Update to USP <621> Chromatography: What does this mean? USP 37 NF 32 1S Current as of August 2014
|
|
- Stephen Carr
- 6 years ago
- Views:
Transcription
1 Update to USP <621> Chromatography: What does this mean? USP 37 NF 32 1S Current as of August Waters Corporation 1
2 What is the USP-NF? The United States Pharmacopeia National Formulary (USP-NF) is a book of pharmacopeial standards Drugs substances & preparations monographs: USP Dietary supplements & ingredients monographs: USP Excipient monographs: NF More than 4500 monographs The USP-NF is the official authority FDA-enforceable standards Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere USP has no role in enforcement The U.S. Federal Food, Drug, and Cosmetics Act designates the USP NF as the official compendia for drugs marketed in the United States 2015 Waters Corporation 2
3 Why is Chromatography <621> Important? Question From CURRENT USP-NF Online FAQs1 Q. How much can I modify a chromatographic procedure and still be in compliance? Can column length, internal diameter, mobile phase composition be modified? A. Chromatography <621> contains a list of allowed adjustments to chromatographic systems. However, the user should verify the suitability of the method under the new conditions by assessing the relevant analytical performance characteristics potentially affected by the change (see section System Suitability under Chromatography <621>) Waters Corporation 3
4 USP <621> Chromatography Defines Allowable adjustments Adjustments to a USP method may be made to meet system suitability requirements Verification tests must be performed after changes Full re-validation not required Must use the same L-designation of column Isocratic hold or dwell volume adjustments are allowed USP 37 NF 32 S1 - to be official Aug. 1, significant changes to Chapter <621> Chromatography 2015 Waters Corporation 4
5 Current Changes to <621> Allowable Adjustments in USP <621> Chromatography Variable Previous (USP36-NF31) Since Aug 1, 2014 (USP37-NF32 S1) Isocratic & Gradient Isocratic Gradient Particle Size -50% per constant L/dp or N: -25% to +50% Column Length ±70% no changes allowed Flow Rate ±50% *based on particle size and ±50% no changes allowed Column ID Any allowed Any allowed no changes allowed Injection Volume Any reduction Any allowed Any allowed Column Temperature ±10 C ±10 C ±10 C Mobile Phase ph ±0.2 unit ±0.2 unit ±0.2 unit Flow rate (isocratic): F 2 = F 1 x [(dc 2 2 x dp 1 )/(dc 1 2 x dp 2 )] L/dp = column length (L) to particle size (dp) ratio N = theoretical plate count (for solid-core particles) 2015 Waters Corporation 5
6 USP and EP Variable USP <621> Guidelines as of Aug 1, 2014 (USP37-NF32 S1) Current EP <2.2.46> V8.2 Guidelines Isocratic Gradient Isocratic Gradient Particle Size -50%, no increase No changes allowed Per constant L/dp or N: -25% No changes allowed to +50% Column Length ±70% ±70% Flow Rate *Based on particle size and ±50% No changes allowed ±50%, *More if changing column dimensions *Flexible ONLY if changing column dimensions Column ID Flexible No changes allowed ±25% ±25% Injection Volume Flexible Flexible Decrease only for proper detection and repeatability Decrease only for proper detection and repeatability Column Temperature ±10 C ±10 C ±10 C ±5 C Mobile Phase ph ±0.2 unit ±0.2 unit ±0.2 unit No changes allowed *F 2 =F 1 x [(dc 2 2 x dp 1 )/(dc 1 2 x dp 2 )] *F 2 =F 1 x [(L 2 x d 2 2 )/(L 1 x d 1 2 )] L/dp = column length (L) to particle size (dp) ratio N = theoretical plate count (for solid-core particles) Refer to Chapter <621> of USP37- NF32 S1 for further information and details on adjustments not shown L= Column Length d= Column ID Refer to Section <2.2.46> of EP version 8.2 for further information and details on adjustments not shown 2015 Waters Corporation 6
7 Benefits: Isocratic USP Method Levonorgestrel/Ethinyl Estradiol HPLC HPLC AU USP XBridge Res: 6.9 C Minutes UPLC ethinyl estradiol levonorgestrel Alliance 2695 HPLC Column: XBridge C 8, 4.6 x 150mm, 5µ (L7) L/dp = 30,000 Flow Rate: 1.0 ml/min, pressure 1400 psi Mobile Phase: 35:15:45 ACN:MeOH:Water Injection Volume: 50 µl AU USP Res: 7.0 ethinyl estradiol levonorgestrel ACQUITY UPLC H-Class Column: ACQUITY BEH C 8, 2.1 x 50mm, 1.7µ (L7) L/dp = 29,400 Flow Rate: 0.61 ml/min, pressure 7700 psi Mobile Phase: 35:15:45 ACN:MeOH:Water Injection Volume: 3.5 µl Minutes Changes made within USP <621> allowable adjustments (USP37-NF32 S1, August 2014) 90% savings in runtime and 94% solvent savings per run! Re-validation not required 2015 Waters Corporation 10
