ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public Health
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CONTENT
GENERAL NOTICES
MONOGRAPHS
APPENDICES
TP SUPPLEMENT 2020
TP SUPPLEMENT 2024
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CONTENT
CONTENT
PREFACE
INTRODUCTION
DEDICATION
THE THAI PHARMACOPOEIA COMMITTEE AND SUBCOMMITTEES
THE THAI PHARMACOPOEIA COMMITTEE (2003 - 2011)
GENERAL NOTICES
MONOGRAPHS
A-E
ACYCLOVIR
ACYCLOVIR TABLETS
AMOXICILLIN
AMOXICILLIN CAPSULES
AMOXICILLIN FOR ORAL SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
AMPICILLIN SODIUM
AMPICILLIN SODIUM FOR INJECTION
ARTESUNATE
ARTESUNATE TABLETS
CEFACLOR
CEFACLOR CAPSULES
CEFACLOR FOR ORAL SUSPENSION
CEFADROXIL
CEFADROXIL CAPSULES
CEFADROXIL FOR ORAL SUSPENSION
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM FOR INJECTION
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM FOR INJECTION
CEFOXITIN SODIUM
CEFOXITIN SODIUM FOR INJECTION
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM FOR INJECTION
CEFUROXIME AXETIL
CEFUROXIME AXETIL TABLETS
CEFUROXIME SODIUM
CEFUROXIME SODIUM FOR INJECTION
CEPHALEXIN
CEPHALEXIN CAPSULES
CEPHALEXIN FOR ORAL SUSPENSION
CEPHALEXIN TABLETS
CHLORAMPHENICOL
CHLORAMPHENICOL CAPSULES
CHLORAMPHENICOL EAR DROPS
CHLORAMPHENICOL EYE DROPS
CHLORAMPHENICOL EYE OINTMENT
CHLORAMPHENICOL SODIUM SUCCINATE
CHLORAMPHENICOL SODIUM SUCCINATE FOR INJECTION
CHLOROQUINE PHOSPHATE
CHLOROQUINE PHOSPHATE TABLETS
CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE TABLETS
CLAVULANATE POTASSIUM
CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE CAPSULES
CLOFAZIMINE
CLOFAZIMINE CAPSULES
CLOTRIMAZOLE
CLOTRIMAZOLE CREAM
CLOTRIMAZOLE VAGINAL TABLETS
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM CAPSULES
CLOXACILLIN SODIUM FOR INJECTION
CLOXACILLIN SODIUM FOR ORAL SOLUTION
DAPSONE
DAPSONE TABLETS
DOMPERIDONE
DOMPERIDONE ORAL SUSPENSION
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE CAPSULES
ERYTHROMYCIN
ERYTHROMYCIN DELAYED-RELEASE TABLETS
ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE FOR ORAL SUSPENSION
ERYTHROMYCIN ETHYLSUCCINATE TABLETS
ERYTHROMYCIN STEARATE
ERYTHROMYCIN STEARATE TABLETS
F-I
GENTAMICIN SULFATE
GENTAMICIN SULFATE CREAM
GENTAMICIN SULFATE EYE DROPS
GENTAMICIN SULFATE INJECTION
GENTAMICIN SULFATE OINTMENT
GRISEOFULVIN
GRISEOFULVIN TABLETS
HYDROCORTISONE ACETATE
HYDROCORTISONE ACETATE AND NEOMYCIN SULFATE EYE OINTMENT
IDOXURIDINE
IDOXURIDINE EYE DROPS
J-N
LINCOMYCIN HYDROCHLORIDE
