This is Certificate Of Analysis of Famotidine 20 mg Tablet . Positive comments should be appreciated.

1. UNIVERSAL
UNIVERSAL Pharmaceuticals (Pvt) Ltd
Quality Control department
Finished Product Analysis Report
UNIVERSAL
Product Dosage form Batch No. Strength Study type Report #
Zemot Tablet 09015 20mg Finished
FT-876
Generic Name Batch Size Mfg. date Exp. Date Test on
Storage
Conditions
Famotidine 119,000 03-2018 03-2021 23-03-2018
Temp: 30 + 2o
C,
R.H: 65 + 5 %
TABLETS ASSAY RESULT DETAILS
Tests Specification Result Calculations:
Wt of 20 Tablets = 2.318
Avg wt of tablet = 116mg
Std Perp = 40mg x 5ml (in Buffer pH 7.00)
50ml 100ml
Spl Perp = 245mg x 5ml (in Buffer pH 7.00)
50ml 100ml
Peak Area of Std = 379130, 377347, 376994
Mean X = 377823.66
Peak Area of Spl = 403695,404126, 404058
Mean X = 403959.66
Mg of Famotidine per Tablet=
Peak area of Spl x Wt of Std x % Purity of ws x Avg wt of tab
Peak area of Spl Wt of Spl 100
= 403959 x 40mg x 5ml x 50ml x 100ml x 99.4 x 116
377823 50ml 100ml 245mg 5ml 100
= 20.13mg/ tab
%age = 20.13 x 100
20
= 100.63%
Limits = [ 90.00% ----- 110.00%]
Appearance
Light blue color
round shaped Core
tablet
Complies
Diameter 6.00 mm Complies
Identification
+ve for
Famotidine
+ve
D. Time
NMT 30Min min
sec
Dissolution
NLT 75% in 30
minutes
Assay 90 % -- 110%
Dissolution:
Medium ; pH 4.5, 0.1 M phosphate buffer (l 3.6
g/L of monobasic potassium phosphate; 900ml
Apparatus II; 50rpm
Time; 30 minutes
Remarks;
Tested By
Q.C Officer
Approved By
Q.C.M