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\{inarikova ul. t,
2ffi0 MariborPre.iel: FU'}S DIiitGC
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Farmacisti Associati
Prodotto-Product 1861 POT
Lotto - Batch Number R1402239
Produttore-Manulacturer JUNGBUNZLAUER'Gorrtanla'
Data rititolaziono - Retest date:0110712018
Pag.1 of 2
Tre dlvlslonl, un'unita dl lntentl. Produrre quallti.Thrce Deportments. a unlque will: Produce Quollty.
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SCHEDA TECNICA
]ooro.or,Rffi FARMALAB'*@ FARMALABoom
CERTIFICATO Dt ANALISI - CERTIFICATE OF ANALYSISE 332III PH. EUR.. USP . POTAS$IUM G]TRATE E 332IiI PH. EUR. . USP
TECHNICAL DATA SHEET
PRODOTTONOME CHIMICO
NUMERO CASFORMULA MOTECOI.ARE C6H6K3O7. H2O
PESOMOLECOTARE 324,41
slNoNlMl
TIPO OI PRODOTTO EDIMPIEGO
ALLERGENI
ASPETTOCOLOREODORESOLUBILITA'CONSERVAZIONE
PROPRIETA'
APPLICAZIONIDOSI CONSIGLIATE
ANALISIMATERIA PRIMA
POTASSIO ClTRAro E332 (ili) USP; PH. EUR.
Citrato lripotassico monoidrato
6 1 00.05-6 (monoidrato)
PRODUCTCHEMICAL NAME
CAS NUMBER
MOLECUTAR FORMUIA
MOLECULARWEIGHTOTHER NAMES
TYPE OF PRODUCTANDUSE
ALLERGENS
APPEAMNCECOLOURODOURSOLUBILITYSTORAGE
PROPERTTES
APPLICATIONSRECOMMENDEDDOSAGE
RAWMATERIALAMLISYSAssAY-nrp:ioo,sit
POTASSIUM CITRATE E332 (IIl) USP; PH. EUR.
Tripotasslum citrate monohwrate
6 100-0&6 (monohyd(ate)
c0H5K307.H20x24,41
Tripotassium 2-hydroryplopane-1,2,3-tricarboxytatemonohydrale; E 332 (iiD: Kaliicilras monohydricus
Food grade
Free from allergens lis{ed in Annex tlla o, oir-
2003/8oiEc
Glulen freeLatex.tr€e
Crystals ot grsnular powder
From colorless to white
Odourless
Very solubte in wate(, very sllghtly soluble in alcohol
Storo ln tightly closed contalflets
Keep away from lhe ala
Keep protected from moistureSequestrantPolasslum citrate has alkalising properties slmllar tosodlum bicarbonate. ln lvhich it Is ,apidly convetted by
oxldatlonStabilizerButfer
It is used ln tood lndustry
Potasslum citrats monohydrate is adminlstered orally at a
dose ol lo g/day in divided doses. O,al solufions of this
salt should be laken welt dituted with waler andprefelably afler meals
,,.SPECIF,ICATIONS RESULTS
Tnpolassio 2-idrossipropan-1.2,3'iriealbossilatomonoid,ato: citrqto tdpotasslco; E 332 (ilU
ldoneo all'uso sllmentare
Esente da all€rgenl tlportati nellAllegato lll bis dolla Dir.
2003r89/CE
Non contiene gluUne
Esente da lallice
Cristalli o polvere granulare
Da incolore a bianco
lnodore
Molto solubils in acqua, molto poco solubile in alcool
Conseruard in contenitod ben chiusl
conseNsre al flparo dall'aria
Conservare al riparo dall'umlditaSequestrante
tl potassio cikato ha propdetA atcalinizzanli analoghe a
guelle del sodio bicarboilato, nel quale vlene rapidamenteconvertito pea ossidazlono
Stabilizzante
Modulatore di pH
Usalo nelllnduslna alimenlare
ll potassio citrato monoldrato vlene Somminiskalo per viaorale alla dose di t0 g/dle suddMsl in plo
somministrazioni. Le soluzloni orali del sale vannoassunte ben diluite con acqua e protstibilmente dopo I
pastl
sPECtFtCr{E RISULTATI
TITOLO
IDEN'TIFICAZIONE
ASPETTO DELI.ASOLUZIONEpH
GRANULOMETRIA
PERDITAALL'ESSICCAMENTO
UMIDITAMETALLI PESANTI
sqo-100,5%Contenuto in polassio:35,6-36,2%
ConformB
limplda e lncolore
7,5-9,0 (5%)
Roslduo Eu 30 mesh (> 0,60mm) <= l0%Passante attravetso 70 mesh 3,5%(< 0,20 mml <= 15070
4-6rlo
4.6% (K.F.)
