Fumiaki Akahori – The Japanese Pharmacopoeia (17th edition, 2017)

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Автор: Fumiaki Akahori
Название книги: The Japanese Pharmacopoeia (17th edition, 2017)
Формат: PDF
Жанр: Медицина
Страницы: 2650
Качество: Изначально компьютерное, E-book

The Japanese Pharmacopoeia 17th edition (JP XVII) English translation is fully endorsed by the society of the Japanese Pharmacopoeia. It defines the specifications, criteria and standard test methods necessary to properly ensure the quality of medicines in Japan. The Japanese language edition was effective from 1st April 2016.

Key features:
General Notices, General Rules for Crude Drugs, General Rules for Preparations: revised and expanded.
Official monographs: 76 new monographs and 473 revised monographs.
General tests, processes and apparatus: 23 new standards and 10 revised standards.
Infrared reference spectra: 21 new spectra and 2 revised spectra.
Ultraviolet-visible reference spectra: 14 new spectra and 2 revised spectra.

Contents:

Preface……………………………………………………i
The Japanese Pharmacopoeia, Seventeenth Edition..1
General Notices ………………………………………1
General Rules for Crude Drugs…………………….5
General Rules for Preparations…………………….7
General Tests, Processes and Apparatus…………25
1. Chemical Methods
1.01 Alcohol Number Determination …………..25
1.02 Ammonium Limit Test …………………….27
1.03 Chloride Limit Test…………………………28
1.04 Flame Coloration Test ……………………..28
1.05 Mineral Oil Test …………………………….28
1.06 Oxygen Flask Combustion Method……….28
1.07 Heavy Metals Limit Test …………………..29
1.08 Nitrogen Determination (Semimicro-
Kjeldahl Method)…………………………30
1.09 Qualitative Tests…………………………….31
1.10 Iron Limit Test ……………………………..36
1.11 Arsenic Limit Test ………………………….37
1.12 Methanol Test……………………………….38
1.13 Fats and Fatty Oils Test ……………………38
1.14 Sulfate Limit Test …………………………..40
1.15 Readily Carbonizable Substances Test ……41
2. Physical Methods
Chromatography
2.01 Liquid Chromatography……………………41
2.02 Gas Chromatography ………………………44
2.03 Thin-layer Chromatography ……………….46
2.04 Amino Acid Analysis of Proteins …………46
Spectroscopic Methods
2.21 Nuclear Magnetic Resonance
Spectroscopy………………………………47
2.22 Fluorometry …………………………………49
2.23 Atomic Absorption
Spectrophotometry……………………….49
2.24 Ultraviolet-visible Spectrophotometry…….51
2.25 Infrared Spectrophotometry ……………….52
Other Physical Methods
2.41 Loss on Drying Test ………………………..53
2.42 Congealing Point Determination ………….54
2.43 Loss on Ignition Test……………………….54
2.44 Residue on Ignition Test …………………..55
2.45 Refractive Index Determination …………..55
2.46 Residual Solvents……………………………55
2.47 Osmolarity Determination …………………61
2.48 Water Determination (Karl Fischer
Method)……………………………………62
2.49 Optical Rotation Determination …………..65
2.50 Endpoint Detection Methods in
Titrimetry …………………………………66
2.51 Conductivity Measurement ………………..68
2.52 Thermal Analysis……………………………69
2.53 Viscosity Determination ……………………71
2.54 pH Determination…………………………..74
2.55 Vitamin A Assay ……………………………75
2.56 Determination of Specific Gravity and
Density …………………………………….76
2.57 Boiling Point and Distilling Range
Test ………………………………………..78
2.58 X-Ray Powder Diffraction Method ………79
2.59 Test for Total Organic Carbon ……………83
2.60 Melting Point Determination………………84
2.61 Turbidity Measurement …………………….85
2.62 Mass Spectrometry………………………….86
2.63 Inductively Coupled Plasma-Atomic
Emission Spectrometry and Inductively
Coupled Plasma-Mass Spectrometry …..91
