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SOP for Performance Check of Automatic Distillation Apparatus


Standard operating procedure to evaluate the performance of Automatic distillation apparatus using ammonium chloride.

1.0  Objective 

       To define the procedure for performance of automatic distillation apparatus.              

2.0  SCOPE

       This procedure is applicable to Automatic distillation apparatus, installed in Quality control Department.    

3.0  Responsibility

3.1  Doing       : Technical Assistant/ Executive
3.2  Checking : Executive /Manager   

4.0  Accountability   

       Head of the Department

5.0  Procedure 

5.1  Check the performance of apparatus by recovery from ammonium chloride.
5.2  Recovery from Ammonium Chloride.
5.2.1  Take 1.0698 gm (+ 0.001 gm ) of ammonium chloride (previously dried at 105oC for 4 hrs.) in 1N H2SO4 and dilute it to 1000 ml with 1 N H2SO4
5.2.2  Take 5 ml of above solution in kjedhal tube for distillation.
5.2.3  Collect distillate in received solution and Titrate it against 0.025 N HCl using methyl red, until the colour change from green to pink. 
5.2.4  Calculate the recovery and record it in Annexure - I .

5.3  Frequency  : Once in three Month.       

6.0  ABBREVIATIONS

6.1  HCl  = Hydrochloric acid.
6.2  N     = Normality
6.3  gm   = Gram.
6.4  ml     = millilitre
6.5  H2SO4 = Sulphuric acid.
6.6  Hrs.  = Hours
ANNEXURE-I
QUALITY CONTROL LABORATORY
PERFORMANCE CHECK OF AUTOMATIC DISTILLATION APPARATUS                                     

PERFORMANCE DATE
DATE OF LAST PERFORMANCE DONE
NEXT DUE FOR
PERFORMANCE CHECK




INSTRUMENT DETAILS

INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.




OBSERVATION

Set –1                                                                                  Set-2

Taken Wt. of Ammonium chloride : ___________ gm Taken Wt. of Ammonium chloride : _________gm

Blank B.R  : __________ ml                                                 Blank  B.R :__________ ml

Test B.R    : ___________ml                                                Test B.R    : ___________ml
Difference : ___________ml                                                  Difference : ___________ml

Calculation  :
Recovery : b x d x 1000
b is ml of 0.025 N HCl
d  is normality of 0.025 N HCl
                     =  ______________ %                                           =  _______________ %

Acceptance Criteria : Average recovery should be between 98.0 % to 102.0%.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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