8 Benefits: USP Gradient Method Galantamine and Related compounds HPLC to UPLC Transfer: HPLC Separation on Alliance HPLC System Reduce analysis time by 77% (4.3X) while preserving separation integrity Galantamine XBridge TM C x 100 mm, 3.5 µm Tailing = 1.60 Rs = 7.6 Tailing and Resolution Criteria were met Assay Criteria: UPLC Separation on ACQUITY UPLC H-Class USP Tailing < 2.0 Rs (galantamine/impurity 4) > 4.5 AU Galantamine ACQUITY UPLC BEH C x 50 mm, 1.7 µm Tailing = 1.43 Rs = 7.2 Re-validation will be required under USP37-NF32 S1 (effective Aug 2014) Waters Corporation 11
9 Empower Method Validation Manager for Verification/Validation Improve compliance and reduce errors: Automate testing within Empower 2015 Waters Corporation 12
10 Reference Experts from USP37-NF32 1S (Published) 2015 Waters Corporation 14
11 Allowable adjustments 2015 Waters Corporation 15
12 Changes to Particle Size 2015 Waters Corporation 16
13 Changes to Flow Rate 2015 Waters Corporation 17
14 Changes to Other factors 2015 Waters Corporation 18
15 Example provided 2015 Waters Corporation 19
FUTURE-PROOF SOLUTIONS FOR REGULATED LABORATORIES IN THE FACE OF CHANGING USP <621> GUIDELINES
FUTURE-PROOF SOLUTIONS FOR REGULATED LABORATORIES IN THE FACE OF CHANGING USP GUIDELINES How to use UPLC technology within allowable adjustments to improve QC laboratory throughput For many in the
More information9/2/2014. USP Monograph Modernization. Todays topics. USP basic. Todays topics. - USP basic. - USP publications. - USP monograph modernization
USP Monograph Modernization Procedure Review and Development Donald Min 2 USP basic Since USP's founding in 1820, our operations have grown exponentially: from 11 volunteers collaborating from their respective
More informationOverview of USP Activities and How to Get Involved
Overview of USP Activities and How to Get Involved Ravi Ravichandran, Ph.D. Principal Scientific Liaison, Chemical Medicines United States Pharmacopeia Outline Introduction to the USP USP Standard Setting
More informationACQUITY Arc TM System
ACQUITY Arc TM System Introducing the Newest Member of the Waters LC Portfolio 2015 Waters Corporation 1 Adopting Modern LC Technology in a Global Economy Highly competitive, regulated business environment
More informationSimplifying Methods Transfer: Novel Tools for Replicating Your Established Methods on an ACQUITY Arc System
Simplifying Methods Transfer: Novel Tools for Replicating Your Established Methods on an ACQUITY Arc System Paula Hong, Richard Andrews, Peyton C. Beals, and Patricia R. McConville Waters Corporation,
More informationHPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools
HPLC to UPLC Method Migration: An Overview of Key Considerations and Available Tools Dr. Michael Swartz, Ph. D. Principal Consulting Scientist Worldwide Pharmaceutical Business Operations Waters Corporation
More informationACQUITY Arc VERSATILITY WITHOUT COMPROMISE
ACQUITY Arc VERSATILITY WITHOUT COMPROMISE BUILT UPON A FOUNDATION OF RELIABILITY With the ACQUITY Arc System, analytical scientists can experience true plug-and-play method compatibility for HPLC and
More informationOriginal Paper. The role of UHPLC in pharmaceutical development. i 2007 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. 1 Introduction
J. Sep. Sci. 2007, 30 S. M. Chesnut et al. Stephen M. Chesnut John J. Salisbury Analytical Research and Development, Pfizer Global Research and Development, Groton/New London Laboratories, Groton, CT,
More informationA Comparison of Compendia Normal Phase LC Methods Run Under Supercritical Fluid Chromatography Conditions
A Comparison of Compendia Normal Phase LC Methods Run Under Supercritical Fluid Chromatography Conditions Stéphane Dubant Waters ESAC April 5th 2011 2011 Waters Corporation 1 Agenda Introduction and Benefits
More informationApplication Note. Author. Abstract. Pharmaceuticals. Detlef Wilhelm ANATOX GmbH & Co. KG. Fuerstenwalde, Germany mau
Development, validation, and comparison of an HPLC method to analyze paracetamol and related impurities according to the European Pharmacopoeia (EP) and USP using the Agilent 1120 Compact LC and the Agilent
More informationThank You to United States Pharmacopeia for Their Sponsorship and Assistance
Use of Measurement Uncertainty in Testing a Drug Substance M.L. Jane Weitzel Quality Analysis Consultants mljweitzel@msn.com Eurachem/CITAC Workshop June 2011 Thank You to United States Pharmacopeia for
More informationRole of USP Monographs and. General Chapters. Steve Zigler, Ph.D.
