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Comparison Of
Herbal Monograph In
Pharmacopeia
Presenting:- Priya Jadhav M201013
Subject Incharge:- Dr. Alka Mukne Mam
2
Topic Name: Comparison Of Herbal
Monograph In Pharmacopeia
OPIUM
4
OPIUM INDIAN
PHARMACOPEIA
BRITISH
PHARMACOPEIA
Synonyms Papaver, Aphu Not Given
Biological
Source
Air-dried latex obtained by
incision from the unripe
capsules of Papaver
somniferum L.
Opium is the air-dried latex
obtained by incision from
the unripe capsules of
Papaver somniferum Linn
Description Explained with the diagram
Masses of various sizes which
tend to be soft and shiny and,
after drying, hard and brittle;
usually in somewhat
irregularly shaped masses
(natural opium) or moulded
into masses of more uniform
size and shape
(manipulated opium); color,
blackish brown; odour:-strong
and characteristic.
appearance and common
description is given
5
INDIAN
PHARMACOPEIA
BRITISH
PHARMACOPEIA
Preparation
example
Preparation example is
not given under main
heading
Preparation example is
given under main
heading
e.g. Opium Tincher
Definition Title No title for synonyms
and biological source
Synonyms and biological
source is given under the
definition title
System suitability
Reference Solution
for thebaine
No Limitation is given number of theoretical
plates:- minimum 3000;
mass distribution ratio:-
minimum 3.0 for the
peak due to thebaine.
6
INDIAN
PHARMACOPEIA
BRITISH
PHARMACOPEIA
Identification
Test
(First step and solutions
heading is given in italic)
TLC silica gel G plate
Mobile phase:- freshly
prepared mixture of
acetone, toluene, ethanol
(95 per cent), strong
ammonia solution
(20:20:3:1 V/V/V/V)
Stationary Phase:
octylsilane bonded to
porous silica (5 μm)
(Heading of all steps in
identification is given in
italic)
TLC silica gel G plate
Mobile phase:- freshly
prepared mixture of
concentrated ammonia R,
ethanol (96 per cent) R,
acetone R, toluene R
(2:6:40:40 V/V/V/V)
Stationary Phase
octylsilyl silica gel for
chromatography (5 μm)
7
Test solution. Triturate 0.1 g of the powdered substance
with 5 ml of ethanol (70 per cent)
add 3 ml of ethanol (70 per cent)
transfer to a 25-ml conical flask and heat in a water-bath
at 50º to 60º for 30 minutes, with stirring
Cool, filter, wash the
filter with ethanol (70 per cent)
and dilute the filtrate to 10 ml
with the same solvent.
This is same in both Pharmacopeia
8
INDIAN PHRAMACOPEIA BRITISH PHARMACOPEIA
Calculation
Formulas
W1×A2×625×100
W2×A1×5(100-h)
w1 = weight in g, of the alkaloid
used to prepare the reference
solution,
w2 = weight, in g, of the
substance under examination
used to prepare the test solution,
A1 = area of the peak
corresponding to the alkaloid in
the chromatogram obtained with
the reference solution,
A2 = area of the peak
corresponding to the alkaloid in
the chromatogram obtained with
the test solution,
h = percentage loss on drying.
M1×A2×625 100
×
M2×A1×5 100-h
M1=mass of the alkaloid used to
prepare the reference solution
M2=mass of the substance to be
examined used to prepare the test
solution
A1=area of the peak due to the
alkaloid in the chromatogram
obtained with the reference
solution
A2=area of the peak due to the
alkaloid in the chromatogram
obtained with the test
solution
h=percentage loss on drying.
9
INDIAN
PHARMACOPEIA
BRITISH PHARMACOPEIA
Loss on drying
Total ash value
Maximum 15.0 per cent,
determined on 0.25 g cut
into thin slices, by drying in
an oven at 105º for 4 hours.
Maximum 6.0 per cent,
determined on 0.5 g.
Maximum 15.0 per cent,
determined on 1.000 g of the
substance to be examined cut
into thin slices, by drying in an
oven at 105 °C for 4 h.
Maximum 6.0 per cent.
Thebaine Not more than 3 per cent,
calculated on the dried
basis.
Same as mentioned
Microbial
contamination
1.0 g is free from Escherichia
coli and 10 g is free from
salmonellae.
Not mentioned
10
INDIAN
PHARMACOPEIA
BRITISH
PHARMACOPEIA
Monograph
Example
Opium Dry Powder
preparation is
given
Opium Tincher
monograph is given
Storage
Label
Store protected
from light and
moisture
The label states
the name of any
added substance
No storage
condition is given
No labelling
instruction
SENNA
12
SENNA INDIAN
PHARMACOPEIA
BRITISH
PHARMACOPEIA
Synonyms Cassia leaf Alexandrian, Khartoum,
Tinnevelly senna
Biological
Source
Senna leaf consists of
the dried compound
leaves of Cassia
angustifolia or Cassia
senna Vhal.