2.64 Glycosylation Analysis of Glycoprotein ….95
2.65 Methods for Color Matching………………96
3. Powder Property Determinations
3.01 Determination of Bulk and Tapped
Densities …………………………………..98
3.02 Specific Surface Area by Gas
Adsorption ………………………………100
3.03 Powder Particle Density
Determination …………………………..103
3.04 Particle Size Determination ………………104
3.05 Water-Solid Interactions: Determination of
Sorption-Desorption Isotherms and of
Water Activity …………………………..108
4. Biological Tests/Biochemical Tests/
Microbial Tests
4.01 Bacterial Endotoxins Test ………………..110
4.02 Microbial Assay for Antibiotics………….114
4.03 Digestion Test ……………………………..117
4.04 Pyrogen Test ……………………………….120
4.05 Microbiological Examination of Non-sterile
Products………………………………….121
4.06 Sterility Test………………………………..130
5. Tests for Crude Drugs
5.01 Crude Drugs Test ………………………….134
5.02 Microbial Limit Test for Crude Drugs and
Preparations containing Crude Drugs as
Main Ingredient …………………………138
6. Tests for Preparations
6.01 Test for Metal Particles in Ophthalmic
Ointments………………………………..147
6.02 Uniformity of Dosage Units ……………..147
6.03 Particle Size Distribution Test for
Preparations……………………………..150
6.04 Test for Acid-neutralizing Capacity of
Gastrointestinal Medicines……………..150
6.05 Test for Extractable Volume of
Parenteral Preparations ………………..150
6.06 Foreign Insoluble Matter Test for
Injections ………………………………..151
6.07 Insoluble Particulate Matter Test for
Injections ………………………………..151
6.08 Insoluble Particulate Matter Test for
Ophthalmic Solutions…………………..154
6.09 Disintegration Test ………………………..155
6.10 Dissolution Test ……………………………157
6.11 Foreign Insoluble Matter Test for
Ophthalmic Liquids and Solutions ……161
6.12 Methods of Adhesion Testing ……………161
6.13 Release Test for Preparations for Cutaneous
Application ………………………………163
7. Tests for Containers and Packing Materials
7.01 Test for Glass Containers for Injections ..166
7.02 Test Methods for Plastic Containers…….167
7.03 Test for Rubber Closure for Aqueous
Infusions …………………………………172
9. Reference Standards; Standard Solutions;
Reagents, Test Solutions; Measuring
Instruments, Appliances, etc.
Reference Standards
9.01 Reference Standards ………………………174
Standard Solutions
9.21 Standard Solutions for Volumetric
Analysis ………………………………….177
9.22 Standard Solutions ………………………..189
9.23 Matching Fluids for Color ……………….191
Reagents, Test Solutions, etc.
9.41 Reagents, Test Solutions ………………….191
9.42 Solid Supports/Column Packings for
Chromatography ………………………..352
9.43 Filter Papers, Filters for filtration,
Test Papers, Crucibles, etc. ……………354
9.44 Standard Particles, etc…………………….355
Measuring Instruments and Appliances,
Thermometers, etc.
9.61 Optical Filters for Wavelength and
Transmission Rate Calibration ………..355
9.62 Measuring Instruments, Appliances……..355
9.63 Thermometers ……………………………..356
Official Monographs ………………………………..359
Crude Drugs and Related Drugs ……………….1791
Infrared Reference Spectra …………………2015–2222
Ultraviolet-visible Reference Spectra ………2225–2405
General Information
G1 Physics and Chemistry
Near Infrared Spectrometry………………….2409
pH Test for Gastrointestinal Medicine ……..2412
System Suitability……………………………..2412
Test for Trace Amounts of Aluminum in
Total Parenteral Nutrition (TPN)
Solutions …………………………………….2414
Validation of Analytical Procedures ………..2415
G2 Solid-state Properties
Laser Diffraction Measurement of
Particle Size …………………………………2418
Measurement of the Diameter of Particles
Dispersed in Liquid by Dynamic Light
Scattering ……………………………………2422
