Quality Expert Committee (HSQ EC) led the development of the COVID-19 Vaccine Handling Toolkit, which contains operational considerations 1 for COVID-19 vaccines authorized 2 by the U.S. Food and Drug Administration (FDA). The Toolkit provides individuals preparing and administering vaccines with COVID-19 VACCINE HANDLING TOOLKIT MAXIMIZING DOSES OF V a ci n e o d i u m C h l o r i d S. 5 1. 5 2. 5 5 3 V a c c i n e. 5 0 5 1. 5 2. 5 5 3 V a ci n e Dilution Date/Time: V a c c i n e. 5 1. 5 2. 5 5 3 HQS162F_2021-01 The standard of trust Dilute the vaccine Continued on next page DISSOLUTION PERFORMANCE VERIFICATION TESTING (PVT) The USP Performance Verification Test (PVT) is an integral part of the General Chapter Dissolution and assesses proper dissolution apparatusperformance.
711 DISSOLUTION
Stage 6 Harmonization 2 〈711〉 Dissolution Official December 1, 2011 Figure 1. Basket Stirring Element 2S (USP34) of 25±2 mm between the bottom of the blade and theinside bottom of the vessel is maintained during the test. FDA REGULATED CANNABIS A perfect storm is an event in which a rare combination of circumstances drastically intensifies the event Cannabis sativa L. •Evolving state laws
CYANOCOBALAMIN (CRYSTALLINE) (2 X 150 MG) Purchase Cyanocobalamin RS (crystalline) (Vitamin B12) Reference Standard, (2 x 150 mg), USP-1152011, CAS No. -68-19-9. Has no added substances & is not a 1% mixture in mannitol. Use in USP-NF dietary supplement tests & assays., Order direct for USP service & support. 85 BACTERIAL ENDOTOXINS CHANGE TO READ: TEST … Stage 6 Harmonization Official December 1, 2012 〈85〉 Bacterial Endotoxins Test1 〈85〉 BACTERIAL ENDOTOXINS Change to read: TEST PREPARATION OF SOLUTIONS Standard Endotoxin Stock Solution—A Standard Endo- toxin Stock Solution is prepared from a USP Endotoxin Refer- Change to read: ence Standard that has been calibrated to the current WHO International Standard for Endotoxin. SODIUM METABISULFITE (2 X 500 MG) Catalog # 1614396: Current Lot R043N0: Previous Lot F1L076 (Valid Use Date: 31-AUG-2017) SDS View: USP Certificate for Current Lot200 YEARS OF
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USP volunteers help shape the future of drug manufacturing Consistent quality. Greater access. They’re what patients deserve and what USP strives to ensure across the globe through the development of public quality standards.Read more
A new generation of tools and standards for biologic medicine quality USP standards have evolved to accommodate medicines of all types. The biosimilar paradigm may ultimately resemble that of generic drugs.Read more
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A new generation of tools and standards for biologic medicine quality USP standards have evolved to accommodate medicines of all types. The biosimilar paradigm may ultimately resemble that of generic drugs.Read more
Novel Excipients: New Hope for Therapeutic Innovations With significant innovations in pharmaceuticals, including biologic drugs and treatments for rare diseases, the need for new and better functioning excipients to improve drug delivery is growing.Read more
A new generation of tools and standards for biologic medicine quality USP standards have evolved to accommodate medicines of all types. The biosimilar paradigm may ultimately resemble that of generic drugs.Read more
Novel Excipients: New Hope for Therapeutic Innovations With significant innovations in pharmaceuticals, including biologic drugs and treatments for rare diseases, the need for new and better functioning excipients to improve drug delivery is growing.Read more
USP volunteers help shape the future of drug manufacturing Consistent quality. Greater access. They’re what patients deserve and what USP strives to ensure across the globe through the development of public quality standards.Read more
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