Contents of General Requirements of ChP

228
发表时间:2023-02-08 13:57

中华人民共和国药典

2020 年版

四部

国家药典委员会


中国医药科技出版社


0100 General Requirements for Preparations —P1

0101 Tablets—P1

0102 Injections—P3

0103 Capsules—P6

0104 Granules—P7

0105 Eye Preparations—P8

0106 Nasal Preparations—P10

0107 Suppositories—P11

0108 Pills—P12

0109 Ointments, Creams—P14

0110 Pastes—P14

0111 Preparations for Inhalation—P14

0112 Sprays—P19

0113 Aerosols—P20

0115 Powders—P22

0116 Syrups—P23

0117 Liniments—P24

0118 Paints—P24

0119 Pigments—P24

0120 Tinctures—P25

0123 Oral Solutions, Oral Suspensions, Oral Emulsions—P27

0124 Implants—P28

0125 Pellicles—P28

0126 Ear Preparations—P29

0127 Lotions—P29

0128 Irrigants—P30

0129 Enemas—P30

0181 Mixtures—P31

0182 Troches—P31

0183 Concentrated Decoctions—P31

0184 Glues—P32

0185 Medicinal Wines—P32

0186 Plasters—P33

0187 Medicinal Distillates—P33

0188 Medicinal Teas—P33

0189 Liquid Extracts and Extracts—P34

0200 General Requirements for Other Pharmaceutical Materials —P35

0211Sampling of Crude Drugs and Decoction Pieces—P35

0212 General Principle for Inspection of Crude Drugs and Decoction Pieces—P35

0213 The Processing of Crude Drugs —P37

0251General Requirements for Pharmaceutical Excipients —P39

0261Water for Pharmaceutical Purposes and Decoction Pieces—P40

0291General Requirements for National Pharmaceutical Reference Standards and Decoction Pieces—P41

