ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health
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APPENDIX 1 GENERAL INFORMATION | 294 |
1.1 Reagents | 294 |
1.2 Volumetric Solutions | 322 |
1.3 Standard Solutions | 325 |
1.4 pH Indicators | 326 |
1.5 Buffer Solutions | 330 |
1.6 Test Solutions | 331 |
1.7 Materials for Chromatography | 335 |
1.8 Reference Substances | 336 |
1.9 Volumetric Apparatus | 337 |
1.10 Weights and Balances | 338 |
1.11 Powder Fineness and Sieves | 339 |
1.13 Names, Symbols and Atomic Weights of Elements | 341 |
1.14 Weights and Measures: SI Units | 342 |
1.15 Medicine Dropper | 343 |
1.16 Pharmaceutical Dosage Forms | 343 |
1.17 Estimation of Body Surface Area | 368 |
1.18 Estimation of Lean Body Weight |
371 |
APPENDIX 2 SPECTROSCOPY | 372 |
2.1 Infrared Spectrophotometry | 372 |
2.2 Ultraviolet and Visible Spectrophotometry | 374 |
2.3 Atomic Spectrometry: Emission and Absorption | 377 |
2.4 Fluorescence Spectrophotometry | 378 |
2.5 Turbidimetry and Nephelometry | 379 |
2.6 Raman Spectrometry | 380 |
2.7 X-Ray Fluorescence Spectrometry | 381 |
2.8 Mass Spectrometry | 382 |
2.9 Nuclear Magnetic Resonance Spectrometry | 385 |
APPENDIX 3 CHROMATOGRAPHY AND ELECTROPHORESIS | 387 |
3.1 Thin-layer Chromatography | 387 |
- Identification of Steroids | 389 |
- Related Impurities in Phenothiazines | 390 |
- Related Foreign Steroids | 390 |
- Related Substances in Sulfonamides | 390 |
3.2 Paper Chromatography | 391 |
3.3 Column Chromatography | 392 |
3.4 Gas Chromatography | 394 |
3.5 High-pressure Liquid Chromatography | 396 |
3.6 Size-exclusion Chromatography | 398 |
3.7 Electrophoresis | 399 |
3.8 Capillary Electrophoresis | 408 |
3.9 Chromatographic Separation Techniques | 415 |
APPENDIX 4 PHYSICAL TESTS | 419 |
4.1 Clarity of Solution | 419 |
4.2 Colour of Solution | 420 |
4.3 Determination of Melting Range and Melting Temperature | 421 |
4.4 Determination of Freezing Temperature | 423 |
4.5 Determination of Boiling Range (Distillation Range) | 424 |
4.6 Determination of Boiling Temperature | 425 |
4.7 Determination of Refractive Index | 425 |
4.8 Determination of Optical Rotation and Specific Rotation | 425 |
4.9 Determination of Weight per Millilitre, Specific Gravity and Relative Density | 427 |
4.10 Determination of Viscosity | 428 |
4.11 Determination of pH | 432 |
4.12 Determination of Water | 433 |
4.13 Determination of Insoluble Matter | 436 |
4.14 Crystallinity | 436 |
4.15 Loss on Drying | 437 |
4.16 Loss on Ignition | 437 |
4.18 X-ray Diffraction | 437 |
4.21 Deliverable Volume | 440 |
4.22 Disintegration Test for Suppositories and Pessaries | 441 |
4.23 Disintegration Test for Tablets and Capsules | 442 |
4.24 Dissolution Test | 445 |
4.26 Minimum Fill | 450 |
4.27 Particulate Matter in Injections | 451 |
4.28 Uniformity of Dosage Units | 454 |
4.30 Friability of Uncoated Tablets | 460 |
4.31 Resistance to Crushing of Tablets | 460 |
4.32 Apparent Volume | 461 |
4.33 Flowability | 461 |
4.34 Powder Flow | 462 |
4.35 Osmolality | 465 |
4.36 Total Organic Carbon | 466 |
4.37 Water Conductivity | 467 |
4.38 Analytical Filtration by Filter Paper | 469 |
APPENDIX 5 CHEMICAL TESTS | 470 |
5.1 General Identification Tests | 470 |
5.2 Limit Tests for | 474 |
Aluminium |
474 |
5.3 Determination of Sulfated Ash | 480 |
5.4 Acid Value | 480 |
5.5 Ester Value | 480 |
5.6 Iodine Value | 480 |
5.7 Saponification Value | 481 |
5.8 Unsaponifiable Matter | 481 |
5.9 Hydroxyl Value | 482 |
5.10 Solidification Temperature of Fatty Acids | 483 |
5.11 Determination of Esters | 483 |
5.12 Peroxide Value | 483 |
5.13 Acid-neutralizing Capacity | 483 |
