H .

:
'' )"hi
r r 'i:#
s"tlK$$Tt fl il* it th.

rr stgrc t4us ada

Certificate of analysis
iE6e'a\{}r'r

ct : EXTR. HEDERAE HELICIS E FOL.

SPIR. SICC. (1 00o/o NATIV)

n
/J'.!N.

ITEM NO. 01 50340 -

-.fl ':tli
a:t
?..L
-{4
q:f
'.:+
E':.+r

.,s'a6 t{, .rt'

::s

BATCH NO. 1 60 1411 14 *tL \t

iL
&+.itSH+JL
*',t+r,.S

Y.t
a?^

DATE OF PRODUCTION 12.10.2016 t!-

..+tr.
'j-'i^'Y'+^
brfi
'.':f<r
iii1+

'4a$i't
"t3'-$

DATE OF RELEASE 09.1 1 .2016 :!;a

,!.:.{,t-.
+!l 'tl.
it
fil*-
-.dJ

--:Sl;' 'r't::.. ''ii

-.ETEST DATE 12.1 0.2019

j't
rJ ".1L

,*b^
: in '+*
iS '&*.
.K '.Fg*

F..rO9UgtiQ[.,Pala .
".fu*i"E

BoTAN |CAt'PART(S) USED HEDERAE FoLluM PH.EUR. *,.-.ddm;.u 's4'

.t::l Be""h#
ETHANOL 30% (M/M) '* il**
u" "

tr-*bil'uc-r'rj'iio M Erungq$-te-ffi "/o PH. E u R.

WATER FOR PREPARh?IoN OF EXTRACTS PH.

EUR,) .q!1
#:
'' '
'''B^

RATIO OF HERBAL DRUG TO 4.8:1

s-
*,q-B*;-T$ ": " i

.
_dw*"
E
"r-a .' '
.raf

DRUG PREPARATION *'W*.u&d

*f.\ "*4.
-q," '-Fa

(= NATTVE EXTRACT) .irB

"+dr#
I

:, ;flalh "4r*
r.?*a.f+ {Fr$

COMPOSITION OF THE
: ,''
.'* THS t$'A DRy ExTRACT WITHOUT EXCIPIENTS
&d''
,e '*-d-4i,.
EXTRACT PREPARATION .
. ]rrla
'+* .il:
'-fq.
tv-..

"'
df

?HlflH,?ltu
QHARACTERS
-ff%
ffiEk-*Y[E
; BRoWr.riSH PowDER
Results
COMPLIES

\--
:VE > 0.315 MM l"/,1 -3.;oS.F'*
flB :qB
a t,o'' r..
; ivlAx. s 0.6
''i{-'* '::*:"'+E
BOTTOM OF SIEVE l%1 * .d%E. ; MlN. 95 99.4

Loss oN DRYING l%t

-- ' - - 'r'df,**'*b#* ,.
; MAX.S 4.2
ACC. TO PH. EUR.(affi.17)
..,}i

NOTE tq,ft w*ETTT.ExCEEDING LOSS ON ORVING WATER

F: q{r-

.sj
rriir)rt

.rqorjg*i*n -.4*.,,r..f
"'i;L
"..t;'tt
CONTENT
,
..:,..it,'4t4
tr}"
r":'
lii wir-r- BE DETERMINED ACC. To PH.EUR. 2.5.12
.,,'- ti'n.o'tfl
rar"+:a
g ,a\n
.i7 +r (KARL-FISCHER). WATER CONTENT lN
-'i''.::ii:'

''ih
-;.1t1.:t
ri' .9.
,L .r,.F
PRINCIPLE
"+ +....i1' ?,tir
{-

.i+r.B.
'g.t
1i:i

'}RL HAS TO BE < 5%.

'n

BATCH SPECIFIC DETERMINATION 540

Martin Bauer Plantextrakt

Finzelberg:GmbH & Co. KG Komplementflr: Gesch6ftsf0hrer:

Koblenzer Str. 48-56 '56626 Andernach Finzelb6rg Verwaltungs GmbH Albert Ferstl
c;ffi;t .1el::+49 26g2924-00 ' Fax: +49 2632924-040 Sitz: Andernach Peter Wolfgang Schmidt
Sitz: Andernach Amtsgericht Koblenz HRB 12325
Amtsgericht Koblenz HRA 10177 www. marti n-bauer-group.com

1t3
 Product : EXTR. HEDERAE HELICIS E FOL.
sPlR. slcC. ('l 00r/o NATIV)

,y^,l'+-
ITEM NO. 01 50340 -r-! 'ra
',i\t
fvr
_!r,+.
'lfrr,,il'fl

:)r'it-!r 'E:- .r!f,'

&...+"'

BATCH NO. 1 60 141: 14 ",8,

'i.f,1p:,tpo 1Sa.1pill
$& "+
-{,1 4i'"i-'ai}

DATE OF PRODUCTION 12.1 0.2016 $ 'iR.