LINCOMYCIN HYDROCHLORIDE INJECTION
METRONIDAZOLE
METRONIDAZOLE TABLETS
MICONAZOLE NITRATE
MICONAZOLE NITRATE CREAM
NALIDIXIC ACID
NALIDIXIC ACID TABLETS
NEOMYCIN SULFATE
NEOMYCIN SULFATE TABLETS
NORFLOXACIN
NORFLOXACIN TABLETS
NYSTATIN
NYSTATIN ORAL SUSPENSION
NYSTATIN TABLETS
O-R
OXYTETRACYCLINE HYDROCHLORIDE
OXYTETRACYCLINE HYDROCHLORIDE CAPSULES
PENICILLIN V POTASSIUM
PENICILLIN V POTASSIUM FOR ORAL SOLUTION
PENICILLIN V POTASSIUM TABLETS
PURIFIED WATER
PURIFIED WATER IN CONTAINERS
PURIFIED WATER, STERILE
PYRAZINAMIDE
PYRAZINAMIDE TABLETS
QUININE SULFATE
QUININE SULFATE TABLETS
S-V
STREPTOMYCIN SULFATE
STREPTOMYCIN SULFATE INJECTION
SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS
TETRACYCLINE HYDROCHLORIDE
TETRACYCLINE HYDROCHLORIDE CAPSULES
TETRACYCLINE HYDROCHLORIDE TABLETS
TOBRAMYCIN
TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE INJECTION
TOLPERISONE HYDROCHLORIDE
TOLPERISONE HYDROCHLORIDE TABLETS
TRIMETHOPRIM
VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE FOR INJECTION
W-Z
WATER FOR INJECTION
WATER FOR INJECTION, BACTERIOSTATIC
WATER FOR INJECTION, STERILE
WATER FOR IRRIGATION, STERILE
WATER FOR INHALATION, STERILE
WATER FOR HEMODIALYSIS
Biological Products
GENERAL INFORMATION
GENERAL TESTING METHODS FOR BIOLOGICAL PRODUCTS
HUMAN BLOOD AND BLOOD PRODUCTS
ANTICOAGULANT AND PRESERVATIVE SOLUTIONS FOR HUMAN BLOOD
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION
BLOOD, WHOLE
RED CELL CONCENTRATE
PLATELET CONCENTRATE
FRESH FROZEN PLASMA
PLASMA FOR FRACTIONATION
ALBUMIN SOLUTION
ANTITHROMBIN III CONCENTRATE
DRIED FACTOR VII FRACTION
DRIED FACTOR VIII FRACTION
DRIED FACTOR VIII (rDNA)
FACTOR VIII, CRYOPRECIPITATED
DRIED FACTOR IX FRACTION
DRIED PROTHROMBIN COMPLEX
FIBRIN SEALANT KIT
IMMUNOGLOBULIN
HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION
ANTI-Rh0 (D) IMMUNOGLOBULIN
ANTI-Rh0 (D) IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION
HEPATITIS B IMMUNOGLOBULIN
RABIES IMMUNOGLOBULIN
TETANUS IMMUNOGLOBULIN
VARICELLA IMMUNOGLOBULIN
ANTISERA
ANTISERA
BOTULINUM ANTITOXIN
DIPHTHERIA ANTITOXIN
TETANUS ANTITOXIN
RABIES ANTISERUM
COBRA ANTIVENIN
KING COBRA ANTIVENIN
BANDED KRAIT ANTIVENIN
MALAYAN KRAIT ANTIVENIN
GREEN PIT VIPER ANTIVENIN
MALAYAN PIT VIPER ANTIVENIN
RUSSELL’S VIPER ANTIVENIN
HEMATOTOXIC POLYVALENT ANTIVENIN (GREEN PIT VIPER, MALAYAN PIT VIPER, AND RUSSELL’S VIPER ANTIVENIN)
NEUROTOXIC POLYVALENT ANTIVENIN (COBRA, KING COBRA, BANDED KRAIT AND MALAYAN KRAIT ANTIVENIN)