Dried leaflets of Cassia
senna L. (C. acutifolia
Delile),
Family
STORAGE
Family: Leguminosae
Protected from
moisture and light
Family is not
mentioned
Protected from
moisture
13
SENNA BRITISH
PHARMACOPEIA
INDIAN
PHARMACOPEIA
Main heading
details
Preparation example is given
after main heading
Preparation example is not
given after the heading
Information
about the
standard
preparation test
Standardized Senna Leaf Dry
Extract When Powdered Senna
Leaf is prescribed or demanded,
material complying with the
requirements below with the
exception of Identification test A
and the test for Foreign matter
shall be dispensed or supplied.
No such specification is given
Definition Title Synonyms and biological source is
given under the definition title
No title for synonyms and
biological source
14
SENNA BRITISH PHARMACOPEIA INDIAN PHARMACOPEIA
Identification
test 0.5 g of the powdered drug
add 5 ml of a mixture of equal
volumes of ethanol (96 per cent)
and water
heat to boiling Centrifuge
Use the supernatant liquid for
the test
Take 1 g of the dried leaves
powder substance under
examination.
Add 25 ml of methanol, reflux
for 10 minutes, cool and filter.
Reflux the residue with another
20 ml of methanol, cool and
filter.
Combine all the filtrates and
concentrate to 10 ml.
“
◎ ASSAY OF BRITISH
PHARMACOPEIA
15
16
Carry out the assay protected from bright light. Place 0.150 g of the
powdered drug in 100 ml flask.
Add 30.0 ml of water, mix, weigh and place in a water-bath.
Heat under a reflux condenser for 15 min. Allow to cool, weigh and adjust
to the original mass with water.
Centrifuge and transfer 20.0 ml of the supernatant liquid to a 150 ml
separating funnel. Add 0.1 ml of dilute hydrochloric acid and shake with 3
quantities, each of 15 ml of chloroform.
17
Allow to separate and discard the chloroform layer. Add 0.10 g of sodium
hydrogen carbonate and shake for 3 min.
Centrifuge and transfer 10.0 ml of the supernatant liquid to a 100 ml
round-bottomed flask with a ground-glass neck.
Add 20 ml of ferric chloride solution and mix. Heat for 20 min in a water-
bath under a reflux condenser with the water level above that of the
liquid in the flask;
add 1 ml of hydrochloric acid and heat for a further 20 min, with frequent
shaking, to dissolve the precipitate. Cool, transfer the mixture to a
separating funnel and shake with 3 quantities
18
Each of 25 ml, of ether previously used to rinse the flask.
Combine the 3 ether layers and wash with 2 quantities, each of 15 ml, of water
Transfer the ether layer to a volumetric flask and dilute to 100.0 ml with ether
Evaporate 10.0 ml carefully to dryness and dissolve the residue in 10.0 ml of a 5g/l
solution of magnesium acetate in methanol
Measure the absorbance at 515nm, using methanol as the compensation liquid.
19
ASSAY OF INDIAN PHARAMCOPEIA
Weigh accurately 1.0 g of the coarsely powdered
substance in a round bottom flask
add about 10 ml of 1 per cent v/v acetic acid and 25 ml of methanol and reflux
on a water bath for about 30 minutes.
Cool to room temperature; make up the volume up to 50.0 ml with methanol and
filter.
20
BRITISH
PHARMACOPEIA
INDIAN PHARMACOPEIA
Chromatographic
system limitation
There are no
chromatographic system
limitation are given
➢ a stainless steel column 25 cm x 4.6
mm packed with octadecylsilane
bonded to porous silica (5 μm)
➢ mobile phase: a mixtures of 82
volumes of 1 per cent v/v acetic acid
in water and 18 volumes of
acetonitrile
➢ flow rate. 1 ml per minute
➢ spectrophotometer set at 350 nm
➢ a 20 μl loop injector.
Calculation
formula
i.e. taking the specific
absorbance of sennoside B to
be 240.
A×1.25
m
A= absorbance at 515 nm,
m= mass of the substance to
be examined, in grams.
Formula is not mentioned.
21
BRITISH
PHARMACOPEIA
INDIAN
PHARMACOPEIA
Foreign matter Maximum 3 per cent of
foreign organs and
maximum 1 per cent of
foreign elements.
Not more than 1.0 per cent
Loss on drying Maximum 12.0 per cent,
determined on 1.000 g of
the powdered drug by
drying in an oven at 105
°C for 2 h.