'o-t:' rv
.if;'

'a&
a\. $
.x
,iD

DATE OF RELEASE 09.1 1 .201 6 +

-.st:k. .r:r
{d *h-i (f"
.1

or-.TEST DATE 12.1 0.2019 s' 4h

1r

rl

Quality Data Specification Results

RESIDUaL'SOLVENT l%1 MAX. 0.5
ETHANOL
n0c:''fo MrrHoD FINZELBERG (Gc) :
dq
?-WI
"qil#*o

PYR R OLIZID I N E ALKALOI DS ; BArcH sPEClFtc DEffihloN < 0.01

AND N-OXIDES TPPMI '+
ACC. TO PL-SOP 805521 (LC-MS/MS) rE-,-B
:

TOrAL ASH [%] ; BATCH SPECIflfuETERMINATION

*u'+. E+
'*t'+$'
8.0
ACC. TO PH.EUR. (2.4.16) +*-ru*,bH.,**
*.
IDENTITY : HAs T-"#-#dMPLY
.,$* Y#
COMPLIES
TLC.FINGERPRINT 6r'u 'Rtr{JF
f.f'."v'
:i.rr +,S-'"4h, "4.
ON].SAPONINS ti. *'{f*+.

=4*
#s -&*a*S
'th,.xb\"
ANALOGOUS DAC 2OO4
(MONOGRAPH "EFEUBLATTER") ,$,+,
%-

": BATCH SPECIFIC DETERMINATION 12.4

flgltlrflA.rni,n /HDr n\
'-t...::th
F{.EDERACOSIDE. C (HPLC) ,.-.,.-'.:q

jC.
TO H. WAGNER ET AL- DT,:6,.G'H:*
-
nporH.zra. r zo,zor 3, e8?,-tffiff) 1

M rc RoB loloc ICAL E)#tv[,[MrI oN : HAS,TO COMPLY WITH PH- EUR. 5.1.8 B COMPLIES
ACC, TO PH. EUR. (fr*o.s'a 1

TOTAL AE ROBIQ'I-.U IC ROB IAL CO U NT : MAX" 50000 I

<10
(TA M C ) tC F q/#i1,J""i-rys

rorAl''qH,[ftH1-i{ E D YEASTS/MO U LDS CO U NT ; MAX.500 <10

(rYMiGffi[#FU/GI

...
*Bfl=iE TOLERANT G RAM.N EGATIVE ; MAX. 100 <1
-{i61"EA'bT
ER r A tc Futcl
%

ST}$*PtHffiR
15 G8 17 0r Erg n q ftrr sqaq
aoa'.*t&railT*toat00l

213
 Product : EXTR. HE-DERAE HELICIS E FOL.
SPIR. SICC.(1 AA/" NATIV)

n'"\-
ITEM NO. 01 50340
,*l+,.r.r '{ilayr i$+
,.i
^ql*
BATCH NO. 1601 41t14
%"k\-H -
'1,1:-
olr:r, $F<.11.
..7.

's-."-

DATE OF PRODUCTION 12.1 0.2016 :l'at. lrftr,rt

:+..:L,
,."r. tit+#".rv
$'
or3,i. 'i'f-:''
DATE OF RELEASE 09,.1 1 .2016 ,,ii r:'-afa+.+
1{..4*
:ir
ot'''t?" '&i
-.,J,.=
tr}.tr.TEST DATE 12.1 0.2019
,1

Wi ''' Specification Results

ESCHERICHIA.COLI/ G ABSENT COMPLIES

SALMONELLA I 25 G ABSENT COMPLIES

AUTHORIZED:

rt'
DR. HERMANN KURrH *t%
;AD oF QUALITY coNrRoL, FEWEERG
\s *{&*'
rHrs, rs A corrrr=*qsn$&r, oF rHE cERrtFtcArE oF ANALYS'' AND ts
wruour stcNATUflE.Yne stoNeD oRIGINAL ls oN FILE. 'ALID
.-,':.ir...
iar .'i+.
-!- '4. 'i:,Y
l:s_
+{.- 'iio-.i4:''k
-Por

''#tE'i*' '''ljit+
if:
tf5"

'+t- '-t1,.
,'.*.*
-"h':""''#Y; ..,$
.rttl*-
"s- 11*
'-1i+ q?^,-
'YY;
-,f1:
1'.,1 'i-I;?"

ffi#fftrLsffif,*
'+t
.ii:+r

-+ 'rr*1. .+
J.r''r: :?&-...{i+'
.!r-' Ii-. -<.:,,1

-]j:, ^rr
tn qi '$i ";t':f'

.iij' rili:i.
'.{$.,'1i:..+
-t::.'
i:ii- ''tf.t
-.,-::ii
.:lil
i::t

3/3