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Analytical Links and Resources

Encyclopedia of Analytical Instrumentation

The Analytical Chemistry Springboard

Analytical Chemistry

Tutorials on molecular spectroscopy and chromatography

IUPAC Nomenclature - Recommendations on Organic & Biochemical Nomenclature, Symbols & Terminology etc.

Chromatography

IUPAC Nomenclature for Chromatography

International Adsorption Society

Chemical Separations

Chromatography Systems

(UK) Chromatography Society

Chromatography - A Short Introduction

Chemical Separations

Chromatography.co.uk - Chromatographic hints, tips and FAQs

HPLC  

LC -GC

LC troubleshooting - possible causes and solutions (LC-GC)

UNLisboa - The HPLC troubleshooter

Liquid Chromatography Data Base

Basic Liquid Chromatography

Introduction to liquid chromatography

A Guide to HPLC

HPLC glossary

Waters - Glossary of HPLC Terms

Liquid Chromatography Books with short Abstracts

Chemiluminescent Reactions and Liquid Chromatography

 

GC

Start GC! Gas Chromatography and Applications

GC Troubleshooting Guide (LC-GC)

Gas chromatography (Chemical Separations - Presentation)

Selecting GC Columns

 

GC-MS

Coupling Gas Chromatography to Mass Spectrometry

LC-MS

Liquid Chromatography / Mass Spectrometry

Chiral Chromatography

Online Guide to Chiral HPLC

ChromTech - Chiral separation of enantiomers

Regis - Chiral Separations by HPLC

Chirbase - Commercially Available Chiral Stationary Phases

Chiral HPLC Applications from Regis Technologies

 

Spectrometry / Spectrophotometry

Galactic Spectral Database (IV-FTIR;MS;NRM)

CHIRAL - CD-UV Database - Search

Society for Applied Spectroscopy

NIST Physical Reference Data - Atomic Spectroscopic Data

IR Wizard

Fourier Transform Infrared Spectroscopy at Aberystwyth

Important Tips for UV-VIS Spectroscopy

Typical solvents and approximate UV cutoff wavelengthsy

 

Mass Spectrometry - MS

Base Peak - Mass Spectrometry Resource from Wiley

Links to Mass Spectrometry Internet Sites

Introduction to Mass Spectrometry

MASPEC Online

Mass Spectrometry Internet Resources FAQ

0nline SpectroscopyTrouble Shooting Guide

Mass Spectroscopy for Chromatographers

Pyrolysis Mass Spectrometry at Aberystwyth

 

MS - Organizations

American Society for Mass Spectrometry - (ASMS)

Australian and New Zealand Society for Mass Spectrometry - (ANZSMS)

Belgian Society for Mass Spectrometry - (BSMS)

British Mass Spectrometry Society

Canadian Society for Mass Spectrometry - (CSMS)

Dutch Society for Mass Spectrometry - (NVMS)

European Society for Mass Spectrometry - (ESMS)

International Mass Spectrometry Society - (IMSS)

Irish Mass Spectrometry Society - (IMSS)

Italian Home Page on Mass Spectrometry

Le Club des Jeunes Spectrométristes de Masse (CJSM)

Mass Spectrometry Society of Japan - (MSSJ)

Norsk Selskap for Massespektrometri - (NSMS)

Polish Mass Spectrometry Society - (PMSS)

South African Mass Spectrometry Association - (SAAMS)

Sociedad Española de Espectrometría de Masas (SEEM)

Svenska Masspektrometrisällskapet (SMSS)

Swiss Group for Mass Spectrometry - (SGMS)

 

MS - Discussion Groups

Mass Spectrometry News Group

The Usenet Mass Spectrometry Newsgroup

ASMS - Groups

 

Electrophoresis

EC

Short introduction to Capillary Electrophoresis

Two-Dimensional Gel Electrophoresis Databases - Lists

CESONE - Capillary Electrophoresis Society of New England

The Electrophoresis Society

 

Other utilities

ZirChrom - Buffer Wizard

Buffer Design

 

DataBases

NIST Standard Reference Database

Galactic Spectral Database (IV-FTIR;MS;NRM)

CHIRAL - CD-UV Database - Search

FDM - Reference Spectra, Chemical Information

 

 Reference Substances, reagents and pharmaceutical excipients, etc

3M Drug Delivery Systems

AbsoluteStandards

AccuStandard

Airgas

Air Liquide 

Air Liquide 

BFGoodrich Pharmaceuticals

Croda Inc.

