Analytical
Links and Resources |
by Carvalhas & Tavares |
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