Role of USP Monographs and General Chapters Steve Zigler, Ph.D. Siemens PETNET Solutions USP Disclosure I have served as a USP volunteer in the area of PET drugs for 15 years Member of various Expert Committees
More informationQuality of raw materials and manufacturing of advanced therapies. Fouad Atouf, Ph.D. Head, Global Biologics July 12, 2018
Quality of raw materials and manufacturing of advanced therapies Fouad Atouf, Ph.D. Head, Global Biologics July 12, 2018 Evolution of the compendia 1820: a single recipe book 2018: Procedures and acceptance
More informationQuality-by-Design-Based Method Development Using an Agilent 1290 Infinity II LC
Quality-by-Design-Based Method Development Using an Agilent 129 Infinity II LC An Efficient Method Development Workflow Combined with ISET-mediated Method Transfer Under Waters Empower 3 CDS Control Application
More informationAnalytical Instrument Qualification According to USP <1058>: Requirements and Examples for the Agilent 1290 Infinity LC System
Analytical Instrument Qualification According to USP : Requirements and Examples for the Agilent 1290 Infinity LC System 1) USP : Scope, approach, requirements 2) Qualification Examples for
More informationSFC Säulen für analytische und preparative Anwendungen
SFC Säulen für analytische und preparative Anwendungen Technology Symposium Vienna, 25 th October 2016 DI Verena Schmid 2016 Waters Corporation 1 CHIRAL SEPARATIONS ACQUITY UPC 2 Trefoil 2016 Waters Corporation
More informationSimple Techniques for Improving the Isolation of Synthetic Peptides Jo-Ann Jablonski Principal Scientist Waters Corporation
Simple Techniques for Improving the Isolation of Synthetic Peptides Jo-Ann Jablonski Principal Scientist Waters Corporation 2016 Waters Corporation 1 Agenda Background Techniques Scaling a separation Focusing
More informationOnline UPLC Method for the Support of Cleaning Validation and the Routine Monitoring of Cleaning Procedures
Online UPLC Method for the Support of Cleaning Validation and the Routine Monitoring of Cleaning Procedures Tanya Tollifson Waters Corporation, Milford, MA, USA APPLICATION BENEFITS Online cleaning wash
More informationá1225ñ VALIDATION OF COMPENDIAL PROCEDURES
1640 á1224ñ Transfer of Analytical Procedures / General Information USP 39 THE ANALYTICAL PROCEDURE The procedure should be written with sufficient detail and explicit instructions, so that a trained analyst
More informationAPPLICATIONS TN Overview of Kinetex 2.6 µm Core-Shell Technology
TN-7 Determination of Impurities and Related Substances for Glibenclamide (EP Monograph 78). Increased Sensitivity, Improved Resolution and Faster Analysis Using Kinetex.6 µm Core-Shell LC Columns Elli
More informationAnalytical Methods Development and Validation
Understanding and Implementing Efficient Analytical Methods Development and Validation Jay Breaux, Kevin Jones, and Pierre Boulas Analytical methods development and validation play important roles in the
More informationMethod Development Considerations for Reversed-Phase Protein Separations
Method Development Considerations for Reversed-Phase Protein Separations Hillary B. Hewitson, Thomas E. Wheat, Paula Hong, Kenneth J. Fountain APPLICATION BENEFITS n The BEH00 C 4 chemistry is available
More informationAnalytical Method Transfer Program. Richard B. Nguyen. Associate Scientific Liaison, Chemical Medicines, USP
Analytical Method Transfer Program Richard B. Nguyen. Associate Scientific Liaison, Chemical Medicines, USP Outline Requirements for an AMT Program Develop Your AMT Program Qualify Your AMT Program On-going
More informationCHAPTERS 1, 2 and 3 CHAPTER-4 CHAPTER-5,
319 Presently in the pharmaceutical industry, drug analysis plays a vital role in deciding the quality and potency of the drug. The selection of analytical method used to quantify the drugs and impurities
More informationA Brief Overview of HPLC & UHPLC Method Development and Optimization. Dr. Chris Message UHPLC/HPLC Product Specialist Phenomenex
A Brief Overview of HPLC & UHPLC Method Development and Optimization Dr. Chris Message UHPLC/HPLC Product Specialist Phenomenex Poll Question 1 What learning objectives most attracted you to this webinar?