Chemical Manufacturers

European Pharmacopoeia - CRS catalogue

ExtraSynthese

Fischer Chemicals AG

Henkel - Ibérica

Merck Chemical and Laboratory Supplies

Miller Freeman BV

Promochem

Research Organics

Sigma-Aldrich-Fluka-Supelco-RDH

Sourcerer chemicals supplies

Spectrum Chemicals

SPEX CertiPrep

TCI America

USP - Reference Standards catalog

Who - Reference Substances for Pharmacopoeial Analysis

Who - International chemical references substances

Who - Infrared reference spectra

 

Analytical Validation (Documents)

Q2A: Validation of analytical procedures - Definitions and Terminology (ICH October 1994)ICH October 1994)

Q2B: Validation of analytical procedures - Methodology (ICH November 1996)

 

Note for Guidance on Validation of Analytical Procedures: Methodology (CPMP adopted December 96)

Note for Guidance on Validation of Analytical Methods: Definitions and Terminology (CPMP adopted Nov. 94)

Note for Guidance on Process Validation (CPMP Draft)

 

FDA - CDER - Reviewer Guidance, Validation of Chromatographic Methods

FDA - CDER - Bioanalytical Methods Validation for Human Studies

FDA - CDER - General Principles of Process Validation

FDA - CDER - Analytical Procedures and Methods Validation

FDA - CDER - Other Validation related documents

 

BioPharm, Vol 12, March 1999, Pages 64/66 - Validation of HPLC Methods

LC-GC, 1997-1, Version February 21, 1999 - Validation of Analytical Methods:Review and Strategy

LC-GC volume 16(12), December 1998  - Quantitation in Method Validation

Pharmaceutical Technology, February 1998 - Evaluation and Validation of Standard Methods

Drug Information Journal, Vol. 31, pp. 1195-1201, 1997 - SHEIN-CHUNG CHOW,PHD - Pharmaceutical Validation And Process Controls In Drug Evelopment

DuPont Packaging and Industrial Polymers Research - Charles E. Miller - The Use of Chemometric Techniques in Process Analytical Method Development and Operation

Analytical Chemistry 1996, (68) 305A-309A  - A Practical Guide to Analytical Method Validation

Eurachem - Publications  - The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)

 

 

Dissolution / IVIV correlation / Bioequivalence (Documents)

Note For Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Quality) (CPMP - Draft)

 FDA - CDER Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997)

FDA - CDER Oral Extended (Controlled) Release Dosage Forms in Vivo Bioequivalence and in Vitro Dissolution Testing

FDA - CDER SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation

FDA - CDER SUPAC-IR/MR: Immediate Release aand Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (Issued 1/1999)

FDA - CDER SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997)

FDA - CDER SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997)

Note For Guidance on the Investigation of Bioavailability and Bioequivalence (CPMP - Draft - CPMP/EWP/QWP/1401/98 )

 

FDA - CDER Food-Effect Bioavailability and Bioequivalence Studies (Issued 10/1997)

FDA - CDER In Vivo Bioequiv. Studies Based on Population and Individual Bioequivalence Studies (Issued 12/10/1997)

FDA - CDER Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies (Issued 6/18/1998)

FDA - CDER Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System (Issued 1/1999, Posted 2/16/1999)

FDA - CDER Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (Issued 7/1992, Posted 10/5/98)

FDA - CDER Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Issued 6/1999, Posted 6/2/1999)

EUDRALEX - Volume 3C - EFFICACY - Clinical Guidelines (General) - Investigation of Bioavailability and Bioequivalence.