Hg <= 0,5 ppm
As <= 1 ppm
Pb <= 0.5 ppm
$a,2%36,1%
Conforme
Conforme
8,88,50/o
5,67c
6,6%
Conforme'Conrorme'Conforme'
IOENTTTY
APPEAMNCEOF,SOLUTIONpH
PARTICLES SIZE
LOSS ON DRYING
WATER
HEAVYMETALS
Polassium ernt€nI35,6-36,2%
CompliesClear and colourless
7,&9.0 (sol. 570)
Residue on 30 mesh (> 0,60mm) <= l!o7o
Passing lhrough 70 mesh (<0,20 mm) <= 16%
4-6'/o
4-67o (K.F)Hg <= qS ppm
As <= 1 ppm
Pb <= 0,5 ppm
100,2%
36,1oh
ComptiesComplies
8,88,5%
.3,54/o
5$%
6,690
Complies'Complies *
Complies'
FARMALABOR 5IIHead office Via Pozzillo, zona ind. - 75012 Canosa dl Puglia (Bt) - ltalyLegal head office Via 0berdan. 52 ' 75012 Canosa di Puglia (Bt) - ltalyReptesentative office Vla [avriana, 3 - 20134 Milano (Ml]' ltalyCod, Fisc. e Partita lva - VAT n'95676410722
PhoneFaxFaxE-mailWeb
+19 0883 611 301
+39 0883 664 824800 [email protected]
La qualll. aziendale€ dtonolciute d.lle aertitlcazlonltomgBny qualib/ 19 gurranteed
through follo*lng te.liFcatlontlS0 9001r?008l5o 14001t2001
Data dl aoorovazono - Date ofaDDroval 18,03.2014
/
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ATgl
q-,?-.sF
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rL
Pag,2 of 2
Tre dlvisionl, un'unlte dl lntentl. produne qualltA.Three Depoftments, a unlque will: produce Quolity.
Farmacisti Associati
SOLFATI <= lggppmCLORURI <= l5ppmSODIO <= 3QggppmACIDrAYALCAL|N|TA' ConformoSOSTANZECARBONIZZABILI
IMPUREZZE
ppmIMPUREZZE ORGANTCHE ConformeVOLATILI
ANNOTAZIONI
ANALlsl r ,r ...,,: ., .. ...'. : : ....,.,.).t .:. ;.t..:.:.:.: i...:MATERTA pRTMA spEcrFrcHE , iisur.inrr
':. " ':METALLiFEsANn-T;iai<= 6 ppm-A--------
FARMALABORffi FARMALABOO@
RAWMATERIALANALISYS "'': SPECIFICATIONS
FARMALABOR
RESULTS<=5<= 100<- 15<= 3000
Complies'Complies
Conlorma Contorme
Tartrali: conform8 Conrorme.Acldo ossallco/ossalau <= ioo Confo,me *
<= 100<= 15<= 3000
Conforme'
Conrorme'
HEAVYMETALSSULFATESCHLORIDESSODIUM
ACIDITY/ALCALINIW
READILY CARBONIZABLESUBSANTANCES
IMPURITIES
VOLATILE ORGANICIMPURITIES
NOTES
Tolal <- E - -.-'-
<= 100 ppm<= 16 ppm<= 3000 ppm
CompliesComplies
Tafuales: complles Complies.Oxalic acld/oxalalos <= 100 Compties *ppm
Complies Complies'
GERTIFICATO DI ANALISI . CERProdotto ' Product 186{ PorAsslo clrRATo E 3g2iit pH. EUR. - usp - porAsstuM clrRArE E 332til pH. EUR. - usp
Lotto - Batch Number R{402239
Produttore.ManufacturerJUNGBUNzLAUER-Germania-
Data ritltolazlone . Relest datel 01/0?I20ig
NOTE
FARMACOPEE
'Analisi effeltuale a campioneConforme a FCCConforme al Reg. UE 231t2012ALTMENTART)
Esente dal rischio BSE/TSENon Irattato con radiazhnl lonlzantlConforme a Ph. Eur. ed. vlgentoConforme a U$p ed. vigente
(ADDITIVI
NOTES
PIIAR TACOPOE[6r
"Analysls have been canied out randomlyComplias with FCCComplies with EU Reg. 231/20i2 (rood addiuves)
8SE/TSE f(eoNot treated with ionizing radialoneComplies with Ph. Eur. cunent ed.Complies with cunent USp
L6 specifiche sono statsopra riportato non vr esonerano d€rt'obbrigo di identificare e
"ont ott.r" il prodotto
!ly-^d:l y:g:,!:"dozione dei.prodoui e ui conseguen;; ird;r.ib;dii;ffisono 9otto ta lotale responsabitit. dell'utilizzalore-
gxgmo-tign from rdonrifying and rnspecring Ihe product before its use, ttre tinir-useibeing fully responsible ,or lhe adoption and lhe corecl usage of the producl
Direttore teonlco / Technlcal dlroctorpr. GlovannlSummontoA-iil/-*; f,**.*..-l-O
FARMALABOR STI
Head offire Via Pozzlllo, zona ind. - 7501? tanosa di puglia {Bt} - ltalyLegal head office Via 0berdan, 52 - 76012 tanosa Oi puglia dti _ ttatiReprasontative office Via Cavriana. 3 - zO13+ Milano (1,i0 - itaiy
PhoneFax
Fax
E-mailWeb
+39 0883 511 301+39 0883 564 824800 085 708info@farmalabor. itwww,farmalabsr.lt
La q!allti azlsodalea rlcodos(luta dalle aedlfirazionl(ompany qualit/ is gurraf,iecdthrough l0ll0$lng rertin(ations1509001!2008lS0 14001:200s
!g!, Flsc e Partlta lva - VAT n.05676410122Data dl approvazone - Date of approval 'tgO3.ZOl+
