The 2015 Chinese Pharmacopoeia draft

On March 28, 2014, the official website of the State Pharmacopoeia Commission published a notice on the public solicitation of opinions on the “General Amendments to the 2015 Pharmacopoeia” (Draft). According to the notification, the relevant professional committees of the National Pharmacopoeia Commission have completed the research on the preparation and coding of the General Regulations (Appendix), and in January 2014, they passed the pharmacopoeia forum of the State Pharmacopoeia Commission's official website to seek the opinions of all pharmacopoeia members.

The original of the notice is as follows:

Notice on Public Consultation on the General Regulations for the 2015 Pharmacopoeia (Draft)

All relevant units:

According to the requirements of the “2015 edition of the Chinese Pharmacopoeia”, the Committee has organized related professional committees to carry out the integration, addition, and revision of the appendixes of the pharmacopoeia 1, 2 and 3, and separate roll-up work. Through the efforts of the relevant professional committees and the strong cooperation of the relevant units, the research work on the preparation and coding of the General Principles (Appendix) has been completed. In January 2014, the Pharmacopoeia Forum on the website of the Committee of the CPC Committee was invited to seek the opinions of all Pharmacopoeia members. Based on the feedback and suggestions, the overall framework and content of the "China Pharmacopoeia" 2015 General Regulations (Draft) has been formed. The relevant matters are now notified and explained as follows:

I. To further improve the contents of the new edition of the Pharmacopoeia, the Committee will publicly solicit opinions on the overall framework of the Pharmacopoeia (draft) and the general contents of the Pharmacopoeia (draft for solicitation of opinions) on the website in batches. The first batch of drafts for consultation will be publicized. The public notice period is three months.

2. The name of an independent volume is the "2015 Pharmacopoeia General Principles" of the Chinese Pharmacopoeia, including the appendices of the existing Pharmacopoeia 1, 2, and 3, and the texts of varieties of medicinal excipients (see Annex 1 for details).

Third, the general code is intended to be represented by the two-level four-digit Roman numerals “XXYY”, where XX represents the large Roman alphabet (I, II, III, ...) encoded in the existing appendix, and YY represents the English alphabet coded in the existing appendix (A , B, C...). Please refer to Appendix 2 for the details of the old and new appendices/general rules.

4. According to the text integration and experimental studies, the completed general draft of amendments is detailed in Annex 3. Please check the relevant units carefully. If you have any objections, you can fill in the feedback form (see Annex 4.), and attach relevant instructions and/or experimental data. Feedback from the letter or email is provided to the Committee. The unfinished content of the amendment will be announced in the second batch.

5. In order to guarantee the smooth implementation of the 2015 edition of the Chinese Pharmacopoeia, the Committee will publish the general contents of the Pharmacopoeia on the Internet and compile it into a book. In April 2014, the Committee will hold a seminar on the amendments to the new Pharmacopoeia General Regulations. In order to allow the majority of drug standards workers to better understand the preparation of the 2015 edition of the "Chinese Pharmacopoeia", please pay attention.

6. Contacts and Contact Information:

Xu Huayu (Tel: 010–67079521)

Gui Guimin (Tel: 010–67079527)

Hong Xiaoyi (Tel: 010-67079593)

Fax: 010–67152769

E-mail:

annex:

1. "China Pharmacopoeia" 2015 version of the general (draft)

2. Old and new appendices/general rules encoding table

3. The "Chinese Pharmacopoeia" 2015 version of the general catalog and additional content

General 0100 preparations

0101 tablets

0102 Injection

0103 Capsules

0104 Granules

0105 Ophthalmic formulation

0106 nasal preparation

0107 suppository

0108 Ointment

0109 Cream

0110 paste

0111 Inhalation preparation

0112 Spray

0113 aerosol

0114 gel

0115 Powder

0116 drops of pills

0117 Sugar Pills

0118 syrup

0119 tincture

0120 coating agent

0121 coating agent

0122 tincture

0123 patch

0124 plaster

0125 Oral solution Oral suspension Oral emulsion

0126 implant

0127 film agent

0128 ear preparations

0129 lotion

0130 Rinse

0131 enema

0181 pills

0182 mixture

0183 lozenges

0184 Decoction (Ointment)

0185 glue

0186 liquor

0187 stream extracts and extracts

0188 Plaster

0189 Lotion

0190 Tea

0200 other general rules

0211 Medicinal materials and decoction sampling method (unmodified)

0212 General Rules for the Examination of Medicinal Herbs and Herbs (Second Supplement)

0213 General Rules (unmodified)

0251 General rules for medicinal excipients

0261 Pharmaceutical Water

0271 general rules for drug packaging (to be determined)

0272 glass container (to be determined)

