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R&D ANALYTICAL SOLUTIONS

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R&D ANALYTICAL SOLUTIONS




ADVANCING PHARMACEUTICAL DEVELOPMENT AND MANUFACTURING

The scientific rigor behind the quality standards trusted by manufacturers and
regulators around the globe – now available through USP’s R&D Analytical
Solutions. New manufacturing technologies and increasingly complex drug
formulations pose challenges for manufacturers and pharmaceutical companies to
bring products to market.

 

 







Supporting you with in-lab analytical & process development by: 






Solving challenging problems






Driving innovation






Containing costs and building efficiencies






We offer tailored and quality-focused solutions for your unique needs through:






Rigorous scientific expertise






Dedication to quality






Adherence to best practices







SERVICES LEVERAGING STATE-OF-THE-ART LABORATORIES AND EXTENSIVE SCIENTIFIC
EXPERTISE

> Method development and qualification
> 
> Materials characterization
> 
> Techniques
> 
> Case studies

> Examples of method development and qualification work: identification, assays,
> stability indiciating, impurities, cleaning
> Method development and qualification cover evaluation and screening,
> development and optimization, robustness/forced degradation, validation, and
> report

> Purity analysis: elemental composition, description/appearance, water content,
> chromatographic purity, potential mutagenic impurities, residual solvents,
> residual metals, resiude on ignition
> Isolation and identification: chromatographic isolation and sample treatment,
> identification (IR, NMR, MS)
> Advanced characterization, including structural characterization and unknowns:
> qNMR, purity, coutner-ion, elemental analysis, vapor sorption, differential
> scanning calorimetry, chiral purity, optical rotation

> Chromatography: GC, HPLC (PDA, fluorescence, refractive index, CAD, MALs,
> ELSD), prep HPLC, fraction collector, GCMS, LCMS, hi res LCMS (triple
> quadrupole, qToF, Maldi, single quadrupole, Orbitrap)
> Spectroscopy and PAT: FTIR, Raman, and n-IF, UV-Vis, NMR (high field,
> benchtop)
> Other: ICPMS, IC, oven, stability chamber (heat, humidity, light), KF, pH
> meter, centrifuge, advanced software packages, (e.g. QbD predictive
> degradation modeling software, and statistical)

>  * Low level nitrosamine impurity quantification
>  * Stability-indicating method development and validation by GC-FID
>  * Survey of peptide quantification methods and comparison of their
>    reproducibility 
>  * Degradation pahtyway investigation, and identification and structural
>    characterization of a degradation product







CONTACT US

For more information about USP’s R&D Analytical Solutions complete the form
below.









RELATED PRODUCTS AND SERVICES

 * Continuous Manufacturing Knowledge Center
 * Nitrosamine Impurities
 * Pharmaceutical Analytical Impurities 
 * Pharmatech Associates, a USP Company
 * USP Education, Courses, and Webinars
 * USP-ID a qNMR Software Solution
 * USP-NF
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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
      * Critical Reagents
      * Heparins
      * Microbiology
      * Monoclonal Antibodies
      * Oligonucleotides
      * Peptides
      * Proteins
      * Raw Materials
      * 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
    * 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
      * New or Revised Standards
      * Reference Standards
      * Compounding Monographs
      * Submission Guidelines
      * Donor Recognition
    * Volunteer
      * How to Become a Volunteer
      * View Volunteer Opportunities
    * Provide Input
      * Comment on Proposed Standards
      * Review Work Plans
      * Observe a Committee Meeting
      * Open/Stakeholder Forums

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