0300—P42

0301 General Identification Tests—P42

0400 Spectrometry—P44

0401 Ultraviolet-Visible Spectrophotometry—P46

0402 Infrared Spectrophotometry—P47

0405 Fluorescence Spectrophotometry—P48

0406 Atomic Absorption Spectrophotometry—P49

0407 Flame Photometry —P50

0411 Inductively Coupled Plasma-Atomic Emission Spectrometry —P51

0412 Inductively Coupled Plasma-Mass Spectrometry—P51

0421 Raman Spectrometry—P56

0431 Mass Spectrometry—P60

0441Nuclear Magnetic Resonance Spectrometry—P63

0451 X-Ray Diffraction—P66

0461 X-Ray Fluorescence Spectrometry—P68

0500 Chromatography—P68

0501 Paper Chromatography—P69

0502 Thin-Layer Chromatography—P70

0511 Column Chromatography—P72

0512 High Performance Liquid Chromatography—P72

0513 Ion Chromatography—P77

0514 Size-Exclusion Chromatography —P79

0521 Gas Chromatography—P80

0531 Supercritical Fluid Chromatography—P81

0532 Liquid Chromatography at Critical Condition—P82

0541 Electrophoresis—P83

0542 Capillary Electrophoresis —P93

0600 Determination of Physical Constant—P95

0601 Determination of Relative Density—P95

0611 Determination of Distilling Range—P96

0612 Determination of Melting Point—P97

0613 Determination of Congealing Point—P98

0621 Determination of Optical Rotation —P99

0622 Determination of Refractive Index—P99

0631 Determination of pH Value—P100

0632 Determination of Osmolality—P101

0633 Determination of Viscosity—P102

0661 Thermal Analysis—P105

0681 Determination of Conductivity of Water for Pharmaceutical Use—P107

0682 Determination of Total Organic Carbon in Water for Pharmaceutical Use—P109

0700 Other Determination Methods—P110

0701 Potentiometric Titration and Dead-Stop Titration—P110

0702 Non-Aqueous Titration—P111

0703 Oxygen-Flask Combustion—P112

0704 Determination of Nitrogen—P112

0711 Determination of Ethanol—P113

0712 Determination of Methoxy, Ethoxy and Hydroxypropoxy Groups—P115

0713 Tests of Fats and Fatty Oils—P117

0721 Vitamin A Assay—P122

0722 Vitamin D Assay—P124

0731 Determination of Protein Content—P126

0800 Limit Tests—P129

0801 Limit Test for Chlorides—P129

0802 Limit Test for Sulfates—P129

0803 Limit Test for Sulfides—P129

0804 Limit Test for Selenium—P130

0805 Limit Test for Fluorides—P130

0806 Determination of Cyanide—P130

0807 Limit Test for Iron—P131

0808 Limit Test for Ammonium—P131

0821 Limit Test for Heavy Metals—P131

0822 Limit Test for Arsenic—P132

0831 Determination of Loss on Drying—P133

0832 Determination of Water—P133

0841 Determination of Residue on Ignition—P136

0842 Limit Test for Readily Carbonizable Substances—P136

0861 Determination of Residual Solvents—P136

0871 Determination of Methanol—P142

0872 Acetic Acid in Synthetic Peptides—P142

0873 Determination of 2-Ethylhexanoic Acid—P142

0900 Tests for Special Properties or Other Indicators—P143

0901 Colour of Solution—P143

0902 Clarity of Solution—P 145

0903 Test for Particulate Matter in Injections—P 146

0904 Test for Visible Particles —P 149

0921 Determination of Disintegration —P 151

0922 Disintegration Test for Suppositories and Vaginal Tablets—P 153

0923 Test for Tablet Friability—P 154

0931 Dissolution and Drug Release Test—P 155

0941 Test for Content Uniformity—P 161

0942 Minimum Fill—P 161

0951 Preparations For Inhalation :Aerodynamic Assessment of Fine Particles—P 162

0952 Determination of Adhesion—P 167

0981 Crystallinity—P 170

0982 Determination of Particle Size and Particle Size Distribution—P 170

0983 Measurement of Consistency by Penetrometry—P 172

0991 Determination of Specific Surface Area—P 173

0992 Density of Solids—P 175

0993 Bulk Density and Tapped Density—P 176

1000 Molecular Biological Tests—P 179

1001 Polymerase Chain Reaction—P 179

1021 Bacterial DNA Characteristic Sequence Identification Test—P 181

1100 Biological Tests—P 182

1101 Sterility Tests—P 182

1105 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests—P 188