0291 General Principles of National Drug Standard Materials (Second Supplement)

0300

0301 General Identification Test (Second Supplement)

0400 spectroscopy

0401 UV-Vis Spectrophotometry

0402 Infrared spectrophotometry

0405 fluorescence spectrophotometry

0406 Atomic Absorption Spectrophotometry

0407 Flame photometry

0411 Inductively Coupled Plasma Atomic Emission Spectrometry

0412 Inductively Coupled Plasma Mass Spectrometry (Updated)

0421 Raman Spectroscopy (New)

0431 Mass Spectrometry

0441 Nuclear Magnetic Resonance Spectroscopy

0451 X-ray diffraction

0500 Chromatography (unmodified)

0501 paper chromatography

0502 TLC

0511 Column Chromatography (unmodified)

0512 HPLC

0513 Ion Chromatography

0514 size exclusion chromatography

0521 Gas Chromatography

0531 Supercritical Fluid Chromatography (to be added)

0532 Critical Point Chromatography (to be added)

0541 electrophoresis

0542 Capillary Electrophoresis

0600 physical constant method

0601 Relative Density Determination (unmodified)

0611 Distillation Method

0612 melting point method

0613 freezing point assay

0621 Polarimetry

0622 refractive index method (unmodified)

0631 pH Measurement

0632 Osmolality assay

0633 viscosity method

0661 Thermal Analysis (Second Supplement)

0681 Determination of conductivity of pharmaceutical water (unmodified)

0682 Total Organic Carbon Determination in Pharmaceutical Water (Unrevised)

0700 Other assays Other Assays

0701 Potentiometric Titration and Perpetual Stop Titration (Unrevised)

0702 Non-aqueous titration

0703 Oxygen cylinder combustion (unmodified)

0704 Nitrogen Measurement

0711 Ethanol assay

0712 Methoxy, Ethoxy, and Hydroxypropyloxy Assays (Unrevised)

0713 Fatty and fatty oil assays (unmodified)

0721 Vitamin A Assay (Not Revised)

0722 Vitamin D Assay (Not Revised)

0731 Protein Content Assay

0800 limited inspection method

0801 Chloride Inspection (Not Revised)

0802 Sulfate Inspection Method (Unrevised)

0803 Sulphide Inspection (Not Revised)

0804 Selenium Test (Not Revised)

0805 Fluoride Inspection Method (Not Revised)

0806 cyanide inspection method

0807 iron salt inspection method (unmodified)

0808 ammonium salt inspection method (second supplement)

0821 Heavy Metal Inspection (First Supplement)

0822 Arsenic Salt Inspection Method (Not Revised)

0831 Loss on drying test

0832 Moisture Determination

0841 Residue on ignition test (second supplement)

0842 easy char method (unmodified)

0861 Residual Solvent Assay (Not Revised)

0871 methanol test method

Determination of Acetic Acid in 0872 Synthetic Peptides (Unrevised)

0873 2-ethylhexanoic acid assay (unmodified)

0900 physical characteristics inspection method

0901 solution color inspection

0902 Clarity Check

0903 Insoluble particle inspection method

0904 visible foreign matter inspection method

0921 disintegration time limit test

0922 fusion time limit test (unmodified)

0923 tablet friability test (unmodified)

Dissolution method 0931 (combined release assay)

0941 Content uniformity test method

0942 minimum loading inspection method

0951 AERODYNAMIC EVALUATION METHOD FOR INHALED POLYMER MICROPARTICLES (ORIGINAL DROPLET DISTRIBUTION MEASUREMENT)

0952 Adhesive strength measurement method

0981 Crystallinity Test (Not Revised)

0982 Particle Size and Size Distribution Determination (First Supplement)

0983 cone penetration test

1000 Molecular Biology Technology

1001 nucleic acid molecular identification method (to be determined)

1100 bioassay

1101 sterility test

1105 Microbial limit test for non-sterile products: Microbiological counting

1106 Microbial limit test for non-sterile products: Control bacteria inspection method

1107 Microbiological limits for non-sterile drugs

1121 Antimicrobial efficacy test (third supplement, new)

1141 Abnormal toxicity test

1142 pyrogen test

1143 bacterial endotoxin test

1144 Boost substance inspection method

1145 Decompression Substance Inspection Method (Unrevised)

1146 Histamine Inspection (Additional)

1147 Allergy Test (Not Revised)

1148 hemolysis and coagulation test

1200 bioactivity assay

1201 antibiotic microbial assay (unmodified)