VACCINES
VACCINES
BACILLUS CALMETTE-GUÉRIN VACCINE, FREEZE-DRIED
PERCUTANEOUS BACILLUS CALMETTEGUÉRIN VACCINE
CHOLERA VACCINE
DIPHTHERIA VACCINE, ADSORBED
HAEMOPHILUS TYPE B CONJUGATE VACCINE
HEPATITIS A VACCINE, INACTIVATED
HEPATITIS B VACCINE, RECOMBINANT
HOUSE DUST MITE ALLERGEN VACCINE
INFLUENZA VACCINE, INACTIVATED (WHOLE VIRION)
INFLUENZA VACCINE, INACTIVATED (SPLIT VIRION)
INFLUENZA VACCINE, INACTIVATED (SURFACE ANTIGEN)
INFLUENZA VACCINE, INACTIVATED (SURFACE ANTIGEN, VIROSOME)
JAPANESE ENCEPHALITIS VACCINE, INACTIVATED
MENINGOCOCCAL POLYSACCHARIDE VACCINE
MEASLES VACCINE, LIVE
MUMPS VACCINE, LIVE
PERTUSSIS VACCINE, ADSORBED
PERTUSSIS VACCINE (ACELLULAR COMPONENT), ADSORBED
PNEUMOCOCCAL POLYSACCHARIDE VACCINE
PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, ADSORBED
POLIOMYELITIS VACCINE, ORAL
POLIOMYELITIS VACCINE, INACTIVATED
RABIES VACCINE, INACTIVATED
RUBELLA VACCINE, LIVE
MEASLES, MUMPS, AND RUBELLA VACCINE, LIVE
TETANUS VACCINE, ADSORBED
DIPHTHERIA AND TETANUS VACCINE, ADSORBED
DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR COMPONENT) VACCINE, ADSORBED
TETANUS AND DIPHTHERIA VACCINE FOR ADULT USE, ADSORBED
DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE, ADSORBED
TYPHOID POLYSACCHARIDE VACCINE
TYPHOID VACCINE, ORAL
VARICELLA VACCINE, LIVE
YELLOW FEVER VACCINE, LIVE
DIAGNOSTIC PREPARATION
APPENDICES
CONTENT OF THE APPENDICES
GENERAL INFORMATION
1.1 REAGENTS(1)
1.1 REAGENTS(2)
1.1 REAGENTS(3)
1.2 VOLUMETRIC SOLUTIONS
1.3 STANDARD SOLUTIONS
1.4 pH INDICATORS
1.5 BUFFER SOLUTIONS
1.6 TEST SOLUTIONS
1.7 MATERIALS FOR CHROMATOGRAPHY
1.8 REFERENCE SUBSTANCE
1.9 VOLUMETRIC APPARATUS
1.10 WEIGHTS AND BALANCES
1.11 POWDER FINENESS AND SIEVES
1.13 NAMES, SYMBOLS AND ATOMIC WEIGHTS OF ELEMENTS
1.14 WEIGHTS AND MEASURES: SI UNITS
1.15 MEDICINE DROPPER
1.16 PHARMACEUTICAL DOSAGE FORMS(1)
1.16 PHARMACEUTICAL DOSAGE FORMS(2)
1.16 PHARMACEUTICAL DOSAGE FORMS(3)
1.17 ESTIMATION OF BODY SURFACE AREA
1.18 ESTIMATION OF LEAN BODY WEIGHT
SPECTROSCOPY
2.1 INFRARED SPECTROPHOTOMETRY
2.2 ULTRAVIOLET AND VISIBLE SPECTROPHOTOMETRY
2.3 ATOMIC SPECTROMETRY: EMISSION AND ABSORPTION
2.4 FLUORESCENCE SPECTROPHOTOMETRY
2.5 TURBIDIMETRY AND NEPHELOMETRY
2.6 RAMAN SPECTROMETRY
2.7 X-RAY FLUORESCENCE SPECTROMETRY
2.8 MASS SPECTROMETRY
2.9 NUCLEAR MAGNETIC RESONANCE SPECTROMETRY
2.10 PLASMA SPECTROCHEMISTRY
CHROMATOGRAPHY AND ELECTROPHORESIS
3.1 THIN-LAYER CHROMATOGRAPHY
3.2 PAPER CHROMATOGRAPHY
3.3 COLUMN CHROMATOGRAPHY