1106 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms—P 193

1107 Microbiological Acceptance Criteria of Nonsterile Pharmaceutical Products—P 198

1108 Microbiological Examination Methods of Prepared Slices of Chinese Crude Drug

—P 200

1121 Antimicrobial Effectiveness Testing—P 204

1141 Test for Abnormal Toxicity—P 207

1142 Test for Pyrogens—P 207

1143 Test for Bacterial Endotoxin—P 208

1144 Test for Vasopressor Substance—P 211

1145 Test for Depressor Substances—P 212

1146 Test for Histamine —P 212

1147 Test for Allergen —P 213

1148 Test for Hemolysis and Agglomeration—P 213

1200 Biological Activity Assays—P 214

1201 Microbiological Assay of Antibiotics—P 214

1202 Preparation of Penicillinase and Determination of Its Activity —P.220

1205 Biological Assay of Vasopressin—P 221

1206 Determination of Cytochrome C Activity—P 221

1207 Assay of Hyaluronidase—P 221

1208 Biological Assay of Heparin—P 222

1209 Biological Assay of Chorionic Gonadotrophin—P 224

1210 Biological Assay of Oxytocin—P 224

1211 Biological Assay of Insulin—P 225

1212 Test for the Prolongation Effect of Protamine Zinc Insulin —P 225

1213 Biological Assay of Protamine Sulfate—P 226

1214 Biological Assay of Digitalis —P 227

1215 Toxicity Test of Sodium Stibogluconate—P 227

1216 Biological Assay of Follicle Stimulating Hormone—P 227

1217 Biological Assay of Luteinising Hormone—P 228

1218 Biological Assay of Calcitonin—P 228

1219 Biological Assay of Growth Hormone—P 229

1401 The Test of Radiopharmaceutical Preparations—P 229

1421 Methods of Sterilization—P 236

1431 Statistical Methods for Biological Assays—P 239

2000 Special Methods for Traditional Chinease Medicines—P 265

2001Microscopical Identification—P 265

2101 Determination of Swelling Capacity—P 266

2102 Determination of Plaster Softening Point—P 267

2202 Determination of Tannins—P 267

2203 Determination of Cineol —P 268

2204 Determination of Volatile Oil —P 268

2301 Determination of Foreign Matter—P 269

2302 Determination of Ash—P 269

2303 Limit Tests of Rancidity—P 269

2321 Determination of Lead (Pb), Cadmium(Cd), Arsenic(As); Mercury(Hg) and Copper(Cu) —P 270

2322 Determination of Mercury and Arsenic Speciation and Their Valence States—P 272

2331 Determination of Residue of Sulfur Dioxide—P 274

2341 Determination of Pesticide Residues—P 275

2351 Determination of Mycotoxins—P 302

2400 Determination of Materials in Injections—P 307

3000 Special Mothods for Biological Products—P 309

3100 Determination of Content —P 309

3101 Determination of Total Solid —P 309

3102 Determination of Sialic Acid Content (Resorcinol Colorimetry) —P 309

3103 Determination of Phosphorus Content—P 310

3104 Determination of Ammonium Sulfate Content—P 310

3105 Determination of Sodium Bisulfite Content—P 310

3106 Determination of Aluminium Hydroxide (or Aluminium Phosphate) Content —P 311

3107 Determination of Sodium Chloride Content—P 312

3108 Determination of Citrate Content—P 312

3109 Determination of Potassium Content—P 313

3110 Determination of Sodium Content—P 313

3111 Determination of Sodium Caprylate—P 313

3112 Determination of Acetyltryptophan—P 314

3113 Determination of Phenol Content —P 314

3114 Determination of Meta Cresol Content —P 315

3115 Determination of Thimerosal Content —P 315

3116 Determination of Methyl Parahydroxybenzoate and Propyl p-Hydroxybenzoate Contents—P 316

3117 Determination of O-Acetyl Content—P 317

3118 Determination of Adipic Dihydrazide Content—P 317

3119 Determination of Content in High Molecular Weight Conjugate—P 318

3120 Determination of Saccharide and Sugar Alcohol Contents in Human Blood Products —P 318

3121 Determination of Polymer Content in Human Albumin—P 319

3122 Determination of IgG Monomer and Dimer in Human Immunoglobulins—P 319

3123 Determination of Glycine Content in Human Immunoglobulin —P 320

3124 Determination of Protein Content in Recombinant Human Granulocyte Colony-stimulating Factor—P 321

