Acebrophylline COA

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DE,LTA F'INOCIIE,M P\/T. LTD.


Regd. Off.
: Plot No.121, M.l.D.C. Area, Satpur, Nashik - 422 007., M.S. (lndia)
Ph. : +91 253 - 2350554,6645777, 236327 I
Factory : Gat No.-350, Village Wadivarhe, Tal. lgatpuri, Dist. Nashik - 422 403. M.S. (lndia)
Ph. : 02553-282800 I 282801 Email : sales@deltafinochem.in
deltafinochem@gmail.com O Web : www.deltafinochem.in o CIN : U24100MH2000PTC123980
c
Geotek Global
Cedilication Pd. Ltd.

ISO 9001 - 2015 Organization


. UAN : MH23C0002673

CERTIFICATE OF ANALYSIS
Product ACEBROPHYLLINE
of
Batch Quantity 23t.4Kg
Batch Number AB/r1/20062 Reference Inhouse
A.R. No. E20070020 Mfg. date July - 2020
Expiry date June - 2025
S.NO. TESTS OBSERVATIONS SPECIFICATIONS

0l Description White crystalline powder White or almost white crystalline powder


02 Solubility Complies Slightly soluble in water
Identification

In IR absorption spectrum of the sample


03 a)lR absorption Complies should be concordant with that of
spectrum obtained from Acebrophylline
working standard.
b)Melting range 213.5"C to 214.0"c 210.c to 217"c
04. Loss on drying 0.31% Notmore than0.5%owlw
05 pH 4.88 Between 4.50 and 6.00w/w
06. Heavy metals Complies Not more than 20 ppm
07 Sulphated ash 0.04% Not more than 0.10% w/w
08 Related S ubstance (B v HPLC)
a)Individual maximum 0.03% Not more than 0.20 %o
b)Total es 0.0s% Not more than 1.0 %o
09 Assay by HPLC
Ambroxol (ODB) 61.08% B etween 59.50% and 63.20 %o wlw
Theophyllin e -7 - Acetate
(oDB) 39.59% Between 37.50% and 39.80 o/owlw
Remarks: The Batch Complies as per above Specifications
Storage condition: Protect From Light

Prepared by Checked by Approved by


Sign
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Date a+lo8 /zou o7 /oe /;.^ o7l w20

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