2.GeneralNotices

1、KP IX 3General Notices2 Ge neral Noticesnot for conformity. color, odor and indicating stan-in the Koreanman ufacture of any official indicate the edible vegetable official mono gra phs. When the manufacture of any offi-etha nolrate of abso rp-1. This is En glish vers ion of the Korea n P harmaco- p

2、 oeia Ninth Editi on, which may be abbreviated as KP IX or KP 9.2. Drugs of the Korea n P harmac opo eia are those sp ecified in the official monographs exce ping Quasi drugs. The official names in the Pharmacopoeia are the title names and the commonly used names adopted in the official monographs.

3、In the official monograp hs, the titles are accompanied with chemical names or Latin names as the occasi on dema nds. Gen eral requireme nts for drugs are similarly app lied to quasi drugs. In the case of a drug in fine granules which is recog- ni zed as po wder in the Gen eral Requireme nts for Pha

4、rmaceutical Preparations, Powder may read Fine Gran ules.3. Drugs are to be tested accord ing to the p rovisi onsgive n in the p ert inent Official Mono gra phs, General Notices, General Requirements for Pharmaceutical Prep arati ons, and the pr ovisi ons of General Tests and Assays for their con fo

5、rmity to the Korean Pharmacopoeia. However, the items of Descri pti on exce pting color and storage un der the Packaging and Storage in the official mono- gra phs are give n for in formati on, and should be taken as indicating standard But in the case of Crude drugs, taste of Description are taken a

6、s dard for con formity.4. The names of the drugs listedPharmacopoeia begin with a capital letter in the En glish vers ion.5. When the contents or the p ote ncy in terms of un itsof the active in gredie nts, or the expi rati on date is specified in the official monographs of the Korean P harmac opo e

7、ia, these stateme nts should be show n on the immediate container or wrapping.6. The n ames of drugs or chemicals followed by molecular formulas or constitution formulas in pa- ren thesis ( ) desig nate chemically pure substa nces. Atomic masses adopted in KP IX conform to the table of "Standar

8、d Atomic Weights 2005". Molecular masses are indicated to two decimal p laces roun ded from the third decimals.7. In stati ng the amou nt of content in p harmaceuticalpreparations, the use of an expression "not less than 95.0 % and not more than 105.0 %" , for example, indicates that

9、it is usually prepared so as to contain the labeled amou nt of the chemically pure substanee or one corresponding to it and that it is quantitatively determined in the above ran ge.8. Pharmaceutical excipients are substances contained in prep arati ons which are used to in crease the utility of the

10、prep arati on, to en able man ufacturi ng of drug products easy, to keep product's in tegrity, to imp rove the app eara nee of a formulati on and so on. For these purp oses, suitable excipients such as diluents, stabilizers, preservatives, bufferi ngage nts, corrige nts, sus pending age nts, emu

11、lsifiers, aromatics, solubilizers, coloring agents and viscous agents may be added. The excipients used, however, should be nontoxic, harmless and p harmacologically in active in the amount administered and must not interfere with the therapeutic efficacy or the test of the prep arati ons.9. Vegetab

12、le oils for thepreparation usually oils listed in the starch is called forcial preparation, any kind of Starch listed in the official monographs, unless otherwise specified. Ethanol specified in vol% is prepared by adding Purified Water or Water for Injection to at (or un til) the sp ecified vol%.10

13、. Functions which control the releasingdrug substa nces, lead ing to the modifiedtion or transfer into the body may be added to pharmaceutical preparations for the purpose of con trolli ng the on set and durati on of thera peutic effects an d/or decreas ing adverse or side effects. However, modified

14、 release preparations should meet the corresponding requirements showing prep arati on characteristics such as dissoluti on test etc. which specify the releasing rate, unless otherwise specified. In addition, the functional modificationof releasing rate should be displayed on the insert paper and di

15、rect container or package of the preparation, unless otherwise sp ecified.11. Immediate-release and modified-release preparations exist in oral dosage forms which show different release characteristics, respectively. Immediate-release dosage forms are preparations showing a release of drug substance

