Contents-日本药典目录英文版

CONTENTS

Preface (i)

The Japanese Pharmacopoeia,Sixteenth 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

1.01Alcohol Number Determination (25)

1.02Ammonium Limit Test (27)

1.03Chloride Limit Test (28)

1.04Flame Coloration Test (28)

1.05Mineral Oil Test (28)

1.06Oxygen Flask Combustion Method (28)

1.07Heavy Metals Limit Test (29)

1.08Nitrogen Determination(Semimicro-

Kjeldahl Method) (30)

1.09Qualitative Tests (31)

1.10Iron Limit Test (37)

1.11Arsenic Limit Test (37)

1.12Methanol Test (39)

1.13Fats and Fatty Oils Test (39)

1.14Sulfate Limit Test (41)

1.15Readily Carbonizable Substances Test (41)

2.Physical Methods

Chromatography

2.01Liquid Chromatography (42)

2.02Gas Chromatography (45)

2.03Thin-layer Chromatography (47)

2.04Amino Acid Analysis of Proteins (47)

Spectroscopic Methods

2.21Nuclear Magnetic Resonance

Spectroscopy (48)

2.22Fluorometry (50)

2.23Atomic Absorption

Spectrophotometry (51)

2.24Ultraviolet-visible Spectrophotometry (52)

2.25Infrared Spectrophotometry (53)

Other Physical Methods

2.41Loss on Drying Test (55)

2.42Congealing Point Determination (55)

2.43Loss on Ignition Test (56)

2.44Residue on Ignition Test (56)

2.45Refractive Index Determination (56)

2.46Residual Solvents Test (57)

2.47Osmolarity Determination (57)

2.48Water Determination(Karl Fischer

Method) (58)

2.49Optical Rotation Determination (61)

2.50Endpoint Detection Methods in

Titrimetry (62)

2.51Conductivity Measurement (63)

2.52Thermal Analysis (65)

2.53Viscosity Determination (67)

2.54pH Determination (69)

2.55Vitamin A Assay (71)

2.56Determination of Specific Gravity and

Density (72)

2.57Boiling Point and Distilling Range

Test (74)

2.58X-Ray Powder Diffraction Method (75)

2.59Test for Total Organic Carbon (79)

2.60Melting Point Determination (80)

3.Powder Property Determinations

3.01Determination of Bulk and Tapped

Densities (82)

3.02Specific Surface Area by Gas

Adsorption (84)

3.03Powder Particle Density

Determination (86)

3.04Particle Size Determination (87)

4.Biological Tests/Biochemical Tests/

Microbial Tests

4.01Bacterial Endotoxins Test (92)

4.02Microbial Assay for Antibiotics (96)

4.03Digestion Test (100)

4.04Pyrogen Test (103)

4.05Microbial Limit Test (103)

4.06Sterility Test (114)

5.Tests for Crude Drugs

5.01Crude Drugs Test (117)

5.02Microbial Limit Test for Crude Drugs (120)

6.Tests for Preparations

6.01Test for Metal Particles in Ophthalmic

Ointments (126)

6.02Uniformity of Dosage Units (127)

6.03Particle Size Distribution Test for

Preparations (129)

6.04Test for Acid-neutralizing Capacity of

Gastrointestinal Medicines (129)

6.05Test for Extractable Volume of

Parenteral Preparations (130)

6.06Foreign Insoluble Matter Test for

Injections (131)

6.07Insoluble Particulate Matter Test for

Injections (131)

6.08Insoluble Particulate Matter Test for

Ophthalmic Solutions (134)

6.09Disintegration Test (135)

6.10Dissolution Test (137)