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Extracts PDF
Extracts PDF
1. -pinene
3. hexanol
5. linalol
7. -caryophyllene
2. cineole
4. decanal
6. linalyl acetate
8. eugenol
9. benzyl salicylate
Figure 2098.-1. Chromatogram for the test for chromatographic profile of essential oils
Identification of components : use the chromatogram supplied
with essential oil CRS.
System suitability : reference solution :
resolution : minimum 1.5 between the peaks due to linalol
and linalyl acetate ;
signal-to-noise ratio : minimum 100 for the peak due to
decanal ;
limits : the percentage content of each of the 9 components
is within the limits stated on the leaet provided with
essential oil CRS.
STORAGE
In a well-lled, airtight container, protected from light.
LABELLING
The label states :
the scientic name of the plant raw material used ;
where applicable, the type and/or the chemotype of the
essential oil ;
where applicable, the method of production ;
04/2008:0765
EXTRACTS
Extracta
DEFINITION
Extracts are preparations of liquid (liquid extracts and
tinctures), semi-solid (soft extracts and oleoresins) or solid
(dry extracts) consistency, obtained from herbal drugs or
animal matter, which are usually in a dry state.
Where medicinal products are manufactured using extracts of
animal origin, the requirements of chapter 5.1.7. Viral safety
apply.
Different types of extract may be distinguished. Standardised
extracts are adjusted within an acceptable tolerance to a given
content of constituents with known therapeutic activity ;
standardisation is achieved by adjustment of the extract with
inert material or by blending batches of extracts. Quantied
extracts are adjusted to a dened range of constituents ;
adjustments are made by blending batches of extracts. Other
extracts are essentially dened by their production process
(state of the herbal drug or animal matter to be extracted,
solvent, extraction conditions) and their specications.
PRODUCTION
where applicable, the name and concentration of any added
Extracts are prepared by suitable methods using ethanol or
antioxidant ;
other suitable solvents. Different batches of the herbal drug
where applicable, additional processing steps that are not
or animal matter may be blended prior to extraction. The
specied under Denition.
herbal drug or animal matter to be extracted may undergo a
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Extracts
Tinctures tincturae
DEFINITION
Tinctures are liquid preparations that are usually obtained
using either 1 part of herbal drug or animal matter and
10 parts of extraction solvent, or 1 part of herbal drug or
animal matter and 5 parts of extraction solvent.
PRODUCTION
Tinctures are prepared by maceration or percolation (outline
methodology is given below) using only ethanol of a suitable
concentration for extraction of the herbal drug or animal
matter, or by dissolving a soft or dry extract (which has been
produced using the same strength of extraction solvent as
is used in preparing the tincture by direct extraction) of
the herbal drug or animal matter in ethanol of a suitable
concentration. Tinctures are ltered, if necessary.
Tinctures are usually clear. A slight sediment may form on
standing, which is acceptable as long as the composition of
the tincture is not changed signicantly.
Production by maceration. Unless otherwise prescribed,
reduce the herbal drug or animal matter to be extracted to
pieces of suitable size, mix thoroughly with the prescribed
extraction solvent and allow to stand in a closed container
for an appropriate time. The residue is separated from the
extraction solvent and, if necessary, pressed out. In the latter
case, the 2 liquids obtained are combined.
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DEFINITION
Herbal drug preparations are homogeneous products
obtained by subjecting herbal drugs to treatments such as
extraction, distillation, expression, fractionation, purication,
concentration or fermentation.
Herbal drug preparations include, for example, extracts,
Soft extracts extracta spissa
essential oils, expressed juices, processed exudates, and herbal
drugs that have been subjected to size reduction for specic
DEFINITION
applications, for example herbal drugs cut for herbal teas or
Soft extracts are semi-solid preparations obtained by
powdered for encapsulation.
evaporation or partial evaporation of the solvent used for
Herbal teas comply with the monograph Herbal teas (1435).
extraction.
NOTE : the term comminuted used in European Community
TESTS
legislation on herbal medicinal products describes a herbal
Dry residue (2.8.16). The soft extract complies with the limits drug that has been either cut or powdered.
prescribed in the monograph.
The term herbal drug preparation is synonymous with the
term herbal preparation used in European Community
Solvents. Residual solvents are controlled as described in
legislation on herbal medicinal products.
chapter 5.4, unless otherwise prescribed or justied and
authorised.
STORAGE
Protected from light.
Oleoresins oleoresina
DEFINITION
Oleoresins are semi-solid extracts composed of a resin in
solution in an essential and/or fatty oil and are obtained by
evaporation of the solvent(s) used for their production.
This monograph applies to oleoresins produced by extraction
and not to natural oleoresins.
TESTS
Water (2.2.13). The oleoresin complies with the limits
prescribed in the monograph.
Solvents. Residual solvents are controlled as described in
chapter 5.4, unless otherwise prescribed or justied and
authorised.
STORAGE
In an airtight container, protected from light.
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01/2012:1433
HERBAL DRUGS
Plantae medicinales
DEFINITION
Herbal drugs are mainly whole, fragmented, or broken plants,
parts of plants, algae, fungi or lichen, in an unprocessed state,
usually in dried form but sometimes fresh. Certain exudates
that have not been subjected to a specic treatment are also
considered to be herbal drugs. Herbal drugs are precisely
dened by the botanical scientic name according to the
binominal system (genus, species, variety and author).
Whole describes a herbal drug that has not been reduced
in size and is presented, dried or undried, as harvested ; for
example : dog rose, bitter fennel or sweet fennel, Roman
chamomile ower.
Fragmented describes a herbal drug that has been reduced in
size after harvesting to permit ease of handling, drying and/or
packaging ; for example : cinchona bark, rhubarb, passion
ower.
See the information section on general monographs (cover pages)