More informationValidation/Verification of Test Methods An FDA Perspective. Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness
Validation/Verification of Test Methods An FDA Perspective Laure H. Kairawicz, Ph.D. Senior Scientist Expert Witness FD & C Act Overview Definition of drugs What cgmps are Finished Pharmaceuticals cgmp
More informationAPPLICATIONS TN Overview of Kinetex 2.6 µm Core-Shell Technology
Determination of Impurities and Related Substances for (Ph. Eur. Monograph 8): Increased Sensitivity, Improved Resolution and Faster Analysis Using Kinetex.6 µm Core-Shell LC Columns Ellie Abbasi, Jeff
More informationSTIMULI TO THE REVISION PROCESS
Page 1 of 6 STIMULI TO THE REVISION PROCESS Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts USP's Nomenclature Initiatives Angela G. Long, M.S.; Andrzej
More informationSEC/CEX - separation of biomolecules: High-throughput screening (HTS) and data analysis via platform methods
SEC/CEX - separation of biomolecules: High-throughput screening (HTS) and data analysis via platform methods Kerstin Appenzeller Kathrin Schäker-Theobald, PhD 20. Juni 2018 1 Disclosure Kerstin Appenzeller
More informationCommentary Pharmacopeial Forum 35(5) Sept.-Oct Interim Revision Announcements to USP 33-NF 28 Reissue
Commentary Pharmacopeial Forum 35(5) Sept.-Oct. 2009 Interim Revision Announcements to USP 33-NF 28 Reissue In accordance with USP s Rules and Procedures of the Council of Experts, USP publishes all proposed
More information[ ACQUITY UPLC system ] Performance so strong it moved the industry forward
[ ACQUITY UPLC system ] ULTRA PERFORMANCE Performance so strong it moved the industry forward And brought the impact of science beyond the bench The proven performance of the ACQUITY UPLC System, used
More informationProposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding <823>
Proposed Revision of USP General Chapter Radiopharmaceuticals for Positron Emission Tomography Compounding Ravi Ravichandran, Ph.D. Steve Zigler, Ph.D. February 21, 2011 Agenda Rationale for the
More informationCHAPTER-3. Zolmitriptan
45 CHAPTER-3 Zolmitriptan 46 CHAPTER-3 Chapter-3 : Zolmitriptan S. No. Name of the Sub- Title Page No. 3.1 Introduction 47-49 3.2 Experimental 49-59 3.3 Method validation 59-62 3.4 Result& Discussion 62-78
More informationLatest USP Initiatives: Monographs, General Chapters, and Compounding
Latest USP Initiatives: Monographs, General Chapters, and Compounding Jim Ponto, MS, RPh, BCNP Disclosures Volunteer member on several USP Expert Committees and Expert Panels associated with radiopharmaceutical
More informationBRIEFING. . Over time, 466 may be used less frequently and may be withdrawn.
Page 1 of 13 BRIEFING 1086 USP 37 page 828. As part of an ongoing monograph modernization initiative, the United States Pharmacopeial Convention (USP) is updating this general chapter, 1086 Impurities
More informationMass Detection for the Chromatographer Waters ACQUITY QDa Detector
Mass Detection for the Chromatographer Waters ACQUITY QDa Detector Warren B Potts III Senior Director Americas Marketing warren_potts@waters.com 2017 Waters Corporation 1 Agenda Overview of technology
More informationDeveloping Quantitative UPLC Assays with UV
Developing Quantitative UPLC Assays with UV Detection for Antibodies & Other Proteins Steve Taylor 2011 Waters Corporation 1 Outline UPLC technology for RP protein separations Method development parameters
More information[ ACQUITY UPLC SYSTEM ] Performance so strong it moved the industry forward
ULTRA PERFORMANCE Performance so strong it moved the industry forward And brought the impact of science beyond the bench The proven performance of the ACQUITY UPLC System, used in thousands of laboratories
More informationDeveloping an Analytical Impurity Control Strategy Using QbD. Mark D. Argentine
Developing an Analytical Impurity Control Strategy Using QbD Mark D. Argentine Quality by Design in Development Relies upon developing knowledge around processes and products Ref: M. Nasr, 2006 for effective
More informationTechniques for Improving the Efficiency of Large Volume Loading in Preparative Liquid Chromatography
Techniques for Improving the Efficiency of Large Volume Loading in Preparative Liquid Chromatography Jo-Ann M. Jablonski, Andrew J. Aubin, and Wendy Harrop Waters Corporation, Milford, MA, USA APPLICATION
