The Korean Herbal Pharmacopoeia

KP VIII 1

THE KOREAN HERBAL PHARMACOPOEIA HISTORY

THE KOREAN HERBAL PHARMACOPOEIA (KHP) was published the part 1 and 2 in 1984; the second edition of KHP in 1985 and its 1986 annexation (1) followed. The third edition of KHP (KHP 3) 3) with total of 384 official monographs was promulgated in 1987. According to the government reformation with the inauguration of the Korea Food and Drug Administration (KFDA), (KFDA), the superintendence of the enactment and the revision of KHP was transferred from the Ministry of Health and Welfare (MHW) to KFDA as of KFDA Notification No. 1995-65 (1999.12.20). This edition of KHP includes the contents of such from KHP 3 to KFDA Notification Notification No. 2002-72 (2002.12.21) and the removed contents by the eighth revision of the Korean Pharmacopoeia (KP 8; KFDA Notification No. 2002-73, 2002.12.30) with total of 383 official monographs. The references are the General Notices of KP 8 and the revised pre-processing methods, methods, "Poh Je Bub." In addition, the appendices with with the nomenclatures in Latin, Scientific and Common, and Korean are for easy indexation. The following table lists the history of KHP after the first edition in 1984 (Table (Table 1). Table 1: the history of KHP revisions and amendments. Notification

Contents of revision

MHW Notification No No. 84 84-23 (1 (1984.03.22)

KHP enactment: 15 152 mo monographs in including Ga Ga Ja Ja (Terminaliae Fructus)

MHW Notif tification No. 85-54 (1985.07.19)

KHP 2nd Edition ion: 276 monographs inc including Goc Gee Seng (Visci Herba)

MHW Notif tificat icatio ion n No. 1986 1986--22 (1986 1986.0 .05 5.01) .01)

KHP annex nnexaation tion (1): 1): 51 monog onogrraphs phs inc includi luding ng Gam Song Hyang (Nardostachyos Rhizoma)


KHP 3rd 3rd Editi dition on:: 384 384 monog onogrraphs phs inc includi luding ng Ga Ja (Terminaliae Fructus)

MHW Notif tificat icatio ion n No. No. 1990 1990--12 (1990 1990.0 .01 1.25) .25)

the the or origin igin of Noc Yong ong (th (thee you young ng antle ntlerr of of the the deer deer)), revised


the the or origin igin of Noc Gac (the the ant antle lerr of of the the deer deer)), re revise vised d


the the qua quantit ntity y of Noc Yong ong ash conte ontent ntss, revise vised d


the the qua quantit ntity y of Noc Yong ong ash conte ontent ntss, revise vised d


Noc Yong ong Joo Joong ng Poom oom (N (Noc Yong mid cla class, ss, the the sec section tion under Noc Yong monograph), promulgated

MHW Notif tification No No. 19 1998-73 (1 (1998.11.30)

15 ne new monographs including Gw Gwan Jo Joong (Crassirhizomae (Crassirhizomae Rhizoma), the removal of Goc Gee, 57 revisions including Gal Hwa (Puerariae Flos), the revision on Noc Yong Joong Poom to Noc Yong Gac

KFDA FDA Notif otific icaation tion No. 1999999-65 65 (1999 1999..12.2 12.20) 0)

the the revi revisi sion on of the the titl titlee of Notif otific icaatio tion

KFDA Notification No No. 20 2001-2 (2 (2001.01.05)

the st standard of of No Noc Yong, re revised

KFDA Notifi ificatio tion No. 2001-25 (2001.04.21)

Sa Hyang (a musk), promulgated


41 revis evisio ion ns inc inclu ludi ding ng Gam Go Gook (Chr Chrysant santhe hem mi Flo Flos) s),, the promulgation of Chun Pae Mo (Bulbus Fritillariae Cirrhosae)


8 ne new monog onogrraphs phs incl includ udin ing g Da Da Too Ra Ra (Datu Daturrae

KP VIII 2

Folium), 17 removals including Gwa Roo In (Trichosanthis Semen), 255 revisions including Ga Ja (Terminaliae Fructus)

