cps.docx

1、cpsPummelo peel is the dried unripe or almost ripe exocarp of citrus grandis “tomentosa” or citrus grandis osbeck Chemical identificationShake 0.5 g of the powder with 5 ml of ethanol for 5 minutes and filter. Evaporate the filtrate to dryness, add dropwise antimony trichloride saturation solution i

2、n-chloroform and evaporate again to dryness. A violet-red colour is produced.前言 目录Index 索引Appendices 附录Monographs 正文General noticesThe Pharmacopoeia of the Peoples Republic of China known as Chinese Pharmacopoeia in abbreviation is the official general scientific and technical provisions for drug qu

3、ality control and administration. 中华人民共和国药典，简称中国药典，是国家监督管理药品质量的法定技术标准。Where the Pharmacopoeia is issued for enforcement by the drug regulatory authority of the State Council, the same drug standard of the previous Pharmacopoeia or the original national standard shall not be used. When the Chinese Ph

4、armacopoeia is quoted in this compendium, it denotes the current edition of the Pharmacopoeia of the Peoples Republic of China, except where a specific edition is indicated. General Notices serve as the basic guidelines for the proper interpretation and application of the Chinese Pharmacopoeia in qu

5、ality control. It applies to any articles, appendices and general statements related to quality control of drugs so as to obviate replication in this compendium. The related requirements in General Notices are official in the Pharmacopoeia. The wording “unless specified otherwise” adopted in General

6、 Notices and Appendices indicates that appropriate requirement is admitted in the related monograph wherever the requirement is not conform to that specified in General Notices or Appendices. The drug cited in the Pharmacopoeia should be those admitted in this edition of Pharmacopoeias and comply wi

7、th the requirements of corresponding monographs. The Guidelines stated in Appendices are not considered as official requirements but used as statements in principles applied to the implementation of Pharmacopoeia, monitoring of drug quality, and revising or verifying of drug standards. Titles and Ar

8、rangements 1. The Chinese titles of drugs admitted in the monographs are recommended according to the guideline for the nomenclature of “Chinese Approved Drug Names”. The Chinese title of a drug is adopted as official designation. Unless specified otherwise, the “International Nonproprietary Name” f

9、or pharmaceutical substances (INN) is adopted as the English title. Titles of organic chemical drugs are adopted on the basis of “Guideline for the Nomenclature of Organic Chemistry” published by the Chinese Chemical Society. The selection of main part of its chemical structure is in line with the r

10、ules of the International Union of Pure and Applied Chemistry (IUPAC).2. The chemical structure of the drugs are portrayed according to “Guidelines for Graphic Representation of Chemical Formulae” recommended by the World Health Organization. 3. The monographs are arranged alphabetically on the Engl

11、ish titles of drugs. Monographs for formulated preparations are followed that of drug substance on title in the Pharmacopoeia. Monographs of excipients are listed in separate section. Appendices are arranged into sections including general requirements of formulated preparations, general testing met

12、hods and guidelines. 4. The monograph of each drug substance or different dosage forms is stated with respect to following items: (1) Title of drug substance or dosage forms;(2) Structural formula of organic chemicals;(3) Molecular formula and molecular weight;(4) Sources or chemical name of organic

13、 drugs;(5) Content or potency; (6) Formulary of the dosage form; (7) Processing; (8) Description; (9) Identification; (10) Test; (11) Assay of content or potency; (12) Category; (13) Strength or specification; (14) Storage; (15) Preparation. Specifications 5. Description refers to the appearance, od

14、our, taste, solubility and other physical constants of the drug. (1) Appearance of a drug is the requirements of color and external appearance. (2) Solubility refers to the physical property of a drug substance. Solvents described under the monograph and the relevant solubility behaviors are stated

15、for reference for purification or preparation of solution of a drug substance. Requirement should be stated under the item of test of the drug, if specific quality control is needed for the solubility behavior of the solvent accordingly. Approximate solubilities of drugs are indicated by the followi

16、ng descriptive phrases: Very soluble refers to that 1g (ml) of solute is soluble in less than 1ml of solvent;Freely soluble refers to that 1g (ml) of solute is soluble in 1ml to less than 10ml of solvent;Soluble refers to that 1g (ml) of solute is soluble in 10ml to less than 30ml of solvent;Sparing