Not more than 12.0 per cent,
determined on 5 g of powder
drug by drying in an oven at
105°.
Total ash Maximum 12.0 per cent. Not more than 14.0 per cent
Ash insoluble in
hydrochloric
acid
Maximum 2.5 per cent. Not more than 2.5 per cent.
Microbial
contamination.
Not given Complies with the microbial
contamination tests.
THANK YOU…..
22

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Monograph Comparison By Priya.pdf

  • 2. Presenting:- Priya Jadhav M201013 Subject Incharge:- Dr. Alka Mukne Mam 2 Topic Name: Comparison Of Herbal Monograph In Pharmacopeia
  • 4. 4 OPIUM INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Synonyms Papaver, Aphu Not Given Biological Source Air-dried latex obtained by incision from the unripe capsules of Papaver somniferum L. Opium is the air-dried latex obtained by incision from the unripe capsules of Papaver somniferum Linn Description Explained with the diagram Masses of various sizes which tend to be soft and shiny and, after drying, hard and brittle; usually in somewhat irregularly shaped masses (natural opium) or moulded into masses of more uniform size and shape (manipulated opium); color, blackish brown; odour:-strong and characteristic. appearance and common description is given
  • 5. 5 INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Preparation example Preparation example is not given under main heading Preparation example is given under main heading e.g. Opium Tincher Definition Title No title for synonyms and biological source Synonyms and biological source is given under the definition title System suitability Reference Solution for thebaine No Limitation is given number of theoretical plates:- minimum 3000; mass distribution ratio:- minimum 3.0 for the peak due to thebaine.
  • 6. 6 INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Identification Test (First step and solutions heading is given in italic) TLC silica gel G plate Mobile phase:- freshly prepared mixture of acetone, toluene, ethanol (95 per cent), strong ammonia solution (20:20:3:1 V/V/V/V) Stationary Phase: octylsilane bonded to porous silica (5 μm) (Heading of all steps in identification is given in italic) TLC silica gel G plate Mobile phase:- freshly prepared mixture of concentrated ammonia R, ethanol (96 per cent) R, acetone R, toluene R (2:6:40:40 V/V/V/V) Stationary Phase octylsilyl silica gel for chromatography (5 μm)
  • 7. 7 Test solution. Triturate 0.1 g of the powdered substance with 5 ml of ethanol (70 per cent) add 3 ml of ethanol (70 per cent) transfer to a 25-ml conical flask and heat in a water-bath at 50º to 60º for 30 minutes, with stirring Cool, filter, wash the filter with ethanol (70 per cent) and dilute the filtrate to 10 ml with the same solvent. This is same in both Pharmacopeia
  • 8. 8 INDIAN PHRAMACOPEIA BRITISH PHARMACOPEIA Calculation Formulas W1×A2×625×100 W2×A1×5(100-h) w1 = weight in g, of the alkaloid used to prepare the reference solution, w2 = weight, in g, of the substance under examination used to prepare the test solution, A1 = area of the peak corresponding to the alkaloid in the chromatogram obtained with the reference solution, A2 = area of the peak corresponding to the alkaloid in the chromatogram obtained with the test solution, h = percentage loss on drying. M1×A2×625 100 × M2×A1×5 100-h M1=mass of the alkaloid used to prepare the reference solution M2=mass of the substance to be examined used to prepare the test solution A1=area of the peak due to the alkaloid in the chromatogram obtained with the reference solution A2=area of the peak due to the alkaloid in the chromatogram obtained with the test solution h=percentage loss on drying.