3.4 GAS CHROMATOGRAPHY
3.5 HIGH-PRESSURE LIQUID CHROMATOGRAPHY
3.6 SIZE-EXCLUSION CHROMATOGRAPHY
3.7 ELECTROPHORESIS
3.8 CAPILLARY ELECTROPHORESIS
3.9 CHROMATOGRAPHIC SEPARATION TECHNIQUES
PHYSICAL TESTS
4.1 CLARITY OF SOLUTION
4.2 COLOUR OF SOLUTION
4.3 DETERMINATION OF MELTING RANGE AND MELTING TEMPERATURE
4.4 DETERMINATION OF FREEZING TEMPERATURE
4.5 DETERMINATION OF BOILING RANGE (DISTILLATION RANGE)
4.6 DETERMINATION OF BOILING TEMPERATURE
4.7 DETERMINATION OF REFRACTIVE INDEX
4.8 DETERMINATION OF OPTICAL ROTATION AND SPECIFIC ROTATION
4.9 DETERMINATION OF WEIGHT PER MILLILITRE, SPECIFIC GRAVITY AND RELATIVE DENSITY
4.10 DETERMINATION OF VISCOSITY
4.12 DETERMINATION OF WATER
4.13 DETERMINATION OF INSOLUBLE MATTER
4.14 CRYSTALLINITY
4.15 LOSS ON DRYING
4.16 LOSS ON IGNITION
4.18 X-RAY DIFFRACTION
4.21 DELIVERABLE VOLUME
4.22 DISINTEGRATION TEST FOR SUPPOSITORIES AND PESSARIES
4.23 DISINTEGRATION TEST FOR TABLETS AND CAPSULES
4.24 DISSOLUTION TEST
4.26 MINIMUM FILL
4.27 PARTICULATE MATTER IN INJECTIONS
4.28 UNIFORMITY OF DOSAGE UNITS
4.30 FRIABILITY OF UNCOATED TABLETS
4.31 RESISTANCE TO CRUSHING OF TABLETS
4.32 APPARENT VOLUME
4.33 FLOWABILITY
4.34 POWDER FLOW
4.35 OSMOLALITY
4.36 TOTAL ORGANIC CARBON
4.37 WATER CONDUCTIVITY
4.38 ANALYTICAL FILTRATION BY FILTER PAPER
CHEMICAL TESTS
5.1 GENERAL IDENTIFICATION TESTS
5.2 LIMIT TESTS
5.2 LIMIT TESTS HEAVY METALS IN HERBAL DRUGS AND HERBAL DRUG PREPARATIONS
5.3 DETERMINATION OF SULFATED ASH
5.4 ACID VALUE
5.5 ESTER VALUE
5.6 IODINE VALUE
5.7 SAPONIFICATION VALUE
5.8 UNSAPONIFIABLE MATTER
5.9 HYDROXYL VALUE
5.10 SOLIDIFICATION TEMPERATURE OF FATTY ACIDS
5.11 DETERMINATION OF ESTERS
5.12 PEROXIDE VALUE
5.13 ACID-NEUTRALIZING CAPACITY
5.14 RELATIONSHIP BETWEEN REACTION OF SOLUTION, APPROXIMATE pH AND COLOUR OF CERTAIN INDICATORS
5.15 DETERMINATION OF METHANOL AND 2-PROPANOL
5.16 N,N-DIMETHYLANILINE (DIMETHYLANILINE)
5.17 ORDINARY IMPURITIES Limit
ASSAYS
6.1 NON-AQUEOUS TITRATION
6.2 OXYGEN FLASK COMBUSTION
6.3 COMPLEXOMETRIC TITRATIONS
6.4 POTENTIOMETRY
6.5 DETERMINATION OF ETHANOL
6.6 DETERMINATION OF METHOXYL
6.7 DETERMINATION OF NITROGEN
6.10 BIOLOGICAL ASSAY OF ANTIBIOTICS
6.17 RESIDUAL TITRATIONS
6.22 CONTENT OF ANTIMICROBIAL AGENTS
6.25 POLAROGRAPHY
CRUDE DRUGS
7.1 SAMPLING
7.2 FOREIGN MATTER
7.3 DETERMINATION OF VOLATILE OIL
7.6 ACID-INSOLUBLE ASH
7.7 TOTAL ASH
7.8 DETERMINATION OF CINEOLE
7.9 DETERMINATION OF ALDEHYDES
7.10 SWELLING INDEX
7.11 WATER-SOLUBLE ASH
7.12 EXTRACTIVES