16、s, which is not inten ti on ally modified and gen erally dependent on the intrinsic physicochemical properties of the drug substances. Modified-release dosage forms are prep arati ons show ing a release of drug substances, which is suitably modified by a specific formulationdesign and/or manufacturi

17、ngmethod. Modified-release dosage forms include en teric-coated and exte nded-release prep arati ons. Enteric-coated preparations are designed to release major drug substances in small intestines rather than stomachs in order to prevent the de- gradati on or deco mp ositi on of drug substa nces in s

18、tomach or to decrease the irrita nt effect of drug substances on stomachs. Enteric-coated preparations are gen erally prep ared by applying en teric films to preparations. Extended-release preparations are designed to control the releasing rate and time of drug substa nces and the release sitesin ga

19、strointestinal tracts in order to decrease the dos ing times an d/or to reduce adverse or side effects. Exte nded-release prep arati ons gen erally prepared using suitable agents that prolong the drug release. Capsules, tablets, powders, gran ules and p ills of oral dosage forms can beKP IX 54 Ge ne

20、ral NoticesUnitsAbbr.UnitsAbbr.metermcen timetercmmillimetermmmicrometerpmnano meternmkilogramkggramgmilligrammgmicrogrampgnano gramngp icogrampgliterLmillilitermLmicroliter止Celsius degree°Csquare centimeter2 cmper cen timetercm-1kil op ascalkPamole p er litermol/LmegahertzMHzsquare millimeter

21、per second2mm /smilli pascal secondmPa sn ewt onNmass p erce nt%mass p arts per millio nppmmassp artsper billi onPPbvolume p erce ntvol%volume p arts per milli onvol ppmmass per volume p erce ntw/v%en dotox inun itEUhydroge nionconcen trati onpH18.Note : "ppm" used in the Nuclear Magn etic

22、 Resonance Sp ectrosc opy (1H) in dicates the chemical shift.principle, by standard by word "unit" indicates thein principle. How- may be used inordinary temp era- lukewarm are de-Sieve No.Names of the po wders which p ass through the resp ective sieve.4 (4750 卩m)Coarse cutt ing6.5 (2800 p

23、m)Medium cutt ing8.6 (2000 pm)Fine cutt ing18 (850 pm)Coarse po wder50 (300 pm)Medium po wder100 (150 pm)Fine po wder200 (75 pm)Very fine po wdercoated with appropriate coating agents, such as sugar, sugar alcohol or high-molecular mass materials to en able the in gesti on easy or to pr eve nt degra

24、dati on of drug substa nces.12. Unl ess otherwise sp ecified, official prep arati ons are p referably stored in the room temp erature.13. The followingabbreviations are used for thep ri ncipal un its.14. The un it used for expr ess ing the p ote ncy of drugis recognized as the quantity of drug. Usua

25、lly, it is expressed by a definite quantity of a definite standard substanee which shows a definite biological activity, and differs accord ing to each drug. The un its are determ in ed, in comparison with each referenee means of biological methods. The used for the articles of this bookun it defi n

26、ed in the Korea n P harmac op oeia.15. The temperature for the tests or the storage isdescribed in specific figures ever, the follow ing expr essi ons stead. Stan dard temp erature, ture, room temperature andfined as 20 °C, 15 25 °C, 1 30 °C and 30 40 °C, respectively. The temper

27、atures of cold water, lukewarm water, warm water and hot water are defi ned as not exceed ing 10°C, 30 40°C, 60 70 °C and about 100 °C, respectively. The term "heated solve nt" or "hot solve nt" means a solve nt heated almost to the boil ingpoint of the solve

28、nt, and the term "warmed solven t" or "warm solve nt" usually means a solve nt heated to a temperature between 60 °C and 70 °C. The term "heat on or in a water bath" indicates, unl ess otherwise sp ecified, heat ing with a boil ing water bath or a steam bath a

