ANHYDROUS GLUCOSE SOP


ANHYDROUS GLUCOSE SOP

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:
Sr.#
Blank solution
Temperature
Optical rotation
(α)












                                                                                                 Average: _______________
Optical rotation of blank solution: _______________
Sample solution:
Sr.#
Sample solution
Temperature
Optical rotation
(α)












                                                                                                 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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