3125 Determination of Free Histamine Phosphate in Human Histamine Immunoglobulin—P 321

3126 Determination of IgG Content (UItraviolet-visible Spectrophotometry) —P 322

3127 Determination of Molecular Size Heterogeneities in Monoclonal Antibodies—P 322

3128 Determination of Molecular Size Distribution in lmmunosera—P 323

3129 Determination of Monoclonal Antibody Charge Variants—P 324

3130 Determination of N-glycan Profile for Monoclonal Antibodies—P 325

3200 Determination of Chemical Residues—P 329

3201 Determination of Residual Ethanol Content (Conway Diffusion Method) —P 329

3202 Determination of Residual Polyethylene Glycol Content—P 329

3203 Determination of Residual Polysorbate 80 Content—P 330

3204 Determination of Residual Glutaraldehyde Content —P 330

3205 Determination of Residual Tributyl-phosphate Content—P 331

3206 Determination of Residual Carbodimide Content —P 331

3207 Determination of Free Formaldehyde Content—P 331

3208 Determination of Residual Aluminium Content in Human Albumin —P 333

3209 Determination of Residual Hydroxylamine—P 334

3300 Microbial Test—P 334

3301 Test for Mycoplasma—P 334

3302 Test for Adventitious Viruses—P 336

3303 Test for Murine Viruses —P 337

3304 Test for Nucleotide Sequence of SV40 —P 340

3305 Neurovirulence Test in Monkeys—P 341

3306 Requirements for Virus Nucleic Acid Testing on Source Plasma used for Blood Products —P 342

3307 Neurovirulence Test of Yellow Fever Vaccine Monkeys—P 343

3308 Fluorescence Quantitative PCR (QPCR)Test for Avian Viruses —P 344

3400 Biological Assay—P 345

3401 Immunoblot—P 345

3402 Immunodot—P 346

3403 Double Immunodiffusion—P 346

3404 Immunoelectrophoresis—P 346

3405 Peptide Mapping Method—P 347

3406 Test for Losing Rate of Plasmid—P 349

3407 Determination of Residual Extraneous DNA—P 350

3408 1Determination of Residual Antibiotics (Culture Method) —P 353

3409 Determination of Prekallikrein Activator Content —P 354

3410 Test for Anticomplement Activity —P 354

3411 Determination of Residual Bovine Serum Albumin—P 356

3412 Determination of Residual Host Bacterial Protein (E. coli) —P 356

3413 Determination of Residual Host Bacterial Protein(Pseudomonas) —P 357

3414 Determination of Residual Host Yeast Protein—P 358

3415 Test for Blood Group A-Like Substance(Hemagglutination Inhibition Assay) —P 359

3416 Determination of Residual Murine IgG—P 359

3417 Identity Test for Acellular Pertussis Vaccines (Enzyme Linked Immunosorbent Assay) —P 360

3418 Identity Test for Antitoxin and Antiserum(Enzyme Linked Immunosorbent Assay) —P 361

3419 Determination of Molecular Size Distribution for Group A Meningococcal Polysaccharide—P 361

3420 Determination of Molecular Size Distribution for Typhoid Vi Polysaccharide —P 362

3421 Determination of Polysaccharide Content in Haemophilus influenzae Type b Conjugate Vaccine—P 362

3422 Test for Human Thrombin Activity—P 363

3423 Test for Activated Coagulation Factor Activity—P 363

3424Determination of Heparin Content(Coagulation Method) —P 364

3425 Test for Anti-A and Anti-B Hemagglutinins (Indirect Anti-human Globulin Test) —P 364

3426 Determination of Human Erythrocyte Antibody(Microtitre Plate Method) —P 365

3427 Determination of Human Platelet Antibody—P 365

3428Determination of Residual IgA for Human Immunoglobulins—P 366

3429 Immunochemical Methods—P 367

3500 Biological Activity/Potency Test —P 375

3501 In vitro Test for Relative Potency of Recombinant Hepatitis B Vaccine (Yeast) —P 375

3502 In vitro Test for Relative Potency of Hepatitis A Vaccine, Inactivated—P 375

3503 Potency Test on Rabies Vaccine for Human Use—P 376

3504 Potency Test on Adsorbed Tetanus Vaccine—P 377

3505 Potency Test on Adsorbed Diphtheria Vaccine—P 377

3506 Determination of Flocculation Unit of Toxoid—P 378

3507 Potency Test on Diphtheria Antitoxin (Rabbit2 Skin Test) —P 379

3508 Potency Test on Tetanus Antitoxin (Mouse Bioassay) —P 379

3509 Potency Test for Gas-gangrene Antitoxins (Mouse Bioassay) —P 380