  • 9. 9 INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Loss on drying Total ash value Maximum 15.0 per cent, determined on 0.25 g cut into thin slices, by drying in an oven at 105º for 4 hours. Maximum 6.0 per cent, determined on 0.5 g. Maximum 15.0 per cent, determined on 1.000 g of the substance to be examined cut into thin slices, by drying in an oven at 105 °C for 4 h. Maximum 6.0 per cent. Thebaine Not more than 3 per cent, calculated on the dried basis. Same as mentioned Microbial contamination 1.0 g is free from Escherichia coli and 10 g is free from salmonellae. Not mentioned
  • 10. 10 INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Monograph Example Opium Dry Powder preparation is given Opium Tincher monograph is given Storage Label Store protected from light and moisture The label states the name of any added substance No storage condition is given No labelling instruction
  • 11. SENNA
  • 12. 12 SENNA INDIAN PHARMACOPEIA BRITISH PHARMACOPEIA Synonyms Cassia leaf Alexandrian, Khartoum, Tinnevelly senna Biological Source Senna leaf consists of the dried compound leaves of Cassia angustifolia or Cassia senna Vhal. Dried leaflets of Cassia senna L. (C. acutifolia Delile), Family STORAGE Family: Leguminosae Protected from moisture and light Family is not mentioned Protected from moisture
  • 13. 13 SENNA BRITISH PHARMACOPEIA INDIAN PHARMACOPEIA Main heading details Preparation example is given after main heading Preparation example is not given after the heading Information about the standard preparation test Standardized Senna Leaf Dry Extract When Powdered Senna Leaf is prescribed or demanded, material complying with the requirements below with the exception of Identification test A and the test for Foreign matter shall be dispensed or supplied. No such specification is given Definition Title Synonyms and biological source is given under the definition title No title for synonyms and biological source
  • 14. 14 SENNA BRITISH PHARMACOPEIA INDIAN PHARMACOPEIA Identification test 0.5 g of the powdered drug add 5 ml of a mixture of equal volumes of ethanol (96 per cent) and water heat to boiling Centrifuge Use the supernatant liquid for the test Take 1 g of the dried leaves powder substance under examination. Add 25 ml of methanol, reflux for 10 minutes, cool and filter. Reflux the residue with another 20 ml of methanol, cool and filter. Combine all the filtrates and concentrate to 10 ml.
  • 15. “ ◎ ASSAY OF BRITISH PHARMACOPEIA 15
  • 16. 16 Carry out the assay protected from bright light. Place 0.150 g of the powdered drug in 100 ml flask. Add 30.0 ml of water, mix, weigh and place in a water-bath. Heat under a reflux condenser for 15 min. Allow to cool, weigh and adjust to the original mass with water. Centrifuge and transfer 20.0 ml of the supernatant liquid to a 150 ml separating funnel. Add 0.1 ml of dilute hydrochloric acid and shake with 3 quantities, each of 15 ml of chloroform.
  • 17. 17 Allow to separate and discard the chloroform layer. Add 0.10 g of sodium hydrogen carbonate and shake for 3 min. Centrifuge and transfer 10.0 ml of the supernatant liquid to a 100 ml round-bottomed flask with a ground-glass neck. Add 20 ml of ferric chloride solution and mix. Heat for 20 min in a water- bath under a reflux condenser with the water level above that of the liquid in the flask; add 1 ml of hydrochloric acid and heat for a further 20 min, with frequent shaking, to dissolve the precipitate. Cool, transfer the mixture to a separating funnel and shake with 3 quantities
  • 18. 18 Each of 25 ml, of ether previously used to rinse the flask. Combine the 3 ether layers and wash with 2 quantities, each of 15 ml, of water Transfer the ether layer to a volumetric flask and dilute to 100.0 ml with ether Evaporate 10.0 ml carefully to dryness and dissolve the residue in 10.0 ml of a 5g/l solution of magnesium acetate in methanol Measure the absorbance at 515nm, using methanol as the compensation liquid.
  • 19. 19 ASSAY OF INDIAN PHARAMCOPEIA Weigh accurately 1.0 g of the coarsely powdered substance in a round bottom flask add about 10 ml of 1 per cent v/v acetic acid and 25 ml of methanol and reflux on a water bath for about 30 minutes. Cool to room temperature; make up the volume up to 50.0 ml with methanol and filter.
  • 20. 20 BRITISH PHARMACOPEIA INDIAN PHARMACOPEIA Chromatographic system limitation There are no chromatographic system limitation are given ➢ a stainless steel column 25 cm x 4.6 mm packed with octadecylsilane bonded to porous silica (5 μm) ➢ mobile phase: a mixtures of 82 volumes of 1 per cent v/v acetic acid in water and 18 volumes of acetonitrile ➢ flow rate. 1 ml per minute ➢ spectrophotometer set at 350 nm ➢ a 20 μl loop injector. Calculation formula i.e. taking the specific absorbance of sennoside B to be 240. A×1.25 m A= absorbance at 515 nm, m= mass of the substance to be examined, in grams. Formula is not mentioned.
  • 21. 21 BRITISH PHARMACOPEIA INDIAN PHARMACOPEIA Foreign matter Maximum 3 per cent of foreign organs and maximum 1 per cent of foreign elements. Not more than 1.0 per cent Loss on drying Maximum 12.0 per cent, determined on 1.000 g of the powdered drug by drying in an oven at 105 °C for 2 h. Not more than 12.0 per cent, determined on 5 g of powder drug by drying in an oven at 105°. Total ash Maximum 12.0 per cent. Not more than 14.0 per cent Ash insoluble in hydrochloric acid Maximum 2.5 per cent. Not more than 2.5 per cent. Microbial contamination. Not given Complies with the microbial contamination tests.