Download 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) 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), 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 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, "Poh Je Bub." In addition, the appendices 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 1).
Table 1: the history of KHP revisions and amendments.
Notification
Contents of revision
MHW Notification No. 84-23 (1984.03.22)
KHP enactment: 152 monographs including Ga Ja
(Terminaliae Fructus)
MHW Notification No. 85-54 (1985.07.19)
KHP 2nd Edition: 276 monographs including Goc Gee
Seng (Visci Herba)
MHW Notification No. 1986-22 (1986.05.01)
KHP annexation (1): 51 monographs including Gam
Song Hyang (Nardostachyos Rhizoma)
MHW Notification No. 1987-86 (1987.12.28)
KHP 3rd Edition: 384 monographs including Ga Ja
(Terminaliae Fructus)
MHW Notification No. 1990-12 (1990.01.25)
the origin of Noc Yong (the young antler of the deer),
revised
MHW Notification No. 1990-42 (1990.05.19)
the origin of Noc Gac (the antler of the deer), revised
MHW Notification No. 1997-72 (1997.09.23)
the quantity of Noc Yong ash contents, revised
MHW Notification No. 1998-19 (1998.02.23)
the quantity of Noc Yong ash contents, revised
MHW Notification No. 1998-33 (1998.05.08)
Noc Yong Joong Poom (Noc Yong mid class, the section
under Noc Yong monograph), promulgated
MHW Notification No. 1998-73 (1998.11.30)
15 new monographs including Gwan Joong
(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 Notification No. 1999-65 (1999.12.20)
the revision of the title of Notification
KFDA Notification No. 2001-2 (2001.01.05)
the standard of Noc Yong, revised
KFDA Notification No. 2001-25 (2001.04.21)
Sa Hyang (a musk), promulgated
KFDA Notification No. 2002-26 (2002.05.29)
41 revisions including Gam Gook (Chrysanthemi Flos),
the promulgation of Chun Pae Mo (Bulbus Fritillariae
Cirrhosae)
KFDA Notification No. 2002-72 (2002.12.21)
8 new monographs including Da Too Ra (Daturae
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 interest, 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 the 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
μg
mole per liter
mol/L
centimeter
cm
nanogram
ng
mass per cent
%
millimeter
mm
picogram
pg
mass parts per million
ppm
micrometer
μm
liter
L
mass parts per billion
ppb
nanometer
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%
hydrogen ion concentration
pH
milligram
mg
2
square centimeter cm
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 in 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 temperature.
12. The following abbreviations are used for the principal units.
KP VIII 8
Units
meter
Abbr.
m
Units
microgram
Abbr.
μg
Units
per
Abbr.
cm-1
centimeter
Units
mass
cm
nanogram
ng
kilopascal
parts
ppm
per million
mass
centimeter
Abbr.
parts
kPa
ppb
per billion
volume
millimeter
mm
picogram
pg
mole per liter
mol/L
vol%
percent
micrometer
μm
liter
L
megahertz
square
Nanometer
nm
milliliter
mL
millimeter
kg
microliter
μL
mm /s
Celsius
gram
g
degree
square
milligram
mg
per million
ppm
volume
w/v%
percent
millipascal
second
vol
mass per
2
per second
kilogram
volume parts
MHz
endotoxin
mPa·s
EU
unit
hydrogen ion
C
newton
cm2
mass percent
N
pH
concentration
%
centimeter
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 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.
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 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
KP VIII 11
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.
KP VIII 12
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.
KP VIII 13
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.