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eTHiCaL DruGS LTD.

SIDDHIRGANJ, NARAYANGANJ
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

Title : SPECIFICATION OF ELOCEF 500 CAPSULE

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

03. AVERAGE FILLED WEIGHT : 536.0 mg  1.0%

04. UNIFORMITY OF WEIGHT : As per BP

05. AVERAGE WT. OF SHELL : 86.0 to 106.0 mg

06. LOSS ON DRYING : 2.0% to 3.0%


07. DISINTEGRATION TIME : NMT 30 minutes
08. LEAK TEST : Should be 100% leak proof.
09. PACKING : 4  6’s Alu/Alu Blister Strip in a box.
10. STORAGE : Keep in a cool and dry place protected from light.
11. STRENGTH : Each capsule contains Cephradine BP 500 mg

12. ASSAY : 90.0 to 110.0% of labeled amount of Cephradine

…………………… …………………… ………………………


Written by Checked by Approved by
QC Officer Sr. QC Officer QC Manager
Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP018 FP018 01.01.17 01 1 of 3

Title : TEST PROCEDURE OF ELOCEF 500 CAPSULE

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. AVERAGE WT. OF SHELL : 86.0 to 106.0 mg


Collect 20 shells randomly, weigh and record. Calculate the
average weight as follow:
Total weight
Average weight = -------------------
Number (20)
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP018 FP018 01.01.17 01 2 of 3

Title : TEST PROCEDURE OF ELOCEF 500 CAPSULE

06. LOSS ON DRYING : 2.0% to 3.0%


Open 10 capsules and mix powder. Take 1 gm of powder and determine
the LOD at 105º C by using a Digital Moisture Analyzer.
07. DT : NMT 30 minutes.
Apparatus: Tablet Disintegration Test Machine
Introduce one capsule into each tube, add a disc to each tube. Suspend the
assembly in the beaker containing water, maintained the temperature at
37 ± 2°C. Operate the apparatus for the specified time. Remove the
assembly from the liquid. The capsules pass the test if all six have
disintegrated.
08. LEAK TEST : Should be 100.0% leak proof.
Submerge 5 Strips in water containing 0.2% w/v methylene blue
or any suitable color in leak test Apparatus. Maintain the strips
below the surface of water by means of a suitable device such as metal
disc or desiccator shelf. Apply the vacuum of 380 mm of mercury for
at least 2 minutes in the desiccator. Release the pressure slowly ﴾taking at
least 30 seconds﴿ and take out the strips. Wipe them to dry with clean dry
lint free cloth or tissue paper. De-foil the blister strips and observe for
blue spots/moistness/water inside the pockets.
If blue spots / moistness or water is not found inside the pockets, strips
are passed for the test.
09. STRENGTH : Each capsule contains Cephradine BP 500 mg

10. ASSAY : 90.0 to 110.0% of labeled amount of Cephradine


ASSAY : BY HPLC
PROCEDURE:
01. Mobile Phase:
Prepare a mixture of water, ethanol, 0.5 M sodium Acetate and 0.7 N Acetic Acid
(782 : 200 : 15: 3). Filter the solution through a membrane filter of 0.2 µ.
02. Standard Solution:
Dissolve 20.0 mg of Cephradine Working Standard in Mobile phase and dilute to 100 ml with the
same solvent and filter the solution through a membrane filter of 0.2 µ.
…………………… …………………… ………………………
Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :
eTHiCaL DruGS LTD.
SIDDHIRGANJ, NARAYANGANJ
TEST PROCEDURE OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/STP/FP018 FP018 01.01.17 01 3 of 3

Title : TEST PROCEDURE OF ELOCEF 500 CAPSULE

03. Sample Solution:


Dissolve powder equivalent to 20 mg of Cephradine of the mixed contents of 20 capsules in
mobile phase and dilute to 100 ml with the same solvent and filter the solution through a
membrane filter of 0.2 µ.
04. Chromatographic System :
a. Column : 4.6 mm x 250 mm, Packing L1
b. Detective Wavelength : 254 nm
c. Flow rate : 1.25 ml/min

d. Injection volume : 2 × 100 ml


e. RT : 9.0 min (about)

f. RSD : NMT 2.0%

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

…………………… …………………… ………………………


Written by Checked by Approved by

QC Officer Sr. QC Officer QC Manager


Date : Date : Date :

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