3510 Potency Test for Botulinum Antitoxin (Mouse Bioassay) —P 381

3511 Potency Test for Antivenins (Mouse Bioassay)—P 382

3512 Potency Test for Rabies Immunoglobulin—P 383

3513 Potency Test for Diphtheria Antitoxin in Human Immunoglobulin—P 385

3514 Test for Fe Function in Human lmmunoglobulin—P 386

3515 Potency Test for Anti-human T Lymphocyte Immunoglobulin (E Rosette Formation-inhibition Test—P 387

3516 Potency Test for Anti-human T Lymphocyte Immunoglobulin (Lymphocytotoxicity Test)—P 387

3517 Potency Test for Human Coagulation Factor Ⅱ (One-step Method) —P 388

3518 Potency Test for Human Coagulation Factor Ⅶ (One-step Method) —P 389

3519 Potency Test for Human Coagulation Factor IX (One-step Method) —P 389

3520 Potency Test for Human Coagulation Factor X(One-step Method )—P 388

3521 Potency Test for Human Coagulation Factor VII(One-step Method )—P 390

3522 In vivo Test for Biological Activity of Human Erythropoietin (Reticulocyte Method) —P 390

3523 Biological Activity Test on Interferon —P 391

3524 Biological Activity Test for Human Interleukin-2(CTLL-2Cell/MTT Colorimetric Method) —P 392

3525 Biological Activity Test for Human Granulocyte Colony-stimulating Factor(NFS-60 Cell Strain/MTT Colorimetric Method) —P 393

3526 Biological Activity Test on Human Granulocyte/Macrophage Colony-stimulating Factor(TF-1 Cell/MTT Colorimetric Method) —P 393

3527 Biological Activity Test for Bovine Basic Fibroblast Growth Factor/(Cell Proliferation/MTT Colorimetric Method) —P 394

3528 Biological Activity Test for Epidermal Growth Factor(Cell Proliferation/MTT Colorimetric Method) —P 395

3530 Biological Activity Test for Mouse-Nerve Growth Factor —P 395

3531Biological Activity Test for Nimotuzumab Injection—P 396

3532 Biological Activity Test for Human Interledkin-11 (Interleukin B9-11 Cell/MTT Colorimetric Method ) —P 397

3533 Potency Test for Botulinum Toxin Type A (Method of Parallel Lines) —P 398

3534 Potency Test for Poliomyelitis Vaccine,Inactivated, Sabin Strain(The Rat Method) —P 398

3535 Potency Test for Conbercept—P 399

3600 Specific Biologica Raw Materials/Animals—P 401

3601 Requirements for Animals Used for the Production and Quality Control of Biologics—P 401

3603 Recombinant Trypsin—P 403

3604 Test Requirements for Newborn Calf Serum—P 404

3605 Culture Media for Biochemical Reactions of Bacteria and Test Method—P 406

3650 Aluminium Hydroxide Adjuvant—P 409

3800 Reagents, Test Solutions, Standard Substances—P 411

3801 List of National Standards for Biologics—P 411

4000 Test for Drug Packaging Materials and Containers—P 414

4001 Test for Hydrolytic Resistance of Glass Grains at 121℃—P 414

4002 Determination of Infrared Spectra of Packaging Materials —P 415

4003 Test for Internal Stress Examination of Glass Containers—P 415

4004 Test for Peel Strength—P 416

4005 Test for Tensile Properties—P 417

4006 Test for Hydrolytic Resistance of Inner Surface—P 418

4007 Determination of Gas Permeance—P 419

4008 Test for Heat Seal Strength—P 421

4009 Determination of Boron Trioxide—P 421

4010 Determination of Water Vapor Transmission—P 422

4011 Test for Acute Systemic Toxicity of Packaging Materials for Pharmaceutical Use—P 425

4012 Determination of Density of Packaging Materials for Pharmaceutical Use —P 426

4013 Hemolysis Test of Packaging Materials for Pharmaceutical Use—P 427

4014 Test for Cytotoxicity of Packaging Materials for Pharmaceutical Use—P 427

4015 Test for Penetrability of Closures and Seals for Parenteral Preparations—P 429

4016 Test for Fragmentation of Closures and Seals for Parenteral Preparations—P 431

8000 Reagents and Reference Substance—P 434

8001 Reagents—P 434

8002 Test Solutions—P 455

8003 Test Papers—P 462

8004 Buffer Solutions—P 463

8005 Indicator Solutions—P 465

8006 Volumetric Solutions—P 467

8061 Reference Standards, Reference Drugs and Reference Extractives—P 472

8062 Reference Standards—P 480



Guidelines.