29、t about 100°C. Coldextraction and warm extraction are usually performed at temperatures of 15 25 °C and 35 45 °C, res pectively.16. To measure the n umber of drops, a dropping device which delivers 20 drops of purified water weighing 0.90 to 1.10 g at 20 °C should be used.17. The

30、 n ame of a solute followed by the word "soluti on" without in dicati on of the n ame of the solvent means aqueous soluti on.The acidity or alkalinity of a solution, unless otherwise sp ecified, is deter mined by blue or red litmus paper. To indicate these properties more p recisely, pH va

31、lues are used.19. The terms in the followi ng table are used to express the degree of coarseness or fineness of Po wder.20. The concentration of a solution expressed as (1 in 10) means ratios whereby 1 g of a solid or 1 mL of a liquid chemical dissolved in the solve ntwill make the total volume into

32、 10 mL. The liquid mixture indicated as (5:2:1) refers the mixture of the mixture of 5, 2, and 1 volumes of liquids.21. The reagents specified in the General Tests and Assays should be used for the test of drugs, unless otherwise sp ecified, and the water to be usedin the test of drugs should be P u

33、rified Water.22. The term "in vacuum" indicates, unless otherwise sp ecified, a p ressure not exceedi ng 2.0 kPa.23. The term "weigh accurately" means to weigh dow n to the degree of 0.1 mg, 0.01 mg or 0.001mg accord ing to the sen sitivity in the bala nee to be used, and the ter

34、m "weigh exactly" means to weigh to the give n decimal p laces.24. A value of n figures in a test of a drug should be obtained by rounding from a value of (n +1) figures. For example, an expression "not less than 95.0 % and not more than 105.0 %" un der assay means that the conte

35、nts deter mined by assay is between 94.95 % and 105.04 % to meet the re- quireme nt.25. Uni ess otherwise sp ecified, all tests of the drugs should be p erformed at ord inary temp erature and observations of the results should follow immediately after the operations. However, the judgment for a test

36、 which is affected by temperature should be based on the temp erature.The terms "immediately"test of a drug mean thatcondition at standardor "at once" used in the procedure is to be9.performed within 30 seconds after the preceding pr ocedure.In the section under the Des

37、cription, the term "white" is used to indicate white or practically white, and "colorless" denotes colorless or practically colorless. Unless otherwise specified, the test of color carried out by placing 1 g of the solid drug on a sheet of white paper or in a watch glass placed o

38、n white paper. Liquid drug is put into a colorless test tube of 15 mm in side diameter and is observed in front of a white background through a layer of 30 mm. For test of clarity of a liquid drug, the same procedure is app lied with either a black or white backgrou nd. For the observati on of fluor

39、esce nee of a liquid drug, only a black backgrou nd should be used.In the section under the Description, the term "odorless" or "no odor" is used to in dicate odorless or p ractically odorless. Unl ess otherwise specified, the test of odor should be carried out by p lac ing 1 g o

40、f solid drug or 1 mL of the liquid drug in a beaker.In the section under the Description, solubilities are expr essed in the terms in the follow ing table. Unless otherwise specified, solubility means the degree of dissolution of drug, previously powdered in the case of a solid, with in 30 min utes

41、in a solve nt at 20 5 °°±by vigorous shak ing for 30 sec onds each time at 5 min ute in tervals.Descri ptive termAmou nt of solve nt required for dissolving 1 g or 1 mL of soluteVery solubleless tha n 1 mLFreely solublenot less tha n 1 mL and less tha n 10 mLSolublenot less tha n 10 m

42、L and less tha n 30 mLSp ari nglysolublenot less tha n 30 mL and less than 100 mLSlightly solublenot less than 100 mL and less than 1000 mLVery slightly solublenot less than 1000 mL and less than 10000 mLPractically in solublenot less than 10000 mL30. In the test of drug, the descri pti on "dis

43、solve" or "miscible" in dicate that it dissolves in, or mixes with, i n arbitrary prop orti on, the solve nt to form a clear solution or mixture, and the presenee of fibers etc. is not permitted unless in extremely min ute qua ntities.31. Ide ntificati on is the test n ecessary to ide

44、 ntify the drug or the main ingredients of the drug based upon a sp ecific prop erty.32. Purity is for detect ing con tam inants in drugs, andit, as well as other requirements in each official monograph, specifies the purity of the drug usually by limiting the kind and quantity of the contaminants.

