2.General Notices

KP IX 1 General Notices2 General NoticesKP IX 31. This is English version of the Korean Pharmaco-poeia Ninth Edition, which may be abbreviated as KP Ⅸor KP 9.agents, emulsifiers, aromatics, solubilizers, co- loring agents and viscous agents may be added.The excipients used, however, should be non- toxic, harmless and pharmacologically inactive in the amount administered and must not inter- fere with the therapeutic efficacy or the test of the preparations.9. Vegetable oils for the manufacture of any officialpreparation usually indicate the edible vegetable oils listed in the official monographs. When starch is called for the manufacture of any offi- cial 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 ethanol at (or until) the specified vol%.10. Functions which control the releasing rate ofdrug substances, leading to the modified absorp- tion or transfer into the body may be added to pharmaceutical preparations for the purpose of controlling the onset and duration of therapeutic effects and/or decreasing adverse or side effects.However, modified release preparations should meet the corresponding requirements showing preparation characteristics such as dissolution test etc. which specify the releasing rate, unless otherwise specified. In addition, the functional modification of releasing rate should be dis- played on the insert paper and direct container or package of the preparation, unless otherwise specified.11. Immediate-release and modified-release prepara-tions exist in oral dosage forms which show dif- ferent release characteristics, respectively. Im- mediate-release dosage forms are preparations showing a release of drug substances, which is not intentionally modified and generally depen- dent on the intrinsic physicochemical properties of the drug substances. Modified-release dosage forms are preparations showing a release of drug substances, which is suitably modified by a spe- cific formulation design and/or manufacturing method. Modified-release dosage forms include enteric-coated and extended-release preparations.Enteric-coated preparations are designed to re- lease major drug substances in small intestines rather than stomachs in order to prevent the de- gradation or decomposition of drug substances in stomach or to decrease the irritant effect of drug substances on stomachs. Enteric-coated prepara- tions are generally prepared by applying enteric films to preparations. Extended-release prepara- tions are designed to control the releasing rate and time of drug substances and the release sites in gastrointestinal tracts in order to decrease the dosing times and/or to reduce adverse or side ef- fects. Extended-release preparations generally prepared using suitable agents that prolong the drug release. Capsules, tablets, powders, gra- nules and pills of oral dosage forms can be2. Drugs of the Korean Pharmacopoeia are thosespecified in the official monographs exceping Quasi drugs. The official names in the Pharma- copoeia are the title names and the commonly used names adopted in the official monographs.In the official monographs, the titles are accom- panied with chemical names or Latin names as the occasion demands. General requirements for drugs are similarly applied to quasi drugs. In the case of a drug in fine granules which is recog- nized as powder in the General Requirements for Pharmaceutical Preparations, Powder may read Fine Granules.3. Drugs are to be tested according to the provisionsgiven in the pertinent Official Monographs, Gen- eral Notices, General Requirements for Pharma- ceutical Preparations, and the provisions of Gen- eral Tests and Assays for their conformity to the Korean Pharmacopoeia. However, the items of Description excepting color and storage under the Packaging and Storage in the official mono- graphs are given for information, and should not be taken as indicating standard for conformity.But in the case of Crude drugs, color, odor and taste of Description are taken as indicating stan- dard for conformity.4. The names of the drugs listed in the KoreanPharmacopoeia begin with a capital letter in the English version.5. When the contents or the potency in terms of unitsof the active ingredients, or the expiration date is specified in the official monographs of the Ko- rean Pharmacopoeia, these statements should be shown on the immediate container or wrapping.6. The names of drugs or chemicals followed by mo-lecular formulas or constitution formulas in pa- renthesis ( ) designate chemically pure sub- stances. Atomic masses adopted in KP IX con- form to the table of "Standard Atomic Weights 2005". Molecular masses are indicated to two decimal places rounded from the third decimals.7. In stating the amount of content in pharmaceuticalpreparations, the use of an expression "not less than 95.0 % and not more than 105.0 %" , for example, indicates that it is usually prepared so as to contain the labeled amount of the chemical- ly pure substance or one corresponding to it and that it is quantitatively determined in the above range.8. Pharmaceutical excipients are substances con-tained in preparations which are used to increase the utility of the preparation, to enable manufac- turing of drug products easy, to keep product's integrity, to improve the appearance of a formu- lation and so on. For these purposes, suitable ex- cipients such as diluents, stabilizers, preserva- tives, buffering agents, corrigents, suspending4General Notices coated with appropriate coating agents, such as sugar, sugar alcohol or high-molecular mass ma- terials to enable the ingestion easy or to prevent degradation of drug substances.12. Unless otherwise specified, official preparations are preferably stored in the room temperature. point of the solvent, and the term "warmed sol- vent" or "warm solvent" usually means a solvent heated to a temperature between 60 °C and 70 °C. The term "heat on or in a water bath" indicates, unless otherwise specified, heating with a boiling water bath or a steam bath at about 100 °C. Cold extraction and warm extraction are usually per- formed at temperatures of 15 ~ 25 °C and 35 ~ 45 °C, respectively.16. To measure the number of drops, a dropping de- vice which delivers 20 drops of purified water weighing 0.90 to 1.10 g at 20 o C should be used. 17. The name of a solute followed by the word "so- lution" without indication of the name of the sol- vent means aqueous solution.18. The acidity or alkalinity of a solution, unless otherwise specified, is determined by blue or red litmus paper. To indicate these properties more precisely, pH values are used.19. The terms in the following table are used to ex- press the degree of coarseness or fineness of Powder.13. The following principal units.abbreviations are used for the pass through the respective sieve. sonance Spectroscopy(1H) indicates the chemical shift.