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SIDDHIRGANJ, NARAYANGANJ
SPECIFICATIONS OF FINISHED PRODUCTS
Dept. Document No. ID Code Effective Date Version No. Page
Quality Control QC/SPE/FP054 FP054 01.01.17 01 1 of 1
TEST : LIMIT
01. DESCRIPTION : A clear, lemon yellow colored, banana flavored syrup.
02. IDENTIFICATION : Test must be positive for Ambroxol Hydrochloride
02. IDENTIFICATION : The retention time of the major peak of the test sample should be
concordant with the retention time of the Ambroxol Hydrochloride
Working Standard as in the assay.
ASSAY : BY HPLC
PROCEDURE:
01. Buffer Solution pH 3.5:
Dissolve 3.50 gm of Potassium Dihydrogen phosphate in 500 ml of water and adjust pH 3.5 with
Triethylamine or phosphoric acid.
06. 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 Ambroxol Hydrochloride, in mg /5 ml
PU WS
= --------- ´ --------- ´ F ´ P ´ 5
PS VU
Here,
PU = Peak area of the Sample
PS = Peak area of the Standard