1202 Penicillinase and its activity assay (unmodified)

1205 vasopressin bioassay

1206 Cytochrome C Activity Assay (unmodified)

1207 Glass Enzyme Assay (Unrevised)

1208 Heparin Bioassay (third supplement)

1209 Choriokinin Bioassay

1210 oxytocin bioassay

1211 Insulin bioassay (unmodified)

1212 Protamine Zinc Insulin Injection Delay Action Test (Unrevised)

1213 Protamine Sulfate Bioassay (unmodified)

1214 Digitalis Bioassay (unmodified)

1215 Sodium Gluconate Sodium Virucity Test (Not Revised)

1216 Follicle Stimulating Hormone Bioassay

1217 Lutein Bioassay

1218 Calcitonin Bioassay

1219 Growth Hormone Bioassay (unmodified)

1401 Radioactive Drug Testing Act (unmodified)

1421 Sterilization (unmodified)

1431 Biometric Statistics Method (Unrevised)

2000 Chinese medicine related examination methods

2001 microscopic identification method (second supplement)

2002 Chinese herbal medicine DNA barcode molecular identification method (new)

2101 Expansion Method (Second Supplement)

2102 Plaster Softening Point Method (Unrevised)

2201 Leachate Assay (unmodified)

2202 Tannin content assay (second supplement)

2203 Determination of olein content (unmodified)

2204 Volatile Oil Assay (Not Revised)

2301 Medicinal materials and decoction impurities inspection method

2302 Ash Determination (unmodified)

2303 rancidity assay (unmodified)

2321 Determination of lead, cadmium, arsenic, mercury, copper (unmodified)

2322 Elemental Forms and Determination of Their Valences (to be added)

2331 Sulfur dioxide residue assay

2341 Determination of Pesticide Residues (Second Supplement + Update)

2351 Aflatoxin Assay (2nd Supplement + Update)

2400 Inspection Method for Related Substances of Traditional Chinese Medicine Injection (Proposed Revision)

2401 Chinese medicine injection protein examination method (to be determined)

2402 Chinese Herbal Injection Qualitative Examination (to be determined)

2403 Chinese medicine injection resin inspection method (to be determined)

2404 Herbal Injection Oxalate Test (to be determined)

2405 Potassium ion test method for traditional Chinese medicine injection (to be determined)

2406 Chinese medicine injection polymer polymer inspection method (to be determined)

3000 bio-product related inspection methods (to be determined)

3100 assay

3101 Total solids determination

3102 Sialic acid assay

3103 Phosphorus assay

3104 ammonium sulfate assay

3105 sodium bisulfite assay

3106 aluminum hydroxide (or aluminum phosphate) assay

3107 Sodium Chloride Assay

3108 citrate ion assay

3109 sodium octanoate assay

3110 acetyl tryptophan assay

3111 phenol assay

3112 m-cresol assay

3113 Thimerosal assay

3114 Determination of Methylparaben and Propylparaben

3115 O-Acetyl assay

3116 Adipic hydrazide content assay

3117 Polymer conjugate content assay

3118 Human blood products sugar and sugar alcohol assay

3119 Human Albumin Multimer Assay

3120 human immunoglobulin products IgG monomer plus dimer assay

3121 Human Immunoglobulin Glycine Content Assay

3122 recombinant human granulocyte stimulating factor protein assay

3123 histamine human immunoglobulin free histamine assay

3124 IgG Content Assay

3200 chemical residue assay

3201 ethanol residue assay

3202 polyethylene glycol residue assay

3203 polysorbate 80 residue assay

3204 glutaraldehyde residue assay

3205 tributyl phosphate residual assay

3206 Carbodiimide (EDAC) Residue Measurement

3207 free formaldehyde assay

3208 human serum albumin aluminum residue assay

3300 microbiological examination

3301 Mycoplasma Test

3302 Exogenous Factor Test

3303 Mouse-borne virus test

3400 bioassay

3401 immunoblotting

3402 immunospot assay

3403 double immunodiffusion assay

3404 immunoelectrophoresis

3405 Peptide Mapping

3406 plasmid loss rate test

3407 SV40 Nucleic Acid Sequence Test

3408 exogenous DNA residue assay

3409 Antibiotic residue test method (culture method)

3410 Kallikrein Activator Assay

3411 Anti-complement activity assay

3412 bovine serum albumin residue assay

3413 E.coli bacterial protein residue assay

3414 Pseudomonas bacteria protein residue assay

3415 Yeast Engineering Protein Residue Protein Assay

3416 class A blood type substance assay

3417 murine IgG residue assay

3418 Acellular Pertussis Vaccine Identification Test (Enzyme Linked Immunosorbent Assay)

3419 Antitoxin, antiserum product identification test (enzyme immunoassay)

Determination of the molecular size of meningococcal polysaccharide 3420 Group A

3421 Typhoid Vi Polysaccharide Molecular Size Assay

Method for determination of polysaccharide content of Haemophilus influenzae 3422 b conjugate vaccine