More informationQuantification of genotoxic "Impurity D" in Atenolol by LC/ESI/MS/MS with Agilent 1200 Series RRLC and 6410B Triple Quadrupole LC/MS
Quantification of genotoxic "Impurity D" in Atenolol by LC/ESI/MS/MS with Agilent 12 Series RRLC and 641B Triple Quadrupole LC/MS Application Note Manufacturing Process Development Author Siji Joseph Agilent
More informationAnalysis of biomolecules by SEC and Ion-Exchange UPLC
Analysis of biomolecules by SEC and Ion-Exchange UPLC Anders Feldthus, Waters Nordic 2011 Waters Corporation 1 Waters Commitment To develop, commercialize and market columns that when used on Waters ACQUITY
More informationScale-up with the Agilent SD-1 Purification System analytical and preparative runs on a single system
Scale-up with the Agilent SD-1 Purification System analytical and preparative runs on a single system Technical Overview Author Absorbance Monitored wavelength: 230 nm Methylparaben Ethylparaben 9.717
More informationWhy Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services
Why Do I Test, What Do I Test & When Do I Test It? Ross Caputo, PhD Chief Technical Officer Eagle Analytical Services Disclosures I, Ross Caputo, declare no conflicts of interest, real or apparent, and
More informationApplication Note. Author. Abstract. Pharmaceuticals. A.G.Huesgen Agilent Technologies, Inc. Waldbronn, Germany
Seamless instrument to instrument method transfer of an USP/EP method from an Agilent 1220 Infinity LC to an Agilent 1290 Infinity Binary LC using Intelligent System Emulation Technology (ISET) Application
More informationAnalytical Procedures and Methods Validation for Drugs and Biologics
Final Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics Analytical procedures and Method Validation June 21, 2016 Lokesh Bhattacharyya Chief, LACBRP/DBSQC OCBQ/CBER/FDA
More informationReference Standard Characterization. Steve Lane. General Manager, NSF Reference Standards.
Reference Standard Characterization Steve Lane General Manager, NSF Reference Standards www.nsf-rs.org Regulatory Bodies will require that an Excipient: Be safe in the amount or dose used Meet applicable
More information[ APPLICATION NOTE ] Developing Analytical Chromatographic Methods for Pharmaceutical Stability Investigations APPLICATION BENEFITS INTRODUCTION
Developing Analytical Chromatographic Methods for Pharmaceutical Stability Investigations Thomas Swann Waters Corporation, Milford, MA, USA APPLICATION BENEFITS Understand factors, responses, response
More informationMartin Gilar Waters Corporation, Milford, MA, U.S. Origins of synthetic oligonucleotides impurities. Lab-scale isolation options
LIGNUCLETIDE SEPARATIN TECHNLGY: SYNTHESIS CHALLENGES AND HPLC ISLATIN PTINS Martin Gilar Waters Corporation, Milford, MA, U.S. INTRDUCTIN rigins of synthetic oligonucleotides impurities Use of synthetic
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 ANAB Cert# AR-1470 ISO/IEC 17025 ANAB Cert# AT-1467 OMEPRAZOLE CERTIFIED REFERENCE MATERIAL CERTIFIED PURITY: 99.2 %, U crm = ±0.1 % k = 2 (Mass Balance/as is basis)
More informationDrug Metabolism and Disposition. Supplement Materials
Drug Metabolism and Disposition Supplement Materials Inhibition of P-glycoprotein leads to improved oral bioavailability of Compound K, an anti-cancer metabolite of red ginseng extract produced by gut
More informationPatricia McConville Manager Product Positioning Laboratory. Next Generation Instrument Design
Patricia McConville Manager Product Positioning Laboratory Next Generation Instrument Design Patricia McConville Manager Product Positioning Laboratory 2005 Waters Corporation Next Generation Instrument
More informationHigh Throughput Methods for the Identity Tests of Low Molecular Mass Heparins and Heparin Sodium
High Throughput Methods for the Identity Tests of Low Molecular Mass Heparins and Heparin Sodium Transfer of Pharmacopoeial GPC/SEC Analytical Methods to UHPLC Technology F. Spelta, L. Liverani, A. Peluso
More informationInertsil ODS-3 2 µm. Base Silica Physical Properties and Chemical Modification. Base Silica: High Purity Silica Gel % Surface Area: 450 m 2 /g
0 High-Speed Separation Inertsil ODS-3 2 µm Base Silica Physical Properties and Chemical Modification Base Silica: High Purity Silica Gel 99.999% Surface Area: 450 m 2 /g Pore Size: 100 Å Pore Volume:
More informationMaximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns
