Outline of an Analytical Profiles of Drug Substances and Excipients Monograph
Although the identity of the actual compound will dictate the exact content of
an analytical profile, the following typical table of contents describes the
range of information normally included. Should a prospective author be unable
to complete all indicated sections, then the editor will find a co-author who
will write the remainder of the chapter.
1. Description
1.1 Nomenclature
1.1.1 Chemical Name
1.1.2 Nonproprietary Names
1.1.3 Proprietary Names
1.2 Formulae
1.2.1 Empirical
1.2.2 Structural
1.3 Molecular Weight
1.4 CAS Number
1.5 Appearance
1.6 Uses and Applications
2. Method(s) of Preparation
3. Physical Properties
3.1 Particle Morphology
3.2 Crystallographic Properties
3.2.1 Single Crystal Structure
3.2.2 Polymorphism
3.2.3 X-Ray Powder Diffraction Pattern
3.3 Optical Activity
3.3.1 Optical Rotation
3.3.2 Circular Dichroism
3.4 Thermal Methods of analysis
3.4.1 Melting Behavior
3.4.2 Differential Scanning Calorimetry
3.4.3 Thermogravimetric Analysis
3.5 Hygroscopicity
3.6 Solubility Characteristics
3.7 Partition Coefficients
3.8 Ionization Constants
3.9 Spectroscopy
3.9.1 UV/VIS Spectroscopy
3.9.2 Vibrational Spectroscopy
3.9.3 Nuclear Magnetic Resonance Spectrometry
3.9.3.1 1H-NMR Spectrum
3.9.3.2 13C-NMR Spectrum
3.9.4 Mass Spectrometry
3.10 Electrochemistry
4. Methods of Analysis
4.1 Compendial Tests
4.2 Identification
4.3 Elemental Analysis
4.4 Titrimetric Analysis
4.5 Electrochemical Analysis
4.6 Spectrophotometric Methods of Analysis
4.7 Fluorimetric Methods of Analysis
4.8 Chromatographic Methods of Analysis
4.8.1 Thin Layer Chromatography
4.8.2 Gas Chromatography
4.8.3 High Performance Liquid Chromatography
4.9 Determination in Body Fluids and Tissues
5. Stability
5.1 Solid-State Stability
5.2 Solution-Phase Stability
5.3 Stability in Biological Fluids
5.4 Incompatibilities with Functional Groups
6. Drug Metabolism and Pharmacokinetics
6.1 Adsorption
6.2 Distribution
6.3 Metabolism
6.4 Elimination
7. References
[examples of format to be used]
|
journal article
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1. P.N. Shaw, A.L. Sivner, L. Aarons, and J.B. Houston,
J. Chromatogr.
, 274, 393-397 (1983).
| |
book
|
2.
The Merck Index
, 11th Edition, S. Budavari, ed., Merck and Co., Inc., Rahway, N.J., 1989.
| |
chapter in book
|
3. S.B. Hanauer, "Topical and Oral Aminosalicylates", in
The Management of Inflammatory Bowel Disease: New Medical and Surgical
Approaches
, M. Peppercorn, ed., Marcel Dekker, Philadelphia, 1990, pp. 65-91.
| |
patent citation
|
4. H.A. Shelanski, Mixture of polymeric N-vinylpyrrolidone and halogens,
U.S. Patent 2,739,922
, March 27, 1956.
|
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