ISPAGHULA
HUSK SOP
1.0 OBJECTIVE:
To
lay down a procedure for the active raw material of the Ispaghula husk from the
Pharmacopoeial specifications.
2.0 SCOPE:
This
SOP shall be applicable in Q.C laboratory.
3.0 RESPONSIBILITY:
3.1
Q.C Analyst.
4.0 ACCOUNTABILITY:
4.1
Q.C Manager.
5.0 PROCEDURE:
5.1 Loss
on drying:
5.1.1
Material and equipment:
5.1.1.1
Glassware (1
pipette, 1 spatula, 1 Graduated grounded-glass stoppered cylinder).
5.1.1.2
Analytical
weighing balance.
5.1.1.3
25.0ml of purified
water.
5.1.1.4
1.0ml of alcohol.
5.1.2
Sample:
5.1.2.1
0.1g of the
powdered herbal drug.
5.1.3
Method:
5.1.3.1
Weigh 0.1g of
sample by using analytical weighing balance.
5.1.3.2
Take a graduated
grounded-glass stoppered cylinder, put sample into it.
5.1.3.3
Moisten it with
1.0ml of alcohol by using pipette.
5.1.3.4
Add about 25.0m of
purified water and close the cylinder with its stopper.
5.1.3.5
Allow it to stand
for 4 hours.
5.1.3.6
Note the initial
volume attained in cylinder.
5.1.3.7
Shake vigorously
every 10min for 1 hour. And after that allow it to stand for 3 hours.
5.1.3.8
At 90 minutes
after the beginning of the test, release any large volumes of liquid retained
in the layer of the sample and any particle of the sample floating at the
surface of the liquid by rotating the cylinder about the vertical axis.
5.1.3.9
Measure the volume
occupied after every hour by the sample.
5.1.3.10 Note
down volume in annexurer-1.
5.1.3.11 Carry
out 3 tests at the same time.
5.1.3.12 The
swelling index is calculated by using formula:
Swelling
Index (%) = final volume after swelling – initial volume before swelling
x 100
Initial volume before
swelling
5.1.3.13 The
swelling index is given by the mean of the 3 tests
5.1.4
Observation:
5.1.4.1
Minimum 40.
6.0 REVISION LOG:
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Revision No.
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Effective Date
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Reason
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|
00
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New SOP
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7.0 REFERENCES:
7.1
The British
Pharmacopoeia. Vol IV.,
Official Monograph / Ispaghula
Husk: 2015, pp. 226-227.
8.0 ANNEXURES:
Annexure 1:
Observation and calculation of swelling index test.
Annexure:
1
Observations
and calculations of swelling index test
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Swelling
Index Test
Mean swelling
index (%): _______________
Calculation:
Swelling
Index (%)= final volume after swelling – initial volume before swelling
x 100
initial
volume before swelling
Result:
_____________________
Remarks: _________________________________________________________________
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9.0 ABBREVIATIONS:
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Abbreviation
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Expanded Form
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|
SOP
|
Standard
operating procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
QCA
|
Quality
control active ingredient
|
|
F
|
Format
|
|
Q.C
|
Quality
control
|
|
Vol
|
Volume
|
|
%
|
Percentage
|
|
g
|
Grams
|
|
ml
|
Milliliter
|
|
mg
|
Milligram
|
|
B.P
|
British
pharmacopoeia
|
|
R
|
Reagent
|
|
H
|
Hours
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