Maximizing Chromatographic Resolution of Peptide Maps using UPLC with Tandem Columns Hongwei Xie, Martin Gilar, and Jeff Mazzeo Waters Corporation, Milford, MA U.S. APPLICATION BENEFITS The ACQUITY UPLC
More informationExtending Beyond Use Dating for Compounded Preparations Webinar Q&A
Stability Studies 1. If potency over time studies are not acceptable to extend BUD, then why is it offered? Potency point-in-time studies only indicate the potency of a compounded preparation at that specific
More informationEffect of Peak Symmetry Analytical Figures of Merit Used in Pharmaceutical Validation
Effect of Peak Symmetry Analytical Figures of Merit Used in Pharmaceutical Assay Validation _, M. Capparella, Z. El Fallah and U. D. Neue Waters Corporation, 34 Maple St. Milford, MA 01757 Abstract Pharmaceutical
More information10. Validated Normal Phase HPLC Method for the Determination. Fulvestrant is primarily used in the treatment of hormone receptor
229 10. Validated Normal Phase HPLC Method for the Determination of Fulvestrant in Pharmaceutical Dosage Forms 10.1 Introduction Fulvestrant is primarily used in the treatment of hormone receptor positive
More informationExtending Beyond Use Dating for Compounded Preparations Webinar Q&A
Stability Studies 1. If potency over time studies are not acceptable to extend BUD, then why is it offered? Potency point-in-time studies only indicate the potency of a compounded preparation at that specific
More informationFood Ingredients Stakeholder Forum Meeting #1 for the Cycle December 3, Discussion and Recommendations
Food Ingredients Stakeholder Forum Meeting #1 for the 2010-2015 Cycle December 3, 2010 Discussion and Recommendations Harmonization of Food Ingredients Discussion Issues for food ingredients arise in customs
More informationRole of Industry in USP Monograph Modernization. ExcipientFest Americas 2015 APRIL 29, Agenda
Role of Industry in USP Monograph Modernization ExcipientFest Americas 2015 APRIL 29, 2015 John S. Punzi, Ph.D. 1 Agenda Impact of OTC s + Complexity Monograph Modernization Industry Approaches Acetaminophen
More informationUltrapure water: LC-MS suitability tests
Ultrapure water: LC-MS suitability tests Application details Contaminations such as ions and organic traces present in ultrapure water affect LC- MS analyses and decrease perfomance of the analytical instumentation.
More informationGUIDANCE NOTES ON ANALYTICAL METHOD VALIDATION
ON ANALYTICAL METHOD VALIDATION HSA September 2004 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided the source is acknowledged. MQA Dir: DISK1\GUIDE-MQA-012A-004.doc
More informationMethod Translation in Liquid Chromatography
Method Translation in Liquid Chromatography Technical Overview Abstract Ronald E. Majors Agilent Technologies, Inc. 2850 Centerville Rd Wilmington, DE 19808 USA With the recent emphasis on high performance
More informationSTANDARD OPERATING PROCEDURES. Handling and working with Analytical Standards
Page: 1 of 6 1.Purpose The purpose of this Standard Operating Procedure is to establish a standardized procedure of using United States Pharmacopoeia (USP) standards, detailing the procedure of qualification,
More informationSecundum Artem. USP Chapter <795> Pharmaceutical Compounding - Nonsterile Preparations INTRODUCTION BACKGROUND VOLUME 13 NUMBER 4
VOLUME 13 NUMBER 4 Secundum Artem Current & Practical Compounding Information for the Pharmacist. USP Chapter Pharmaceutical Compounding - Nonsterile Preparations GOALS AND OBJECTIVES Goal: The goal
More informationUSP Priority Excipient Monograph Modernization Updates
The USP Excipients Stakeholder Forum Meeting # 2 June 18, 2014 USP Priority Excipient Monograph Modernization Updates Catherine Sheehan Senior Director, Excipients United States Pharmacopeial Convention
More informationACQUITY UPLC. I-Class PLUS WHAT SEPARATES YOU FROM EVERYONE ELSE
ACQUITY UPLC I-Class PLUS WHAT SEPARATES YOU FROM EVERYONE ELSE COMPLEX CHALLENGES SOLVED Looking for answers to the most complex scientific challenges is what you do. Your research could lead to ground-breaking
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 ACLASS Cert# AR-1470 ISO/IEC 17025 ACLASS Cert# AT-1467 OMEPRAZOLE CERTIFIED REFERENCE MATERIAL H N O N CH 3 S H 3 CO N OCH 3 CH 3 CERTIFIED PURITY: 99.7%, U crm =
