07 General notices of KP VIII

1 General Notices KP VIII 1 1. This is English version of the Korean Pharmacopoeia Eighth Edition, which may be abbreviated as KP VIII or KP 8. 2. Drugs of the Korean Pharmacopoeia are those specified in the official monographs. The official names in the Pharmacopoeia are the title names and the commonly used names adopted in the official monographs. In the official monographs, the titles are accompanied with chemical names or Latin names as the occasion demands. Quasi drugs are excluded from drugs, but general requirements for drugs are similarly applied to quasi drugs. In the case of a drug in fine granules which is recognized as powder in the General Requirements for Pharmaceutical Preparations, Powder may read Fine Granules. 3. Drugs are to be tested according to the provisions given in the pertinent Official Monographs, General Notices, General Requirements for Pharmaceutical Preparations, and the provisions of General Tests and Assays for their conformity to the Korean Pharmacopoeia. However, absorbance, acidity or alkalinity, boiling point, congealing point, congealing point of fatty acid, crystal form, melting point, odor (excepting crude drugs), refractive index, solubility, specific gravity, specific rotation, stability, taste (excepting crude drugs), and viscosity under Description, and storage under the Containers and Storage of preparations in the official monographs are given for information, and should not be taken as indicating standard for conformity. 4. The names of the drugs listed in the Korean Pharmacopoeia begin with a capital letter in the English version. 5. When the contents or the potency in terms of units of the active ingredients, or the expiration date is specified in the official monographs of the Korean Pharmacopoeia, these statements should be shown on the immediate container or wrapping. 6. The names of drugs or chemicals followed by molecular formulas or constitution formulas in parenthesis ( ) designate chemically pure substances. Atomic masses adopted in KP VIII conform to the table of “Standard Atomic Weights 1999”. Molecular masses are indicated to two decimal places rounded from the third decimals. 7. In stating the amount of content in pharmaceutical preparations, the use of an expression “not less than 95.0% and not more than 105.0%” or “not less than 95.0% and not more than 110.0%”, for example, indicates that it is usually prepared so as to contain the labeled amount of the chemically pure substance or one corresponding to it and that it is quantitatively determined in the above range. 8. In the manufacture of any official preparation, personnel engaged in the processing of medicinal products should be completely familiar with the description, composition and action of the used drugs. There should be a cleaning routine for all equipment and manufacturing areas. Every care should be exercised in the preparation of all products, to prevent contamination risks of all kinds. In particular, use purified water with precautions against bacterial contamination. The details of the procedure of preparation may be altered, provided the finished preparations comply with the specifications prescribed by the Pharmacopoeia. 9. Unless otherwise specified, suitable excipients such as diluents, stabilizers, preservatives, and buffering agents may be added to pharmaceutical preparations to assure the property and quality of the products during storage. These substances, however, must be non-toxic and harmless in the amount administered and should not interfere with the therapeutical efficacy or the tests of the preparations.        10. Vegetable oils for the manufacture of any official preparation usually indicate the edible vegetable oils listed in the Pharmacopoeia. When starch is called for the manufacture of any official preparation, any kind of Starch listed in Pharmacopoeia, 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%. 11. Unless otherwise specified, official preparations are preferably stored in the room temperature. 12. The following abbreviations are used for the principal units. 13. 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 biological 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. 14. Standard temperature, ordinary temperature, room temperature and lukewarm are defined as 20 (C, 15 ~ 25 (C, 1 ~ 30 (C and 30 ~ 40 (C, respectively. A cold place, unless otherwise specified, should be a place having a temperature not exceeding 15 (C. The temperatures of cold water, lukewarm water, warm water and hot water 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 boiling point of the solvent, and the term “warmed solvent” 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 performed at temperatures of 15 ~ 25 (C and 35 ~ 45 (C, respectively. 15. To measure the number of drops, a dropping device which delivers 20 drops of purified water weighing 0.90 to 1.10 g at 20 oC should be used. 16. The name of a solute followed by the word “solution” without indication of the name of the solvent means aqueous solution. 17. 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. 18. The terms in the following table are used to express the degree of coarseness or fineness of Powder. Sieve No. Names of the powders which pass through the respective sieve. 4 (4760 μm) Coarse cutting 7 (2830 μm) Medium cutting 10 (2000 μm) Fine cutting 20 (840 μm) Coarse powder 50 (297 μm) Medium powder 100 (149 μm) Fine powder 200 (74 μm) Very fine powder 19. The concentration of a solution expressed as (1 in 5), (1 in 10) or (1 in 100) mean ratios whereby 1 g of a solid or 1 mL of a liquid chemical dissolved in the solvent will make the total volume into 5 mL. 10 mL or 100 mL, respectively. The liquid mixture indicated as (10:1) or (5:2:1) refers the mixture of 10 and 1 volumes of liquids, or the mixture of 5, 2, and 1 volumes of liquids, respectively. 20. The reagents specified in the General Tests and Assays should be used for the test of drugs, unless otherwise specified, and the water to be used in the test of drugs should be Purified Water. 21. The term “in vacuum” indicates, unless otherwise specified, a pressure not exceeding 2.0 kPa. 22. 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. 23. A value of n figures in a test of a drug should be obtained by rounding from a value of (n+1) figures. 24. Unless otherwise specified, all tests of the drugs should be performed at ordinary temperature and observations of the results should follow immediately after the operations. However, the judgment for a test which is affected by temperature should be based on the condition at standard temperature. 25. 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. 