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IN-HOUSE SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP018 FP018 01.01.17 01 1 of 1
TEST : LIMIT
01. DESCRIPTION : A light blue OP/white OP ‘0’ size hard gelatin capsule filled with
white crystalline powder.
02. IDENTIFICATION : Test must be positive for Cephradine
01. DESCRIPTION : A light blue OP/white OP ‘0’ size hard gelatin capsule filled with
white crystalline powder.
02. IDENTIFICATION : The retention time of the HPLC chromatogram of the assay
preparation is concordant with the retention time of the Cephradine
Working Standard as in the assay.
03. AVERAGE FILLED WEIGHT: 536.0 mg 1%
Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Calculate the average weight as follow:
Total weight
Average weight = -------------------
Number (20)
04. UNIFORMITY OF WEIGHT : Weigh an intact capsule. Open the capsule without losing any part
of the shell and remove the contents as completely as possible.
Weigh the shell. The weight of the contents is the difference
between the weighings. Repeat the procedure with another nineteen
capsules. Determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than
10.0% and none deviates by more than twice of 10.0%.
05. Separately inject equal volumes of Std. Soln. and Sample Soln. into Chromatograph, record the
chromatograms and measure the peak responses for the major peaks. Calculate the content by the
formula:
Content of Cephradine, in mg /Capsule
PU WS
= --------- ´ --------- ´ F ´ P ´ Av. Wt.
PS WU
Here,
PU = Peak area of the Sample
PS = Peak area of the Standard
WU = Weight of the Sample
WS = Weight of the standard
F = Dilution factor
P = Potency of the Standard used in percentage
Av. Wt. = Average weight of the capsule