KP VIII 3

Foreword

The Korean Herbal Pharmacopoeia (KHP), first published in 1984 as a Notification of the Ministry of Health & Welfare, contained 387 monographs of herbal medicines which were not included in the Korean Pharmacopoeia (KP) Part II. Although the current edition of the KHP is the result of the fifteenth revision of the original form and the English version of the KP has been published in 1998, the English translation of the KHP has not been realized. On that note, I feel that the first English version of the KHP is particularly meaningful. Since the publication of the first edition of the KHP, a significant interest has been drawn for the oriental herbal medicine as a potential alternative for the western medicine. Despite the i nterest, however, information contained in the KHP has not been readily communicated abroad because of the lack of a reliable English version. With this English version, we wish that the publication would be a good opportunity to introduce the Korean herbal medicines to western world and promote international harmonization in the quality control and use of herbal medicines. Chang-Koo Shim Commissioner Korea Food and Drug Administration

KP VIII 4

Summary of the Revision The amendments from the Korean Herbal Pharmacopoeia Third Edition (KHP 3) are as followed: 1. The revised and notified contents after Korean Herbal Pharmacopoeia Third Edition are shown in this edition. 2. The order of the contents is the General Principles , the General Notices of the Korean Pharmacopoeia Eighth Edition, the official monographs of each drug, Poh Je Bub, the general assay methods, and the indices. 3. The monographs are indexed alphabetically. 4. Each monograph is recorded in the following order, excluding the void data: 1) name in Latin

7) identification

13) oil content

2) name in Korean

8) purity test

14) extract content

3) definition

9) loss on drying

15) quantitative assay

4) content rule

10) moisture content

16) storage

5) manufacturing

11) ash

17) processing (Poh Je Bub)

6) description

12) acid insoluble ash

18) grade

5. The identification is conducted in the following order, excluding the void data: 1) color reaction

5) special reaction

2) precipitation reaction

6) qualitative assay of positive and negative ions

3) decomposition reaction

7) filter paper chromatography, thin layer chromatography

4) ultraviolet spectrum, visible spectrum, infrared absorption spectrum

8) gas chromatography, liquid chromatography

6. The purity test is conducted in the following order, excluding the void data: 1) color, odour, taste and etc.

4) arsenic

7) evaporation residue

2) inorganic salt

5) organic

8) color product with sulfuric acid

3) heavy metal

6) foreign substance

7. Extract contents are listed in the following order, excluding the void data: 1) weak ethanol extract

3) ether extract

2) water extract

4) etc.

8. The followings are revisions, addenda, or eliminations at the General Provisions: 1) The full title in English is added as the Korean Herbal Pharmacopoeia (the article 1). 2) The clause, "However, the grade, the processing method, and the storage conditions on the official monograph are given for information, and should not be taken as indicating standard for conformity." is added (the article 4).

3) The measuring units and the term have been revised as "l , ml , l , °, weight" to "L, mL, L, °C, mass or quantity of matter," respectively, and are added to the Korean Pharmacopoeia Eighth Edition, the article 12 (the article 5). 4) The article related to extreme quantity is eliminated.

KP VIII 5

9. The revised details on the official monographs are as followed: 1) The Korean Herbal Pharmacopoeia records total of 383 official monographs: 21 new monographs and 21 eliminations from KHP 3 that has total of 384 official monographs. 2) The additional monographs are as followed (20 monographs): ALOE, AUCKLANDIAE RADIX, AURANTII PERICARPIUM, BULBUS FRITILLARIAE CIRRHOSAE, CANTHARIDES, CATALPAE FRUCTUS, CINCHONAE CORTEX, CRASSIRHIZOMAE RHIZOMA, DATURAE FOLIUM, DIGENEA, DIPSACI RADIX, ERGOTA PREPARATA, FEL URSI, GINSENG RADIX PALVA, GRANATI CORTEX, MOSCHUS, RAUWOLFIA RADIX, RHEI UNDULATAI RHIZOMA, SCOPOLIAE FOLIUM, STROPHANTHI SEMEN 3) The eliminated monographs are as followed (21 monographs): AMOMI ROTUNDUS FRUCTUS, ANGELICAE KOREANAE RADIX, ANGELICAE PUBESCENTIS RADIX, ARISAEMATIS RHIZOMA, ASPARAGI RADIX, DEPOSITUM URINAE PRAEPARATUM, EPIMEDII HERBA, FRITILLARIAE BULBUS, GASTRODIAE RHIZOMA, GINKGONIS FOLIUM, LONGAN ARILLUS, LONICERAE FLOS, NELUMBINIS SEMEN, PAEONIAE RADIX RUBRA, POGSTEMI HERBA, POLYGONATI RHIZOMA, REHMANNIAE RADIX, SALVIAE MILTIORRHIZAE RADIX, SCROPHULARIAE RADIX, TRICHOSANTHIS SEMEN, VISCI HERBA