Powder Fineness ………………………………2424
Powder Flow…………………………………..2425
Solid and Particle Densities ………………….2427
G3 Biotechnological/Biological Products
Amino Acid Analysis …………………………2428
Basic Requirements for Viral Safety of
Biotechnological/Biological Products
listed in Japanese Pharmacopoeia ………..2435
Capillary Electrophoresis …………………….2447
Isoelectric Focusing …………………………..2452
Mass Spectrometry of Peptides and
Proteins ……………………………………..2454
Monosaccharide Analysis and Oligosaccharide
Analysis/Oligosaccharide Profiling ………2456
Mycoplasma Testing for Cell Substrates used
for the Production of Biotechnological/
Biological Products…………………………2460
Peptide Mapping………………………………2464
Qualification of Animals as Origin of
Animal-derived Medicinal Products
provided in the General Notices of
Japanese Pharmacopoeia and Other
Standards ……………………………………2467
SDS-Polyacrylamide Gel Electrophoresis …..2469
Surface Plasmon Resonance …………………2474
Total Protein Assay …………………………..2478
G4 Microorganisms
Decision of Limit for Bacterial
Endotoxins ………………………………….2481
Disinfection and Decontamination Methods
……………………………………………….2481
Media Fill Test (Process Simulation) ……….2484
Microbial Attributes of Non-sterile
Pharmaceutical Products ………………….2486
Microbiological Environmental Monitoring
Methods of Processing Areas for Sterile
Pharmaceutical Products ………………….2489
Parametric Release of Terminally Sterilized
Pharmaceutical Products ………………….2494
Preservatives-Effectiveness Tests…………….2499
Rapid Counting of Microbes using
Fluorescent Staining………………………..2501
Rapid Identification of Microorganisms
Based on Molecular Biological Method ….2503
Rapid Microbial Methods ……………………2505
Sterilization and Sterilization Indicators ……2507
G5 Crude Drugs
Analytical Methods for Aflatoxins in Crude
Drug and Crude Drug Preparations ……..2513
Aristolochic Acid ……………………………..2515
Notification for the Quantitative Marker
Constituents of Crude Drugs and Crude
Drug Preparations ………………………….2515
Purity Tests on Crude Drugs using Genetic
Information …………………………………2516
Quantitative Analytical Technique Utilizing
Nuclear Magnetic Resonance (NMR)
Spectroscopy and its Application to Reagents
in the Japanese Pharmacopoeia…………..2519
On the Scientific Names of Crude Drugs
listed in the JP ……………………………..2520
Thin-layer Chromatography for Crude Drugs
and Crude Drug Preparations …………….2534
G6 Drug Formulation
Standard Procedure for Mechanical Calibration
of Dissolution Apparatus ………………….2536
Tablet Friability Test …………………………2538
G7 Containers and Package
Basic Requirements and Terms for the Packaging
of Pharmaceutical Products……………….2538
Basic Requirements for Plastic Containers for
Pharmaceutical Use and Rubber Closures for
Containers for Aqueous Infusions ……….2542
G8 Water
Quality Control of Water for Pharmaceutical
Use …………………………………………..2543
Water to be used in the Tests of Drugs …….2550
G9 Reference Standards
Reference Standards and Reference Materials
Specified in the Japanese Pharmacopoeia
……………………………………………….2550
G10 Others
Basic Concepts for Quality Assurance of Drug
Substances and Drug Products ……………2553
Basic Concept of Quality Risk Management..2554
International Harmonization Implemented
in the Japanese Pharmacopoeia Seventeenth
Edition……………………………………….2557
Appendix
Atomic Weight Table (2010) ………………………2595
Standard Atomic Weights 2010 …………………..2596
Index…………………………………………………2599
Index in Latin name ……………………………….2616
Index in Japanese…………………………………..2618

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