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USP BIOLOGICS™

USP Biologics is prioritizing the ongoing development of state-of-the-art
analytical tools, standards and solutions to support regulatory predictability,
allowing manufacturers to operate with a high level of confidence and certainty
throughout the drug development and approval process across a variety of
modalities.




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IMPURITIES

Impurities pose risks to manufacturers, regulators and public health. USP can
help.




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NOVEL EXCIPIENTS

USP is supporting the development of novel excipients.




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COMPLEX GENERICS

Generic medicines are essential to improving patient access to important drug
therapies.




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DRUG SHORTAGES

Solving drug shortages: A call to action




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FEATURED SOLUTIONS

Learn about USP’s portfolio of solutions to help address quality assurance,
enhance regulatory predictability, and help manufacturers distribute quality
medicines, dietary supplements and foods.

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PHARMACEUTICAL ANALYTICAL IMPURITIES

To protect patients, the FDA and other global regulatory agencies have issued
public health alerts and guidance documents for manufacturers to assess and
control the presence of nitrosamine impurities in medicines.

Get more information


USP OFFICIAL REFERENCE STANDARDS

USP offers over 7,000 USP Reference Standards, highly characterized physical
specimens of drug substances, excipients, food ingredients, impurities,
degradation products, dietary supplements, compendial reagents, and performance
calibrators. 

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MEDICINE SUPPLY MAP

USP’s Medicine Supply Map (MSM) is a graph-based predictive data model that
generates insights into the upstream medicine supply chain. Using machine
learning and advanced analytics, MSM identifies, characterizes, and quantifies
factors linked to supply chain disruptions for drug ingredients and finished
drug products. 

Learn more


PHARMACEUTICAL ANALYTICAL IMPURITIES

To protect patients, the FDA and other global regulatory agencies have issued
public health alerts and guidance documents for manufacturers to assess and
control the presence of nitrosamine impurities in medicines.

Get more information


USP OFFICIAL REFERENCE STANDARDS

USP offers over 7,000 USP Reference Standards, highly characterized physical
specimens of drug substances, excipients, food ingredients, impurities,
degradation products, dietary supplements, compendial reagents, and performance
calibrators. 

Search and buy


MEDICINE SUPPLY MAP

USP’s Medicine Supply Map (MSM) is a graph-based predictive data model that
generates insights into the upstream medicine supply chain. Using machine
learning and advanced analytics, MSM identifies, characterizes, and quantifies
factors linked to supply chain disruptions for drug ingredients and finished
drug products. 

Learn more


PHARMACEUTICAL ANALYTICAL IMPURITIES

To protect patients, the FDA and other global regulatory agencies have issued
public health alerts and guidance documents for manufacturers to assess and
control the presence of nitrosamine impurities in medicines.

Get more information

Next

build trust in medicines

 

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SOCIAL MEDIA

 * Linked In
 * Twitter
 * Facebook
 * You Tube
 * QualityMatters Blog


SOCIAL MEDIA 3

 * Linked In
 * Twitter
 * Facebook
 * You Tube
 * QualityMatters Blog

 * About
   
   
   ABOUT USP
   
    * About USP
    * Leadership
    * USP Convention
    * USP Volunteers
    * Careers
    * Legal Recognition
    * Newsroom
    * Two Hundred Years of Building Trust
    * Annual Report

 * Our Impact
   
   
   OUR IMPACT
   
    * Complex Generics
    * Medicines Supply Chain
    * Impurities
    * Healthcare Quality & Safety Standards
    * Global Public Health
    * Public Policy
    * Harmonized Standards

 * Our Work
   
   
   OUR WORK OVERVIEW
   
    * Biologics
    * Compounding Standards
    * Dietary Supplements & Herbal Medicines
    * Excipients
    * Federal Government Practice
    * Food Safety & Integrity
    * Reference Standards
    * Small Molecules

 * Products & Solutions
   
   
   PRODUCTS & SOLUTIONS OVERVIEW
   
    * All Products
      * New Products
      * New Lots
      * Coming Soon
    * Biologics
      * Antibiotics
      * Carbohydrates
      * Cell, Gene & Tissues
      * Heparins
      * Monoclonal Antibodies
      * Oligonucleotides
      * Peptides
      * Proteins
      * Vaccines
      * Training Courses
      * Coming Soon
    * Dietary Supplements & Herbal Medicines
      * Amino Acids
      * Botanicals-Herbal Medicines
      * Cannabis
      * Minerals
      * Others-Dietary Supplements
      * Vitamins
      * Training Courses
      * Coming Soon
      * Dietary Supplements Compendia (DSC)
      * Herbal Medicines Compendia (HMC)
    * Dissolution
    * Excipients
      * Binders & Fillers
      * Buffers & pH Modifiers
      * Chelating Agents
      * Coatings
      * Diluents
      * Disintegrants
      * Dual Active
      * Emollients & Ointments
      * Flavor & Coloring Agents
      * Glidants & Lubricants
      * Impurity
      * Preservatives
      * Solvents
      * Surfactants
      * Training Courses
    * Foods
      * Adulterants
      * Amino Acids
      * Carbohydrates
      * Colors
      * Fats & Oils
      * Flavors & Fragrances
      * Functional Ingredients
      * Infant Formula Ingredients
      * Matrix Based Materials
      * Preservatives
      * Proteins & Amino Acids
      * Proteins & Amino Acids
      * Sweeteners
      * Training Courses
      * FCC Analytical Materials
      * Food Chemical Codex (FCC)
    * Impurities
      * Reference Standards
      * Pharmaceutical Analytical Impurities (PAIs)
      * Nitrosamines
    * Small Molecules
      * Associated Drug Substances
      * Impurities
      * System Suitability
      * Training Courses
      * Coming Soon
    * Authorized Distributors
    * Advanced Manufacturing
      * Continuous Manufacturing Knowledge Center
      * R&D Analytical Solutions
      * Pharmaceutical Continuous Manufacturing: USP Technical Guide
    * Verification Services
      * Dietary Supplement Verification Program
      * Ingredient Verification Services
      * GMP Audit Program
      * Program Participants
    * Quality Solutions Sheets
    * Pharmatech Associates
    * USP-NF
    * Compendial Tools
    * USP-ID, Delivered by Mestrelab Research
    * Newsletters & Updates

 * Events & Training
   
   
   EVENTS & TRAINING
   
    * Search Events and Training
    * USP Education, Courses & Webinars
    * Workshops
    * Expert Body Meetings
    * Open/Stakeholder Forums
    * User Forums

 * Get Involved
   
   
   GET INVOLVED OVERVIEW
   
    * Partner
    * Provide Input
    * Review Work Plans
    * Volunteer
    * Observe a Committee Meeting
    * Open/Stakeholder Forums

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