5.14 Relationship Between Reaction of Solution, Approximate pH and Colour of Certain Indicators |
484 |
5.15 Determination of Methanol and 2-Propanol | 485 |
5.16 N, N-Dimethylaniline (Dimethylaniline) | 486 |
5.17 Ordinary Impurities | 486 |
APPENDIX 6 ASSAYS | 488 |
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6.1 Non-aqueous Titration | 488 |
6.2 Oxygen Flask Combustion | 489 |
6.3 Complexometric Titrations | 490 |
6.4 Potentiometry | 491 |
6.4.1 Potentiometric Titration |
492 492 |
6.5 Determination of Ethanol | 494 |
6.6 Determination of Methoxyl | 498 |
6.7 Determination of Nitrogen | 499 |
6.10 Biological Assay of Antibiotics | 500 |
6.17 Residual Titrations | 509 |
6.22 Content of Antimicrobial Agents | 509 |
6.25 Polarography | 512 |
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APPENDIX 7 CRUDE DRUGS | 516 |
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7.1 Sampling | 516 |
7.2 Foreign Matter | 516 |
7.3 Determination of Volatile Oil | 516 |
7.6 Acid-insoluble Ash | 518 |
7.7 Total Ash | 518 |
7.8 Determination of Cineole | 518 |
7.9 Determination of Aldehydes | 519 |
7.10 Swelling Index | 519 |
7.11 Water-soluble Ash | 519 |
7.12 Extractives | 519 |
7.13 Residue on Evaporation of Volatile Oils | 519 |
7.21 Total Solids | 520 |
APPENDIX 8 BIOLOGICAL TESTS AND METHODS | 520 |
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8.1 Abnormal Toxicity Test | 521 |
8.2 Pyrogen Test | 521 |
8.5 Test for Bacterial Endotoxins | 522 |
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APPENDIX 9 STATISTICAL ANALYSIS OF RESULTS OF BIOLOGICAL ASSAYS AND TESTS | 528 |
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APPENDIX 10 MICROBIOLOGICAL TESTS | 615 |
10.1 Sterility Test | 615 |
10.2 Microbial Limit Tests | 621 |
10.4 Microbiological Attributes of Non-sterile Pharmaceutical Products | 637 |
10.5 Limits for Microbial Contamination | 637 |
10.6 Efficacy of Antimicrobial Preservation | 640 |
APPENDIX 11 CONTAINERS | 642 |
11.1 Glass Containers | 642 |
11.2 Plastic Containers | 645 |
11.3 Containers for Human Blood and Blood Components | 654 |
11.4 Sets for the Transfusion of Human Blood and Blood Components | 656 |
APPENDIX 12 STERILIZATION AND STERILITY ASSURANCE | 658 |
APPENDIX 13 INFRARED REFERENCE SPECTRA | 664 |
APPENDIX 14 BIOLOGICAL AND BIOCHEMICAL ASSAYS | 686 |
14.2 Blood and Related Products | 686 |
14.2.1 Biological Assay of Heparin in Coagulation Factors 14.2.2 Test for Prekallikrein Activator 14.2.3 Determination of Hemoglobin Concentration by Hemiglobincyanide Method |
686 686 687 |
14.5 Immunochemical Methods | 688 |
14.6 Nucleic Acid Amplification Techniques | 690 |
APPENDIX 15 ASSAY OF BIOLOGICAL PRODUCTS | 692 |
15.1 Human Blood and Blood Products 692 | |
15.1.1 Determination of ABO Group of Donors 15.1.2 Determination of Rh Group of Donors 15.1.3 Biological Assay of Human Coagulation Factor VIII 15.1.4 Biological Assay of Human Coagulation Factor IX 15.1.5 Biological Assay of Human Coagulation Factor X 15.1.6 Biological Assay of Anti-Rh0 (D) Immunoglobulin 15.1.7 Biological Assay of Human Coagulation Factor II 15.1.8 Biological Assay of Human Coagulation Factor VII 15.1.9 Biological Assay of Human von Willebrand Factor 15.1.10 Test for Anti-D Antibodies in Human Immunoglobulin for Intravenous Administration 15.1.11 Test for Anticomplementary Activity of Immunoglobulin |
692 694 696 697 697 698 701 701 702 704 705 |
15.2 Antisera | 707 |
15.2.7 Biological Assay of Cobra Antivenin | 707 |
15.3 Vaccines | 708 |
15.3.1 Biological Assay of Adsorbed Diphtheria Vaccine 15.3.2 Biological Assay of Adsorbed Pertussis Vaccine 15.3.3 Biological Assay of Adsorbed Tetanus Vaccine |
708 709 710 |