CANADA - Preparation of Drug Submissions: Comparative Bioavailability Studies (October 8, 1997)

CANADA - Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations used for Systemic Effects 1992 

CANADA - Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations - July 23, 1997 

 

 

Stability and Impurities Testing (Documents)

Note for Guidance on Stability Testing for a Type II Variation to a Marketing Authorisation (CPMP adopted Apr.98)

Note for Guidance on Stability Testing of existing Active Substances and Related Finished Products (CPMP adopted Apr.98)

Note for guidance on Stability Testing of New Active Substances and Medicinal Products: Maximum Shelf-Life for Sterile Products after First Opening or following Reconstitution (CPMP adopted Jan. 98)

Note for guidance on Stability Testing of New Active Substances and Medicinal Products: Declaration of Storage Conditions for Medicinal Products in the Product Particulars (CPMP adopted Jan. 98)

Reduced Stability Testing Plan - Bracketing and Matrixing: Annex to Note for Guidance on Stability Testing of New Drug Substances and Products (CPMP/ICH/380/95)(CPMP adopted Oct. 97)

Note for Guidance on Photostability testing of New Active Substances and Medicinal products(CPMP adopted December 96)

Note for Guidance on Stability Testing: Requirements for New Dosage Forms(CPMP adopted December 96)

Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products(CPMP adopted Dec. 93)

(Topic Q1A, Step 2) Note for Guidance on Stability Testing of New Drug Substances and Products (Revision of CPMP/ICH/380/95, released for consultation Nov. 99) (CPMP/ICH/2736/99)

(Topic Q3A, Step 2) Note for Guidance on Impurities Testing: Impurities in New Drug Substances (Revision of CPMP/ICH/142/95, released for consultation Nov. 99) (CPMP/ICH/2737/99)

(Topic Q3B, Step 2) Note for Guidance on Impurities in New Drug Products (Revision of CPMP/ICH/282/95, released for consultation Nov. 99) (CPMP/ICH/2738/99)

 

FDA - CDER Submitting Documentation for the Stability of Human Drugs and Biologics (Issued 2/1987)

FDA - CDER Stability Testing of Drug Substances and Drug Products (Issued 6/5/98)

FDA - CDER Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (Issued 6/27/1997)

FDA - CDER Q1A Stability Testing of New Drug Substances and Products (Issued 5/16/1997)

FDA - CDER Q1B Photostability Testing of New Drug Substances and Products (Issued 11/1996)

FDA - CDER Q1C Stability Testing for New Dosage Forms (Issued 5/9/1997)

FDA - CDER Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products

 

 

Pharmacopoeial Harmonization and Specifications (Documents)

Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP -Draft)

Note for guidance on Specifications: Test Procedures and acceptance Criteria for New Drug (CPMP -Draft)

 

FDA - CDER Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Issued 11/1997)

FDA - CDER Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Issued 6/9/98)

FDA - CDER Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 30/9/98)

 

 

 Topical Formulations (Documents)

FDA - CDER SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997)

FDA - CDER SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (Issued 12/1998, Posted 1/5/1999)

FDA - CDER Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies (Issued 6/18/1998)

Note for Guidance on the Clinical Requirements for Locally Applied, Locally Acting Products containing Known Constituents (CPMP adopted Nov.95)

Note for Guidance on the Clinical Requirements for Locally Applied, Locally Acting Products containing Known Constituents (CPMP adopted Nov.95)

Note For Guidance on Quality of Modified Release Products:A.Oral Dosage Forms; B. and Transdermal Dosage Forms; Section I (Quality)

 

 

Suppliers

Agilent Technologies Chemical Analysis

AMD Intectra

Analyticon - Directory of Manufacturers/Suppliers

BASF

Bear Instruments

Beckman

Chromacol

Chrompack

Cole-Parmer

Comstock Inc.

CSS Analytical Company

Development Centre for Chromatography and Mass Spectrometry, sprl

Eppendorf

Erweka

ETP Scientific

Finnigan

Gilson

GSG Analytical Instruments

Hanson

Hitachi

International Sorbent Technology

Ion Source Software

Jasco Inc

JEOL USA

Kore Technology

Kratos Analytical

LabControl

LC Packings

LECO Corporation

Macherey-Nagel Corporation

MasCom GmbH

Mass Evolution

Merck Chromatography

Metrohm

Mettler

Micromass

Millipore

M-Scan

NIST - National Institute of Standards and Technology

Palisade

PermeGear -Transdermal Diffusion Apparatus

Perkin-Elmer

Pharmaceutical Processing Online - Pharmaceutical Ingredients Suppliers

Pharmacia Biotech

Polymer Laboratories

Sartorius

SGE

Shimadzu

SIS Web

Scientific Software

Soquimica

Sotax

Supelco

TC Technical Services

ThermoQuest Austin

Unicam

VanKel

Varian

Vydac

Waters

Whatman

Wyatt Technology

 

Software

Mass Spectrometry Software

Adept Scientific