3423 Human Thrombin Activity Test

3424 activated coagulation factor activity test

3425 Heparin Content Assay

3426 anti-A, anti-B hemagglutinin assay

3427 human erythrocyte antibody assay

3428 Human Platelet Antibody Assay

3429 Monkey Body Neurotoxicity Test

3500 bioactivity/valence assay

3501 Recombinant Hepatitis B Vaccine (Yeast) In Vitro Relative Potency Test

3502 In Vitro Relative Potency Test of Inactivated Hepatitis A Vaccine

3503 human rabies vaccine titer assay

3504 adsorption tetanus vaccine titer assay

3505 adsorption diphtheria vaccine titer assay

3506 toxoid floc unit assay

3507 diphtheria antitoxin titer assay

3508 Tetanus antitoxin titer assay

3509 gas gangrene antitoxin titer assay

3510 botulinum antitoxin titer assay

3511 anti-venom serum titer assay

3512 Rabies immunoglobulin titer assay

3513 diphtheria antibody titer assay in human immunoglobulin

3514 Human Immunoglobulin Fc Section Biological Activity Assay

3515 Anti-human T-cell immunoglobulin titer assay (E rose wreath formation inhibition test)

3516 Anti-human T-cell immunoglobulin titer assay (lymphocyte toxicity test)

3517 human coagulation factor II titer assay

3518 human coagulation factor VII titer assay

3519 human coagulation factor IX titer assay

3520 human coagulation factor X titer assay

3521 human coagulation factor VIII titer assay

3522 Recombinant human erythropoietin in vivo biological activity assay

3523 Interferon Biological Activity Assay

3524 Recombinant Human Interleukin-2 Biological Activity Assay

3525 Recombinant Human Granulocyte Stimulating Factor Biological Activity Assay

3526 Recombinant human granulocyte macrophage stimulating factor biological activity assay

3527 recombinant bovine basic fibroblast growth factor biological activity assay

3528 recombinant human epidermal growth factor biological activity assay

3529 recombinant streptokinase biological activity assay

3600 Specific Biological Raw Materials/Animals

3601 Specific pathogen-free chicken embryo quality testing requirements

3602 Laboratory Animal Microbiological Testing Requirements

3603 Laboratory Animal Parasitology Test Requirements

3604 newborn calf serum test requirements

3611 Bacterial Biochemical Reaction Medium

8000 Reagents and Reference Materials (TBD)

8001 reagent

8002 test solution

8003 test paper

8004 buffer

8005 indicator and indicator liquid

8006 titrant

8061 reference material

9000 guidelines

9001 Guidelines for Stability Testing of Raw Materials and Pharmaceutical Preparations (to be determined)

9011 Guidelines for human bioavailability and bioequivalence testing of pharmaceutical preparations (to be determined)

9012 Guiding Principles for Quantitative Analysis of Biological Samples (TBD)

9013 Sustained Release, Controlled Release and Delayed Release Preparation Guidelines (Unrevised)

9014 Particle Formulation Guidelines (TBD)

9015 injection preparation guidelines (to be added, pending)

9101 Guidelines for Validation of Analysis Methods for Drug Quality Standards

9102 Drug impurity analysis guidelines

9103 Drug Hydration Test Guidelines (Not Revised)

9104 Near-Infrared Spectrophotometry Guidance (Unrevised)

Guidelines for Quality Control Techniques and Methods for 9105 Polymorphic Drugs (New)

9106 Technical Guidelines for Evaluation of Drug Safety and Effectiveness Based on Gene Chip Technology (New)

9201 Guidelines for Validation of Alternative Methods for the Examination of Microorganisms of Drugs (Unrevised)

9202 Microbial Limit Test Application Guidelines

9203 Guidelines for Quality Management of Pharmaceutical Microbiology Laboratory (third supplement)

9204 Guidelines for Microbiological Identification (New)

9205 Guiding Principles for Microbiological Surveillance and Control of Drug Cleaning Laboratories (New)

9206 Segregation System Verification Guidelines for Aseptic Inspection (New)

9301 injection safety inspection application guidelines

9302 Guidelines for the Establishment of Limitations of Hazardous Residues (New)

9401 Guiding Principles for Determination of Biological Activity of Chinese Herbs

9501 Guidelines for Quality Control of Positron-type Radioactive Drugs (Unrevised)

9502锝99mTc Radiopharmaceutical Quality Control Guidelines (Not Revised)

9701 Guiding Principles for the Study of Performance Indicators for Pharmaceutical Excipients (Third Supplement, Proposed Addition)

9901 National Drug Reference Material Preparation Guidelines (Second Supplement)

Schedule Atomic Scale (unmodified)

Schedule of International Unit Conversion Form (to be confirmed)

4. Feedback Draft for Exposure Draft

National Pharmacopoeia Committee

March 28, 2014