9000 Guidelines—P 489

9001 Guideline for the Stability Testing of Drug Substances and Preparations—P 489

9011 Guideline for in vivo Bioavailability and Bioequivalence Studies for Drug Preparations—P 493

9012 Guideline for Validation of Quantitative Analytical Method of Biological Samples—P 499

9013 Guideline for Sustained, Controlled and Delayed Release Preparations—P 505

9014 Guideline for Microparticle Preparations—P 508

9015 Guideline for Studies and Quality Control of Drug Polymorphism—P 510

9099 Guideline for Verification of Analytical Method—P 513

9100 Guideline for Transfer of Analytical Method—P 514

9101 Guideline for Validation of Analytical Method—P 515

9102 Guideline for the Analysis of Impurities in Drugs—P 519

9103 Guideline for Hygroscopicity—P 521

9104 Guideline for Near-infrared (NIR) Spectrophotometry—P 522

9105 Guideline for Bioactive Assays of Traditional Chinese Medicine—P 524

9106 Guideline for Pharmaceutical Evaluation Based on Microarrays—P 525

9107 Guideline for Molecular DNA Barcoding of Chinese Materia Medica—P 527

9108 Guideline for DNA Sequencing Technology—P 529

9109 Guideline for the Establishment of Standard Nucleic Acid Sequences—P 530

9201 Guideline for Validation of Alternative Microbiological Methods for Pharmaceutical Products—P 532

9202 Guideline for Microbiological Examination of Non-sterile Products—P 534

9203 Guideline for Quality Management of Microbiology Laboratory for Pharmaceutical Products—P 535

9204 Guideline for Microbial Characterization, Identification, and Strain Typing—P 541

9205 Guideline for Microbiological Monitoring and Control of Clean Rooms for Pharmaceutical Products—P 544

9206 Guideline for Validation and Application of Isolator Systems for Sterility Test—P 548

9207 Guideline for Biological Indicators of sterilization —P 552

9208 Guideline for Resistance Tests of Biological Indicators —P 553

9251 Guideline for Bacterial Endotoxin Test —P 555

9301 Guideline for Application of Safety Tests for Injections—P 557

9302 Guideline for Establishment of Limit for Harmful Residue of Traditional Chinese Medicine—P 561

9303 Guideline for Determination of Pigments—P 563

9304 Guideline for Determination of Aluminium(Al), Chromium(Cr),Iron(Fe)and Barium(Ba)   in Traditional Chinese Medicine—P 566

9305 Guideline for Determination of Mycotoxins in Traditional Chinese Medicine—P 566

9306 Guideline for Genotoxic Impurities Control—P 569

9401 Guideline for Validation for Biological Activity/Potency Assay of Biological Products—P 572

9402 Guideline for Stability Test of Biological Products —P 577

9501 Guideline for the Quality Control of Positron Emission Tomographic Radiopharmaceutical Preparation —P 579

9502 Guideline for the Quality Control of Technetitum [99m Tc]Radiopharmaceutical Preparations—P 580

9601 Guideline for Functionality related Characteristics of Pharmaceutical Excipients—P 581

9602 Guideline for the Animal- derived Pharmaceutical Excipients—P 589

9603 Guideline for Quality Control of Pre-mixed and Co-processed Pharmaceutical Excipients—P 591

9621 Guideline for General Requirements for Drug Packaging Materials and Containers—P 592

9622 Guideline for Pharmaceutical Glass Materials and Containers—P 593

9901 Guideline for Preparation of Pharmaceutical Standard Substances of China—P 595