17、ly soluble refers to that 1g (ml) of solute is soluble in 30ml to less than 100ml of solvent;Slightly soluble refers to that 1g (ml) of solute is soluble in 100ml to less than 1000ml of solvent;Very slightly soluble refers to that 1g (ml) of solute is soluble in 1000ml to less than 10000 ml of solve

18、nt;Practical insoluble refers to that 1g (ml) of solute is not soluble completely in 10000 ml of solvent. Testing method: unless specified otherwise, weigh out finely powdered sample or measure an amount of liquid sample, place the sample in a certain volume of the solvent at a temperature of 252, s

19、hake strongly for 30 seconds at an interval of 5 minutes. Observe the solubility behavior for 30 minutes. It is considered to be completely soluble, if none of the particles or droplet of the solute is observed. (3) Physical constants or parameters including relative density, distilling range, melti

20、ng point or melting range, congealing point, specific rotation, refractive index, viscosity, specific absorbance, iodine value, saponification value and acid value etc., are useful for tests for identification and give some indication of the drug purity. It is one of the chief criteria for appraisal

21、 and assessment of drug quality. 6. Testing methods given in the identification section are intended to give some of the physical and chemical characteristics of the drug; they are not designed to give a full confirmation of the chemical structure of the drug. 7. Test section under the monograph inc

22、ludes the testing methods and acceptance criteria, uniformity and purity requirements for manufacturing process, which are related to the safety and efficacy of the drug. The specified testing items for impurities are framed from those possibly existed and produced in the drug, which is manufactured

23、 according to the approved manufacturing process and stored under normal condition, and those impurities are needed to be controlled, such as residual solvents and related substances, etc. Receiving to the relevant items may be necessary for where the manufacturing process is changed. The drug subst

24、ance intended for direct use in the preparation of sterile powders for injection should be tested according to the corresponding requirements of the injection and conform with the requirements. Preparations, unless specified otherwise, must comply with the requirements stated under the general requi

25、rements for preparations of the Pharmacopoeia.8. The testing methods specified under the item of Assay are designed to determine the content of active ingredient of drug substance and preparations, Chemical, instrumental or biological methods can usually be adopted. 9. Category refers to main action

26、 and use of the drugs or its classified scientific designation. A drug is not framed using in other category on the basis of experiences in clinical practices. 10. strength of preparations or dosage forms refers to the amount (units of potency), labeled amount (%) or content of active ingredient or

27、ingredients in each ampoule, tablet or other unit container, or preparation. For injections, the expression “1ml: 10mg” indicates that the injection contains 10 mg of active ingredient in 1ml. specification of weight or content may also be specified for the monographs of the preparation in which the

28、 formula is listed or the concentration is indicated. 11. Storage refers to the basic conditions for storage and preservation of a drug. It is stated by the following terms:protected from light refers to that a drug should be kept in light resistant container such as amber colored container, or a co

29、lorless transparent or semitransparent container wrapped with black paper. Well closed refers to that the container should be able to protect the content from extraneous matters or lose of contents on normal handing condition. Tightly closed refers to that the container should be able to protect the

30、 contents from efflorescence, deliquescence, volatilization or interference of extraneous matters. Hermetically sealed or Tightly sealed refers to that the container is sealed on fusion or sealed tightly with suitable material to protect against contamination and from permeability of air and moistur

31、e. Cool place refers to that the storage temperature is not exceeding 20. Cool and dark place refers to that the container is kept in the dark place, protected from light and the ambient temperature is not exceeding 20. Cold place refers to that the container is kept at ambient temperature of 2-10.

32、Normal temperature refers to that the container is kept at ambient temperature of 10-30.12. the drug substances and excipients used in preparations or dosage forms should comply with the requirements stated in the individual monographs of this edition of Pharmacopoeia: for those not admitted in this edition of Pharmacopoeia their specifications should be established, which should comply with requirements for Pharmaceutical use and be approved by the drug regulatory authority of the State Council. Where the same drug substance is used for difference preparations, especial