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 solvent will make the total volume into 10 mL. The liq- uid mixture indicated as (5:2:1) refers the mix- ture of the mixture of 5, 2, and 1 volumes of liq- uids.21. The reagents specified in the General Tests and Assays should be used for the test of drugs, un- less otherwise specified, and the water to be used in the test of drugs should be Purified Water.22. The term "in vacuum" indicates, unless other- wise specified, a pressure not exceeding 2.0 kPa. 23. The term "weigh accurately" means to weigh down to the degree of 0.1 mg, 0.01 mg or 0.001 mg according to the sensitivity in the balance to be used, and the term "weigh exactly" means to weigh to the given decimal places.24. A value of n figures in a test of a drug should be obtained by rounding from a value of (n +1) fig- ures. For example, an expression "not less than 95.0 % and not more than 105.0 %" under assay means that the contents determined by assay is between 94.95 % and 105.04 % to meet the re- quirement.14. The unit used for expressing the potency of drug is recognized as the quantity of drug. Usually, it is expressed by a definite quantity of a definite standard substance which shows a definite bio- logical activity, and differs according to each drug. The units are determined, in principle, by comparison with each reference standard by means of biological methods. The word "unit" used for the articles of this book indicates the unit defined in the Korean Pharmacopoeia.15. The temperature for the tests or the storage is described in specific figures in principle. How- ever, the following expressions may be used in- stead. Standard temperature, ordinary tempera- ture, room temperature and lukewarm are de- fined as 20 °C, 15 ~ 25 °C, 1 ~ 30 °C and 30 ~ 40 °C, respectively. The temperatures of cold water, lukewarm water, warm water and hot wa- ter are defined as not exceeding 10 °C, 30 ~ 40 °C, 60 ~ 70 °C and about 100 °C, respectively. The term "heated solvent" or "hot solvent" means a solvent heated almost to the boilingSieve No. Names of the powders which 4 (4750 μm) Coarse cutting 6.5 (2800 μm) Medium cutting 8.6 (2000 μm) Fine cutting 18 (850 μm) Coarse powder 50 (300 μm) Medium powder 100 (150 μm) Fine powder200 (75 μm)Very fine powderUnits Abbr. Units Abbr. meter m centimeter cm millimeter mm micrometer μm nanometer nm kilogram kg gram g milligram mg microgram μg nanogram ng picogram pg liter L milliliter mL microliter μLCelsius degree°Csquare cen-timetercm 2 per centimeter cm -1 kilopascal kPamole per liter mol/L megahertz MHzsquare millime- ter per secondmm 2/s millipascal second mPa ·snewton N mass percent %mass parts per million ppm mass partsper billionppbvolume percentvol%volume parts per million volppmmass per volume percent w/v% endotoxinunitEUhydrogen ion concentrationpHKP IX 525. Unless otherwise specified, all tests of the drugsshould be performed at ordinary temperature and observations of the results should follow imme- diately after the operations. However, the judg- ment for a test which is affected by temperature should be based on the condition at standard temperature.26. The terms "immediately" or "at once" used in test of a drug mean that the procedure is to be performed within 30 seconds after the preceding procedure.27. In the section under the Description, the term "white" is used to indicate white or practically white, and "colorless" denotes colorless or prac- tically colorless. Unless otherwise specified, the test of color carried out by placing 1 g of the sol- id drug on a sheet of white paper or in a watch glass placed on white paper. Liquid drug is put into a colorless test tube of 15 mm inside diame- ter and is observed in front of a white back- ground through a layer of 30 mm. For test of clarity of a liquid drug, the same procedure is applied with either a black or white background. For the observation of fluorescence of a liquid drug, only a black background should be used. 28. In the section under the Description, the term "odorless" or "no odor" is used to indicate odor- less or practically odorless. Unless otherwise specified, the test of odor should be carried out by placing 1 g of solid drug or 1 mL of the liquid drug in a beaker.29. In the section under the Description, solubilities are expressed in the terms in the following table. Unless otherwise specified, solubility means the degree of dissolution of drug, previously pow- dered in the case of a solid, within 30 minutes in a solvent at 20±5 °C, by vigorous shaking for 30 seconds each time at 5 minute intervals.a clear solution or mixture, and the presence of fibers etc. is not permitted unless in extremely minute quantities.31. Identification is the test necessary to identify the drug or the main ingredients of the drug based upon a specific property.32. Purity is for detecting contaminants in drugs, and it, 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. The contaminants which are con- sidered to be the subject of the test are those sup- posed to contaminate or generate during the course of the manufacturing process or storage, and hazardous contaminants such as heavy met- als, arsenic, etc. If substitution by foreign sub- stances or addition of such materials is expected, the corresponding tests are