45、The contaminants which are considered to be the subject of the test are those sup- po sed to con tam in ate or gen erate duri ng the course of the manufacturing process or storage, and hazardous contaminants such as heavy metals, arsenic, etc. If substitution by foreign sub- sta nces or additi on of

46、 such materials is exp ected, the corres ponding tests are n ecessary.33. The term "constant mass" in drying or ignition, unless otherwise specified, means that the mass differe nee after an additi onal 1 hour of drying orign iti on is not more tha n 0.10 p erce nt of the pre- ced ing mass

47、 of the dried substa nee or ign ited residue. In crude drugs, the differenee is not more tha n 0.25 p erce nt. However, whe nthe differe needoes not exceed 0.5 mg in a chemical balanee, 0.05 mg in a semi-microbalanee, and 0.005 mg in a microbala nee, it is con sidered that the difference is n egligi

48、ble and con sta nt mass has bee n at- tai ned.34. Assay is the test to deter mine the compo siti on, the content of the ingredients, and the potency unit of drug by physical, chemical or biologicalp rocedures.35. The sample qua ntity for assay in dicated with the word "about" means that th

49、e weighed qua ntity of sample may deviate within ±10% of the described amou nt. The word "dry "in resp ect of the sample indicates drying under the same conditions, as described in loss on drying in the official mono gra phs.36. The test methods of the Korean Pharmacopoeia can be rep

50、laced by alter native methods which give better accuracy and precision. However, where a differenee is suspected, only the result obtained by the procedure given in this Pharmacop oeia is effective for the final judgme nt.37. The details of the biological test methods may be changed insofar as they

51、do not affect the essential qualities of the test.38. Crude drugs in the official monographs in elude medici nal p arts obta ined from plants and ani mals, cell inclusions and secretes separated from the orig ins, their extracts, and min erals.39. Crude drugs are usually used in the forms of whole c

52、rude drugs, cut crude drugs or powdered crude drugs. Whole crude drugs are the medic in-al parts or their ingredients prepared by drying and/or simple processes, as specified in the official mono gra phs. Cut crude drugs are small p iec-6 Ge neral Noticeses or small blocks prep ared by cutt ing or c

53、rushing of the whole crude drugs, and also coarse, medium or fine cutting of the crude drugs in whole, and powdered crude drugs are coarse, medium, fine or very finepo wder prep ared fromthe whole crude drugs or cut crude drugs, and unless otherwise specified, are required to conform to the specific

54、ations of the whole crude drugs used as origi nal materials.40. Unl ess otherwise sp ecified, crude drugs are used in dried form. The drying is usually carried out at a temp erature not exceedi ng 60 °G41. Crude drugs are as free as possible from contaminants and other impurities due to molds,

55、insects and other animals and from other foreign matters, in the whole process including harvest, processing, packing and distribution, and are required to be kept in a clea n and hygie nic state.42. The orig in of crude drugs is to serve as the criteria for propriety. Such statement as "other

56、species of the same gen us" and "allied plan ts" or "allied ani mals" in the origi n of crude drugs usuallyindicate plants or animals which may be used as materials for crude drugs containing the same effective con stitue nts.43. The Description in each official monograph of

57、 crude drugs usually covers the crude drug derived from its typi cal origi nal plant or ani mal andin cludes stateme nts of characteristic prop erties of the crude drugs to serve as the criteria. The values give n therein are to serve as refere nee values, except those obtained by microscopic observ

58、a- tio n.44. Po wered crude drugs do not contain fragme nts of tissues, cells, cell inclusions or other foreign matters which does not con stitute the origi nal whole or cut crude drugs.45. Powdered crude drugs, unless otherwise specified, may be mixed with diluents so as to attain proper content and