General Notices of the Korean Herbal Pharmacopoeia Fourth Edition 1. This is the Korean Herbal Pharmacopoeia Fourth Edition that may be abbreviated to KHP 4 or to KHP IV. 2. The drugs of the Korean Herbal Pharmacopoeia are those specified in the official monographs. The official names in the Pharmacopoeia are the title names and the commonly used names such as Latin names adopted in the official monographs. 3. Unless otherwise specified in the Korean Herbal Pharmacopoeia, the General Notices , the General Requirements for Pharmaceutical Preparations, and the provisions of t he General Tests and Assays for their conformity to the Korean Pharmacopoeia are applied. 4. The property of drugs is the subject of judgment, according to the rules and the provisions in the official monographs and the General Provisions. However, the grade, the processing method, and the storage conditions on the official monograph are given for information, and should not be taken as indicating standard for conformity. 5. The following units are used with abbreviations such as followings: meter

m

microgram

centimeter

cm

nanogram

millimeter

mm

picogram

micrometer

μm

nanometer

μg

mole per liter

mol/L

mass per cent

%

pg

mass parts per million

ppm

liter

L

mass parts per billion

ppb

nm

milliliter

mL

volume per cent

vol%

kilogram

kg

microliter

μL

volume parts per million

vol ppm

gram

g

Celsius degree

°C

mass per volume per cent

w/v%

milligram

mg

square centimeter

cm2

hydrogen ion concentration

pH

ng

KP VIII 6

6. Each monograph is recorded in the order and by the method, according to those of the Korean Pharmacopoeia Eighth Edition. In addition, the KHP 4 includes the categories of Grade and Processing. 7. Crude drugs in the official monographs include medicinal parts obtained from plants and animals, cell inclusions, secretes separated from the origins, the extracts, and minerals. 8. 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. 9. Unless otherwise specified, crude drugs are used in dried form. The drying is usually carried out at a temperature not exceeding 60 °C. 10. Crude drugs are as free as possible from contaminants and other impurities due to moulds, insects and other animals and from other foreign matters, and are required to be kept i n a clean and hygienic state. 11. Such statement as "other species of the same genus," "allied plants," or "allied animals" appearing in the definition usually indicates plants or animals that may be used as materials containing the same effective constituents. 12. The description in each official monograph of crude drugs usually covers the crude drug derived from its typical original plant or animal, including 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. 13. Powered crude drugs do not contain fragments of tissues, cells, cell inclusions or other foreign matters which do not constitute the original whole or cut crude drugs. 14. Powdered crude drugs, unless otherwise specified, may be mixed with diluents so as to attain the proper content and potency. 15. Crude drugs should be 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. Such fumigants are so readily volatilized 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 testing. 16. Unless otherwise specified, crude drugs preserved in well-closed containers. 17. The Grade of crude drugs defines the range of the good conditions of crude drugs, among the adequate ones in the pertinent to the rules of the official monographs. 18. The Processing category of crude drugs lists the generally representative title of the processing method(s) of the crude drug.

KP VIII 7

General Notices 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 t emperature. 12. The following abbreviations are used for the principal units.

KP VIII 8

Units

Abbr.

Units

Abbr.

Units

Abbr. -1

Units

Abbr.

meter

m

microgram

μg

per centimeter

cm

mass parts ppm per million

centimeter

cm

nanogram

ng

kilopascal

kPa

mass parts ppb per billion

millimeter

mm

picogram

pg

mole per liter

mol/L

volume percent

micrometer

μm

liter

L

megahertz

MHz

volume parts vol per million ppm

Nanometer

nm

milliliter

mL

square millimeter per second

mm2/s

mass per volume percent

w/v%

kilogram

kg

microliter

μL

millipascal second

mPa·s

endotoxin unit

EU

gram

g

Celsius degree

°

newton

N

hydrogen ion pH concentration

milligram

mg

square centimeter

cm2

mass percent

%

C

vol%

Note : “ppm” used in the Nuclear Magnetic Resonance Spectroscopy(1H) indicates the chemical shift.

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 °

°

KP VIII 9

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 t o 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.

KP VIII 10

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 t he 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


Sparingly soluble


KP VIII 11

Slightly soluble


Very slightly soluble


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.

KP VIII 12

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 i n 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

KP VIII 13

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.

The Korean Herbal Pharmacopoeia

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