necessary.33. The term "constant mass" in drying or ignition, unless otherwise specified, means that the mass difference after an additional 1 hour of drying or ignition is not more than 0.10 percent of the pre- ceding mass of the dried substance or ignited re- sidue. In crude drugs, the difference is not more than 0.25 percent. However, when the difference does not exceed 0.5 mg in a chemical balance, 0.05 mg in a semi-microbalance, and 0.005 mg in a microbalance, it is considered that the differ- ence is negligible and constant mass has been at- tained.34. Assay is the test to determine the composition, the content of the ingredients, and the potency unit of drug by physical, chemical or biological procedures.35. The sample quantity for assay indicated with the word "about" means that the weighed quantity of sample may deviate within ±10% of the de- scribed amount. The word "dry" in respect of the sample indicates drying under the same condi- tions, as described in loss on drying in the offi- cial monographs.36. The test methods of the Korean Pharmacopoeia can be replaced by alternative methods which give better accuracy and precision. However, where a difference is suspected, only the result obtained by the procedure given in this Pharma- copoeia is effective for the final judgment.37. The details of the biological test methods may be changed insofar as they do not affect the essen- tial qualities of the test.38. Crude drugs in the official monographs include medicinal parts obtained from plants and animals, cell inclusions and secretes separated from the origins, their extracts, and minerals.39. Crude drugs are usually used in the forms of whole crude drugs, cut crude drugs or powdered crude drugs. Whole crude drugs are the medicin- al parts or their ingredients prepared by drying and/or simple processes, as specified in the offi- cial monographs. Cut crude drugs are small piec-30. In the test of drug, the description "dissolve" or "miscible" indicate that it dissolves in, or mixes with, in arbitrary proportion, the solvent to formDescriptive term Amount of solvent requiredfor dissolving 1 g or 1 mL of solute Very soluble less than 1 mLFreely solublenot less than 1 mL and lessthan 10 mLSolublenot less than 10 mL andless than 30 mLSparingly so- luble not less than 30 mL and less than 100 mLSlightly solublenot less than 100 mL andless than 1000 mLVery slightly so- luble not less than 1000 mL and less than 10000 mL Practically inso- lublenot less than 10000 mL6 General Noticeses or small blocks prepared by cutting or crush- ing 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 fine powder prepared from the whole crude drugs or cut crude drugs, and unless otherwise specified, are required to con- form to the specifications of the whole crude drugs used as original materials.40. Unless otherwise specified, crude drugs are usedin dried form. The drying is usually carried out ata temperature not exceeding 60 o C.41. Crude drugs are as free as possible from conta-minants and other impurities due to molds, in- sects and other animals and from other foreign matters, in the whole process including harvest, processing, packing and distribution, and are re- quired to be kept in a clean and hygienic state. 42. The origin of crude drugs is to serve as the crite-ria for propriety. Such statement as "other spe- cies of the same genus" and "allied plants" or "al- lied animals" in the origin of crude drugs usually indicate plants or animals which may be used as materials for crude drugs containing the same ef- fective constituents.43. The Description in each official monograph ofcrude drugs usually covers the crude drug de- rived from its typical original plant or animal and includes statements of characteristic properties of the crude drugs to serve as the criteria. The val- ues given therein are to serve as reference values, except those obtained by microscopic observa- tion.44. Powered crude drugs do not contain fragments oftissues, cells, cell inclusions or other foreign matters which does not constitute the original whole or cut crude drugs.45. Powdered crude drugs, unless otherwise speci-fied, may be mixed with diluents so as to attain proper content and potency.46. Crude drugs are preserved under protection frommoisture and insect damage, unless otherwise specified. In order to avoid insect damage, suita- ble fumigants may be used to preserve crude drugs. The provided fumigants are so readily vo- latilized as to be harmless at the usual dosage of the crude drugs, and do not affect the therapeutic efficacy of the crude drugs or interfere with the testing.47. Unless otherwise specified, crude drugs are pre-served in well-closed containers.48. The container is the device which holds drugs.The concept of a container also includes consti- tuent parts such as the stopper or cap. The con- tainers have no physical and chemical reactivity affecting the specified description and quality of the contents.49. A well-closed container protects the contentsfrom the invasion of extraneous solids and from loss of the drug under ordinary or customaryconditions of handling and storage. Where a well-closed container is specified, it may be re- placed by a tight container.50. A tight container protects the containers fromcontamination by extraneous liquid or sol- ids, from loss of contents and from efflores- cence, deliquescence, or evaporation under ordi- nary or customary conditions of handling and storage. Where a tight container is specified, it may be replaced by a hermetic container.51. A hermetic container is impervious into any gasand any microbe under ordinary or customary conditions of handling and storage.52. The term "light-resistant" means that it can pre-vent transmittance of light affecting in the speci- fied description and quality of the contents and protect the contained drug from the light under ordinary or customary conditions of handling, transport, and storage. In the case of single do- sage forms, it contains the package which can prevent transmittance of light into an individual direct container.。