7.13 RESIDUE ON EVAPORATION OF VOLATILE OILS
7.21 TOTAL SOLIDS
7.22H PESTICIDE RESIDUES
BIOLOGICAL TESTS AND METHODS
8.1 ABNORMAL TOXICITY TEST
8.2 PYROGEN TEST
8.5 TEST FOR BACTERIAL ENDOTOXINS
STATISTICAL ANALYSIS OF RESULTS OF BIOLOGICAL ASSAYS AND TESTS
MICROBIOLOGICAL TESTS
10.1 STERILITY TEST
10.2 MICROBIAL LIMIT TESTS
10.4 MICROBIOLOGICAL ATTRIBUTES OF NON-STERILE PHARMACEUTICAL PRODUCTS
10.5 LIMITS FOR MICROBIAL CONTAMINATION
10.6 EFFICACY OF ANTIMICROBIAL PRESERVATION
CONTAINERS
11.1 GLASS CONTAINERS
11.2 PLASTIC CONTAINERS
11.3 CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS
11.4 SETS FOR THE TRANSFUSION OF HUMAN BLOOD AND BLOOD COMPONENTS
STERILIZATION AND STERILITY ASSURANCE
INFRARED REFERENCE SPECTRA
BIOLOGICAL AND BIOCHEMICAL ASSAYS
14.2 BLOOD AND RELATED PRODUCTS
14.5 IMMUNOCHEMICAL METHODS
14.6 NUCLEIC ACID AMPLIFICATION TECHNIQUES
ASSAY OF BIOLOGICAL PRODUCTS
15.1 HUMAN BLOOD AND BLOOD PRODUCTS(1)
15.1 HUMAN BLOOD AND BLOOD PRODUCTS(2)
15.2 ANTISERA
15.3 VACCINES
TP SUPPLEMENT 2020
CONTENT
PREFACE
THE THAI PHARMACOPOEIA COMMITTEE AND SUBCOMMITTEES
INTRODUCTION
GENERAL NOTICE
MONOGRAPH
CANNABIS SUBLINGUAL DROPS
CANNABIS EXTRACT
TP SUPPLEMENT 2024
MONOGRAPHS
ALOE
ANDROGRAPHOLIDE
ANISE
ANISE OIL
ASAFOETIDA
ASAFOETIDA TINCTURE
BELLADONNA LEAF
BELLADONNA LEAF EXTRACT
BELLADONNA LEAF EXTRACT TABLETS
BELLADONNA TINCTURE
CARDAMOM OIL
CARDAMOM OIL TINCTURE, COMPOUND
CAMPHOR, NATURAL
CAMPHOR, RACEMIC
CAMPHOR SPIRIT
CAMPHOR WATER, CONCENTRATED
CATECHU, PALE
CELL-BASED AND GENE THERAPY MEDICINAL PRODUCTS (ATMP)
CHAMOMILE FLOWERS
CINCHONA BARK
COLOPHONY
CORIANDER
CORIANDER OIL
CURCUMIN
DICLOXACILLIN SODIUM
DICLOXACILLIN SODIUM FOR ORAL SUSPENSION
DICLOXACILLIN SODIUM CAPSULES
DIGITALIS LEAF
EUCALYPTUS OIL
FILGRASTIM CONCENTRATED SOLUTION
FILGRASTIM INJECTION
GENE TRANSFER MEDICINAL PRODUCTS FOR HUMAN USE (ATMP)
GENTIAN
GENTIAN TINCTURE
IPECACUANHA
IPECACUANHA LIQUID EXTRACT
IPECACUANHA SYRUP
LAVENDER OIL
LEMON OIL
LEMON OIL, TERPENELESS
LEMON PEEL, DRIED
LEMON SPIRIT
LEMON SYRUP
MYRRH
MYRRH TINCTURE
NUX VOMICA
NUX VOMICA TINCTURE
ORANGE OIL
ORANGE OIL, TERPENELESS
PEPPERMINT LEAF
PEPPERMINT OIL
RHUBARB
ROSE OIL
ROSEMARY OIL
SENEGA ROOT
SENEGA LIQUID EXTRACT
SENEGA TINCTURE
SPEARMINT
SPEARMINT OIL
SQUILL
INDIAN SQUILL
SQUILL TINCTURE
STORAX
STRAMONIUM
STRAMONIUM TINCTURE
SWEET ORANGE OIL
TURPENTINE LINIMENT
UNCARIA HOOK
VALERIAN
PREFACE
TP SUPPLEMENT 2020 •
PREFACE
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