More informationA Simple Rapid and Sensitive Method Development for Quantification of Quetiapine Fumarate in Bulk and Dosage Forms Using RP-HPLC
Human Journals Research Article February 2018 Vol.:11, Issue:3 All rights are reserved by Priyanka Teepoju et al. A Simple Rapid and Sensitive Method Development for Quantification of Quetiapine Fumarate
More informationSize Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column
Size Exclusion Chromatography of Biosimilar and Innovator Insulin Using the Agilent AdvanceBio SEC column Application Note Bio-Pharmaceutical Authors M. Sundaram Palaniswamy and Andrew Coffey Agilent Technologies,
More informationA Fast and Effective Approach for Running EPA Method 539: Determination of Hormones in Drinking Water using SPE and LC/MS/MS
A Fast and Effective Approach for Running EPA Method 539: Determination of Hormones in Drinking Water using SPE and LC/MS/MS Xianrong (Jenny) Wei 1, Matthew Trass 1, Ali Haghani 2, Andy Eaton 2 1 Phenomenex,
More informationA Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts
A Modular Preparative HPLC System for the Isolation of Puerarin from Kudzu Root Extracts Andrew Aubin and Ronan Cleary Waters Corporation, Milford, MA, USA APPLICATIN BENEFITS A modular preparative HPLC
More informationExcipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance
Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance by Tom Savage, NSF International Since 2008, when patient deaths were first linked to
More informationQualification of UPLC system IRequest UPLC Community Tips & tricks Waters Corporation 1
News from service 22.05.2012 Qualification of UPLC system IRequest UPLC Community Tips & tricks 2007 Waters Corporation 1 2007 Waters Corporation 2 System QT What is SystemsQT? Key benefits How is it installed?
More informationFast Preparative Column Liquid Chromatography (PCLC)
Fast Preparative Column Liquid Chromatography (PCLC) Application Note 224 Joan Stevens, Ph.D. and Gary Scharrer Introduction Preparative HPLC is recognized as a prime method for obtaining pure compounds
More information2012 Waters Corporation 1
UPLC User meeeting April 2012 Principles and Practices for SEC, IEX for Intact Protein Analysis by UPLC anders_feldthus@waters.com 2012 Waters Corporation 1 Agenda Ion-Exchange Chromatography Theory and
More informationMethod Development of a 2D LC-HRMS Extraction and Detection Method for Organophosphorus Flame Retardants in Environmental Water Samples
Method Development of a 2D LC-HRMS Extraction and Detection Method for Organophosphorus Flame Retardants in Environmental Water Samples Ken Rosnack 1 Lauren Mullin 1,2, Malorie Mella 1, Claude Mallet 1,
More information[ APPLICATION NOTE ] APPLICATION BENEFITS INTRODUCTION WATERS SOLUTIONS KEYWORDS
Quantitative Method for the Determination of Potentially Mutagenic Impurities of Ondansetron Using UPC 2 Coupled with a Xevo TQ-S micro Jennifer Simeone, Paula Hong, and Patricia R. McConville Waters Corporation,
More informationChallenges And Opportunities In Developing And Modernizing Public Standards For NF Monographs
Excipient Fest Puerto Rico April 28-29, 2015 Challenges And Opportunities In Developing And Modernizing Public Standards For NF Monographs Catherine Sheehan Sr. Director, Excipients United States Pharmacopeial
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 ANAB Cert# AR-1470 ISO/IEC 17025 ANAB Cert# AT-1467 GABAPENTIN CERTIFIED REFERENCE MATERIAL H 2 N COOH CERTIFIED PURITY: 99.9%, U crm = ±0.05% k = 2 (Mass Balance/as
More informationHPLC to UPLC: Method Transfer and Development
Method Transfer From HPLC to UPLC Methods Transfer Considerations Four classes of generic HPLC methods transfer include: Replace a longer column with a shorter column Replace a column brand with another
More informationSample Sizes in Uniformity Measurements The Role of USP
Sample Sizes in Uniformity Measurements The Role of USP Anthony J. DeStefano, Ph.D. Walter W. Hauck, Ph.D. Vice President, General Chapters Sr. Scientific Fellow US Pharmacopeia US Pharmacopeia Part I
More informationQuick Manual to the Waters UPLC System
1 Quick Manual to the Waters UPLC System 1. Application of Chiral HPLC Columns Warning! The HPLC columns are destroyed if the pressure overrides 2000 psi. The highest pressure applied for routine analysis
More informationTHESIS SUBMITTED TO THE ANDHRA UNIVERSITY IN PARTIAL FULFILMENT FOR THE AWARD OF THE DEGREE OF DOCTOR OF PHILOSOPHY IN PHARMACEUTICAL SCIENCES
