MEMANTINE HYDROCHLORIDE SOP

1.0  OBJECTIVE:
To lay down a procedure of analytical report for raw active material of the Memantine hydrochloride from the Pharmacopoeial specification.
2.0  SCOPE:
This SOP shall be applicable in Q.C laboratory.
3.0  RESPONSIBILITY:
3.1  Q.C Analysts.
4.0  ACCOUNTABILITY:
4.1  Q.C Manager.
5.0  PROCEDURE:
5.1  Identification tests:
5.1.1        Chlorides test:
5.1.1.1  Material and equipment:
5.1.1.1.1        Centrifuge machine.
5.1.1.1.2        Diluted nitric acid.
5.1.1.1.3        Purified water.
5.1.1.1.4        Silver nitrate.
5.1.1.1.5        Ammonia.
5.1.1.1.6        Excess of 6N ammonium hydroxide.
5.1.1.2  Sample:
5.1.1.2.1        2.0ml of chloride ion in 2.0ml of purified water.
5.1.1.3  Method:
5.1.1.3.1        Take a test tube add in it test sample with the help of pipette.
5.1.1.3.2        Add silver nitrate. Observe the changes.
5.1.1.3.3        A white, curdy ppt is formed that is insoluble in nitric acid but is soluble in a slight excess of 6N ammonium hydroxide.
5.1.1.3.4        When testing amines (including alkaloidal) hydrochlorides that do not respond to the above test, so take test sample containing about 2.0ml of chloride ion in 2.0ml of purified water in another test tube.
5.1.1.3.5        Add one drop of diluted nitric acid and 0.5ml of silver nitrate.
5.1.1.3.6        Observe the changes.
5.1.1.3.7        A white curdy ppt is formed.
5.1.1.3.8        Centrifuge the mixture without delay, operate centrifugation machine, according to SOP No. BM/QCEO/SOP010-00.
5.1.1.3.9        Decant the supernatant layer.
5.1.1.3.10    The obtained ppt is wash with 3 1ml portion of nitric acid solution (1 in 100), and discard the washings.
5.1.1.3.11    Add ammonia drop wise to this ppt.
5.1.1.3.12    Observe the changes.
5.1.1.4  Observations:
5.1.1.4.1        It dissolves readily.
6.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

7.0  REFERENCES:
7.1  USP38NF33 Volume-5 Official Monograph/Memantine hydrochloride: 2015, pp.: 4238-4240.
8.0  ANNEXURES:
8.1  Not Applicable.




9.0  ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Sr.#
Serial number
Q.C
Quality control
QCA
Quality control active ingredient
F
Format
Vol
Volume



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