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:
Revision No.
Effective Date
Reason
00

New SOP

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
Swelling Index Test
Apparatus used:

Sample:

Reagents:

Time period:


Test
Initial volume
Final volume
Swelling index
(%)
1 hour
2 hour
3 hour
4 hour
Mean final volume
Test 1







Test 2







Test 3







Mean swelling index (%): _______________
Calculation:
Swelling Index (%)= final volume after swelling – initial volume before swelling x 100
                 initial volume before swelling




Result: _____________________

Remarks: _________________________________________________________________



9.0  ABBREVIATIONS:
Abbreviation
Expanded Form
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


No comments:

Post a Comment