26. In the section under the Description, 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 on white paper. Liquid drug is put into a colorless test tube of 15 mm inside 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 applied with either a black or white background. For the observation of fluorescence of a liquid drug, only a black background should be used. 27. In the section under the Description, the term “odorless” or “no odor” is used to indicate odorless 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 in a beaker. 28. In the section under the Description, solubilities are expressed in the terms in the following table. Unless otherwise directed, solubility means the degree of dissolution of drug, previously powdered 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. Descriptive term Solvent required for 1 g or 1 mL of solute Very soluble less than 1 mL Freely soluble not less than 1 mL and less than 10 mL Soluble not less than 10 mL and less than 30 mL Sparingly soluble not less than 30 mL and less than 100 mL Slightly soluble not less than 100 mL and less than 1000 mL Very slightly soluble not less than 1000 mL and less than 10000 mL Practically insoluble not less than 10000 mL 29. In the test of drug, the description “dissolve” or “miscible” indicate that it dissolves in, or mixes with, in arbitrary proportion, the solvent to form a clear solution or mixture, and the presence of fibers etc. is not permitted unless in extremely minute quantities. 30. Identification is the test necessary to identify the drug or the main ingredient of the drug based upon a specific property. 31. 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 considered to be the subject of the test are those supposed to contaminate the drug during the course of the manufacturing process or storage, and hazardous contaminants such as heavy metals, arsenic, etc. If substitution by foreign substances or addition of such materials is expected, the corresponding tests are necessary. 32. The term “constant weight” in drying or ignition, unless otherwise specified, means that the weight difference after an additional 1 hour of drying or ignition is not more than 0.10 percent of the preceding weight of the dried substance or ignited residue. 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 difference is negligible and constant weight has been attained. 33. 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. 34. The sample quantity for assay indicated with the word “about” means that the weighed quantity of sample may deviate within ±10% of the described amount. The word “dry” in respect of the sample indicates drying under the same conditions, as described in loss on drying in the official monographs. 35. In the official monographs, if the content of an ingredient determined by Assay is expressed simply as not less than a certain percentage without indicating its upper limit, 101.0% is understood as the upper limit. 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 Pharmacopoeia is effective for the final judgment. 37. The details of the biological test methods may be changed insofar as they do not affect the essential 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 medicinal parts or their ingredients prepared by drying and/or simple processes, as specified in the official monographs. Cut crude drugs are small pieces or small blocks prepared by cutting or crushing of the whole crude drugs, and also coarse, medium or fine cutting of the crude drugs in whole, and unless otherwise specified, are required to conform to the specifications of the whole crude drugs used as original materials. Powdered crude drugs are coarse, medium, fine or very fine powder prepared from the whole crude drugs or cut crude drugs. Usually, powdered crude drugs as fine powder are specified in the official monographs. 40. Unless otherwise specified, crude drugs are used in dried form. The drying is usually carried out at a temperature not exceeding 60 oC. 41. Crude drugs are as free as possible from contaminants and other impurities due to molds, insects and other animals and from other foreign matters, and are required to be kept in a clean and hygienic state. 42. Such statement as “other species of the same genus” and “allied plants” or “allied animals” appearing in the origin of crude drugs usually indicate plants or animals which may be used as materials for crude drugs containing the same effective constituents. 43. The Description in each official monograph of crude drugs usually covers the crude drug derived from its typical original plant or animal and includes statements of characteristic properties of the crude drugs to serve as the criteria. The values given therein are to serve as reference values, except those obtained by microscopic observation. 44. Powered crude drugs do not contain fragments of tissues, cells, cell inclusions or other foreign matters which does not constitute the original whole or cut crude drugs. 45. Powdered crude drugs, unless otherwise specified, may be mixed with diluents so as to attain proper content and potency. 46. Crude drugs are preserved under protection from moisture and insect damage, unless otherwise specified. In order to avoid insect damage, suitable fumigants may be used to preserve crude drugs, provided that the fumigants are so readily volatilized as to be harmless at the usual dosage of the crude drugs, and such fumigants do not affect the therapeutic efficacy of the crude drugs or interfere with the testing. 47. Unless otherwise specified, crude drugs are preserved in well-closed containers. 48. The container is the device which holds drugs. The concept of a container also includes constituent parts such as the stopper or cap. 49. A well-closed container protects the contents from the invasion of extraneous solids and loss of the drug under ordinary or customary conditions of handling and storage. Where a well-closed container is specified, it may be replaced by a tight container. 50. A tight container protects the containers from contamination by extraneous liquids, solids or moisture, from loss of contents, and from efflorescence, deliquescence, or evaporation under ordinary 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 to any gas and any microbe under ordinary or customary conditions of handling and storage. 52. The term “light-resistant” means that it can prevent transmittance of light affecting in the specified description and quality of the contents and protect the contained drug from the light under ordinary or customary conditions of handling, transport, and storage. 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