1.0 OBJECTIVE:
To
lay down a procedure for the active raw material of the anhydrous glucose from the Pharmacopoeial specifications.
2.0 SCOPE:
This
SOP shall be applicable in Q.C laboratory.
3.0 RESPONSIBILITY:
3.1 Q.C Analyst.
3.2 Q.C Manager.
4.0 ACCOUNTABILITY:
4.1 Head of the Q.C Department.
5.0 PROCEDURE:
5.1 Characters:
5.1.1
Appearance:
5.1.1.1 White or almost white.
5.1.1.2 Crystalline powder.
5.1.2
Solubility:
5.1.2.1 Material and equipment:
5.1.2.1.1
Glassware
(2 test tubes, 1 spatula).
5.1.2.1.2
Ethanol
(96%).
5.1.2.1.3
Purified
water.
5.1.2.2 Sample:
5.1.2.2.1
Small
quantity.
5.1.2.3 Method:
5.1.2.3.1
Take
2 test tubes and add small quantity of sample for testing solubility according
to B.P specifications.
5.1.2.3.2
Add
purified water in test tube 1 and observe.
5.1.2.3.3
Add
ethanol (96%) in test tube 2 and observe.
5.1.2.4 Observations:
5.1.2.4.1
The
sample in test tube 1 containing with purified water is freely soluble.
5.1.2.4.2
The
sample in test tube 2 containing with ethanol (96%) is sparingly soluble.
5.2 Preparation
of Solution S:
5.2.1
Material
and equipment:
5.2.1.1 Glassware (1 beaker of 50.0ml, 1 stirrer,
1 spatula).
5.2.1.2 Purified water.
5.2.2
Sample:
5.2.2.1 10.0g.
5.2.3
Method:
5.2.3.1 Take a beaker of 100.0ml and add 10.0g of
sample in it.
5.2.3.2 Dissolve it in sufficient quantity of
purified water.
5.2.3.3 And dilute it to 100.0ml with same
solvent.
5.3 Identification
tests:
5.3.1
Specific optical rotation:
5.3.1.1 Material and equipment:
5.3.1.1.1
Polarimeter.
5.3.1.1.2
Analytical
weighing balance.
5.3.1.1.3
Magnetic
stirrer.
5.3.1.1.4
Glassware
(1 beaker of 50.0ml, 1 stirrer, 1 spatula).
5.3.1.1.5
0.2ml
of dilute ammonia R1.
5.3.1.1.6
Purified
water.
5.3.1.2 Sample:
5.3.1.2.1
10.0g.
5.3.1.3 Method:
5.3.1.3.1
Take
a beaker of 100.0ml and add 10.0g of sample in it.
5.3.1.3.2
Dissolve
it in 80.0ml of Purified water and 0.2ml of dilute ammonia R1 by using magnetic
stirrer.
5.3.1.3.3
Allow
it to stand for 30minutes.
5.3.1.3.4
And
then dilute it to 100.0ml with purified water.
5.3.1.3.5
Firstly
clean the Polarimeter with clean dry cloth, according to SOP.
5.3.1.3.6
Operate
the Polarimeter according to SOP.
5.3.1.3.7
Fill
the Polarimeter tube with blank solution and determine the observed optical
rotation.
5.3.1.3.8
Similarly,
fill the Polarimeter tube with sample solution and determine the observed
optical rotation.
5.3.1.3.9
Note
down the values in annexure-1.
5.3.1.3.10 Calculate the specific optical rotation with
reference to anhydrous substance by using formula:
[α]λ T = α/lc
5.3.1.4 Observations:
5.3.1.4.1
The
specific optical rotation is -52.5 to -53.3 (anhydrous substance).
5.3.2
5.3.2.1 Material and equipment:
5.3.2.1.1
Glassware
(1 test tube, 1 pipette).
5.3.2.1.2
Analytical
weighing balance.
5.3.2.1.3
3.0ml
of Cupri-tartaric solution R.
5.3.2.1.4
10.0ml
of Purified water.
5.3.2.2 Sample:
5.3.2.2.1
0.1g.
5.3.2.3 Method:
0.1.1.1.1
Take
a test tube and add in it 0.1g of sample and dissolve it with 10.0ml of
purified water.
0.1.1.1.2
Add
3.0ml of cupri-tartaric solution R and heat it on burner.
5.3.2.3.1
Observe
the changes.
5.3.2.4 Observations:
5.3.2.4.1
A
red precipitate is formed.
6.0 REVISION
LOG:
Revision No.
|
Effective Date
|
Reason
|
00
|
New
SOP
|
7.0 REFERENCES:
7.1 The British Pharmacopoeia. Vol I., Official Monograph /Ephedrine: 2015, pp. 848-849.
8.0 ANNEXURES:
Annexure 1:
Specific optical rotation observations and calculations.
Annexure: 1
Specific
optical rotation observations and calculations
Specific optical
rotation
Instrument:
___________________
Date: _______________
Model:
_______________________ Length
of Polarimeter tube: ________________
Sample:
________________________________g.
Solvent:
________________________________ml.
Concentration
of sample solution: ____________g/ml.
Blank solution:
Average: _______________
Optical
rotation of blank solution: _______________
Sample solution:
Average: _______________
Optical
rotation of sample solution: ______________
Optical
rotation of substance = Blank solution - Sample solution.
Specific
optical rotation of sample solution by using formula:
[α]λ T = α/lc
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
|
g
|
Grams
|
ml
|
Milliliter
|
mg
|
Milligram
|
o
|
Degree
(angle)
|
l
|
Length
|
c
|
Concentration
(g/ml)
|
g/ml
|
Gram
per milliliter
|
α
|
Alpha
|
λ
|
Lambda
|
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