Synopsis of the Thesis entitled QUANTITATIVE DETERMINATION OF ACTIVE PHARMACEUTICAL INGREDIENTS, RELATED SUBSTANCES AND ORGANIC & POLYMORPHIC IMPURITIES IN PHARMACEUTICAL FORMULATIONS BY LIQUID CHROMATOGRAPHY
More informationSize-Exclusion Chromatography (SEC) Optimization Guide
Size-Exclusion Chromatography (SEC) Optimization Guide 1 Table of Contents I. Introduction II. ACQUITY UPLC Instrumentation Considerations for Successful SEC Analysis III. Importance of Developing a Robust
More informationUsing Empower SystemsQT Qualification Tool
Using Empower SystemsQT Qualification Tool for Waters Modular HPLC Systems A summary of Empower SystemsQT Qualification Tool features and benefits, with emphasis on the technical attributes of the qualification
More informationEmulation of the Agilent 1100 Series LC Through Waters Empower Software Analysis of an Analgesic Mixture
Agilent 129 Infinity II LC with ISET Emulation of the Agilent 11 Series LC Through Waters Empower Software Analysis of an Analgesic Mixture Application Note Small Molecule Pharmaceuticals Author Melanie
More informationThe United States Pharmacopeia Strategy on Biotherapeutic Products Standards. Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts
The United States Pharmacopeia Strategy on Biotherapeutic Products Standards Jaap Venema, Ph.D. Chief Science Officer & Chair, Council of Experts U.S. Pharmacopeia Who We Are Scientific, independent, volunteer-driven,
More informationSean M. McCarthy and Martin Gilar Waters Corporation, Milford, MA, U.S. INTRODUCTION EXPERIMENTAL RESULTS AND DISCUSSION
UPLC Separation of DNA Duplexes Sean M. McCarthy and Martin Gilar Waters Corporation, Milford, MA, U.S. INTRODUCTION Over the past 2 years there has been a considerable amount of effort focused on the
More informationQuality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities
Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities S. Karmarkar*, R. Garber, Y. Genchanok, S. George, X. Yang, and R. Hammond Baxter Healthcare Corporation,
More informationfor IND and RDRC Regulated PET Compounding
Overview of USP Chapter for IND and RDRC Regulated PET Compounding Distributed Manufacturing of PET Radiopharmaceuticals for Multi-Center Clinical Trials SNM, Annual Meeting Toronto, Ontario, Canada
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 AAB Cert# AR-1470 ISO/IEC 17025 AAB Cert# AT-1467 FLUCOAZOLE CERTIFIED REFERECE MATERIAL F OH F CERTIFIED PURITY: 99.6%, U crm = ±0.2% k = 2 (Mass Balance/as is basis)
More informationNonsterile Compounding: USP and Best Practices for Community Pharmacists
Nonsterile Compounding: USP and Best Practices for Community Pharmacists Target Audience: Pharmacists and Pharmacy Technicians ACPE#: 0202-0000-18-033-L07-P/T Activity Type: Knowledge-based Disclosures
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 ANAB Cert# AR-1470 ISO/IEC 17025 ANAB Cert# AT-1467 SORBITOL CERTIFIED REFERENCE MATERIAL CERTIFIED PURITY: 98.4 %, U crm = ±0.1 % k = 2 (Mass Balance/as is basis)
More informationDeveloping Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus
Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus Robert Birdsall, Thomas Wheat, and Weibin Chen Waters Corporation,
More informationApplication Note. Authors. Abstract. Introduction. Pharmaceutical
Scalability of Agilent s Across HPLC and UHPLC Instruments Application Note Pharmaceutical Authors Anne E. Mack, William J. Long Agilent Technologies, Inc. 2850 Centerville Road, Wilmington, DE 19808 USA
More informationDACLATASVIR TABLETS (DACLATASVIRI COMPRESSI) Proposal for The International Pharmacopoeia. (May 2018)
May 2018 Draft for comment 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 DACLATASVIR TABLETS (DACLATASVIRI COMPRESSI) Proposal for The International
More informationCertificate of Analysis
Certificate of Analysis ISO GUIDE 34 ANAB Cert# AR-1470 ISO/IEC 17025 ANAB Cert# AT-1467 SODIUM BENZOATE CERTIFIED REFERENCE MATERIAL CERTIFIED PURITY: 99.8%, U crm = ±0.1% k = 2 (Mass Balance/as is basis)
More informationPerformance Characteristics of the Agilent 1220 Infinity Gradient LC system
Performance Characteristics of the Agilent 122 Infinity Gradient LC system An integrated LC system for conventional LC and UHPLC Technical Overview 7 5 4 3 2 1.5 1 1.5 2 2.5 3 Introduction The Agilent
More information