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. CERTIFICATE OF ANALYSIS
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Forrnat No. : A/Fl1 5/QCD/1 51/03'01
SOF h{o. , OftnPfneD/QCDiX5'!

[,{arne of the Froduct Flumequ ine Fh.Eur.

tsatch No. 21{23URMl
Batch Size : 632.00 Kg
FP12213121
A.R.. No.
Mfg. Date : Nov.202{
09t1212021
Date
Date : Oct.2026
Results
Tests spe cifications
ne powde r Conforms
A p p earan ce A wh ite o r al most wh ite m cro-crystall
SO lu ble n Conforms
So u bil ity P ractically in solu ble n water free ly
parl ng ly
d il ute S ol uti on S of al ka hvd ro xid ES, S
SO lu bte n methyle ne chl orid
a very sl rg hfl v
soluble in methanol.
Conforms
ldentification A. lnfrared abs orption sPe ctra ofte st and standard are
concordant
Conforms
B. lt comp lies with the test for optical rotation
than Conforms
Appearance of Solution S is clear and not more intense ly coloured
solution refere nce solution BYs
S is 0.024"
Optical rotation The angle of optical rotation determined on solution
o
- 0.10 to + 0.10 "
NMT O 50 o/o < 0.05 %
Related substances lmpurity A
NMT 0.50 % < 0.05 %
(By HPLC) lmpurity B
NMT 0.10 % < 0.05 %
Any UnsPecified lmPuritY
NMT 1.0 o/o < 0.05 %
Sum of lmPurities
0/o
Loss on drying Q.29
at 105"C for 3 h 0.06 %
Sulphated ash NMT : 0.1 %Ww
NMT 500 ppm 284.3 ppm
Residual Solvents Itlethanol
NMT 890 ppm 107.2 pPm
Toluene
o/o
99.7
Assay oo 0 o/o
1 0 1 0 % of C ra{tzF N Oe ( on d ried basi S )
ecifications.
: The above sam CONFORMS as er TS/BPC/U/C S/COS
red to Yellow Conforms
ldentification O. fhe colour of the test solution changes from
The colou r of the blank solution remains red

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PNEPRNTD BY
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MAN AGER QUAL ITY CONTROL

DATE I lt ltEzzP+
DATE: I o lt e-lza4

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