rh Phanmacpola Volume
encores Mada! nd Phomacaut Sbsinese
Ethyl Hydroxybenzoate Sodium el
‘coneral Notices
Ethybaraben Sodium
(Sodium ty Parahytoxybonzoae Ph Eu monograph 2134)
oe
Coto, 1002 5205008
Pew
DeFNTON
Sodiun +(ehoxeatonypherlae,
Content
£950 per conto 1020 per cont annyetous substance).
‘CHARACTERS
‘Appearance
ite osmost white, mygrosconc erstatine power.
Sotubity
Freel cuban waar, slit h antyéous ethan, pracsalyigoublein matter chord,
IenTiFicarion
Fist identification B, D
‘Second Kontiieation A, CD
|A. Discolve 0.5 gin 80 of wale nada ad 5 mf hycrchloi ac RY. Fite and wach the preciptate
wih water Dry nvacue at 80°C fx 2h. Rimes (22 14) at 118°C 18°C
'B._Infared absorption spocophotomoy (2224).
Proparation Tho recital caine in entiistion A.
Comparison hy! parhyshoxybenrate CRS.
(C.Thintyer cramatoqrany (2227)
Test solution fa)_DissoWe 0.100 ge te substance o be examined 10 mL of water Imlay ads? mL of
hyrostior aci Rana shako wth 80 Lf mayne chido R Evaporative auer layer to dynes nd ake up the
resid wh 10m of acelone
Test solution (2) Die tml of tastskain (ao 10 mL wih acetone
Reference solution (a) Dissolve Sg of thy parshyarobonzoale CRS in acetone Rand sito mL wt the came
saver
Reference solution (b)_issowe 8g of matty parahyeroxybenzoate CRS (musty Bn 0.5 motes soko 2)
‘on leo S mL wh acetone
amazon cape fst BAO -HBNTIONae ™ Oe oamtmuitetesitanen Son
Hobie phase glace act ais water R, methane (12070 VIVA,
Application 5.
Development Over 2 of te plete.
Drying ‘nai
Detection Examine i uli i at 254 nm,
‘System subi eference Staton
—the chromatogram shows 2 cal separated principal sat
Resuts Te principal spat in th erometogram obs wh let okon (is ear poslon an es othe
‘indpalepetn te chvomatogram obsinot wih rere elton ()
. To mb ofschion& c00 Test) add 4m of water. Th sluton gv ean a) of sed (2.
tests
Solution s
‘Dissove 8.0.9 carbon contre water prepare rm sod wate Rand dl to 80m wih he same solvent.
‘Appearance of solution
Solution 8, examined nme ate preparation, cles (22.1 ond nat mor inlenely slur han relrence
sohion BY (22.2 Matted I).
(223)
Diltet ml ef sluon Sto 100 mL wih carbon eases water.
Related substances
gut evomatography (2.220.
Test solution Dsslvo 80.0 go tho substance tobe examined in 2.5m of ethan Rand eo 50.0 wth he
mobile phse, Ole 10.0 mle he sation o 100.0 wh Sn mole ase
Refornce solution (2) Dsl 5g of ycrnyenzoe act R (input A), ng of meth paalyckonybonzote R
(party 8) ad 5 mg of he substance obs examined ine mate phase ard Suto 100.0 mL wth the mao aso,
into 10m of colutono 1.0 mt wh the mete pss,
Reference solution (b) Ossolv 50.0 mg of ety paratycoxybanzoate CRS in 2.5 ml of methanol Ran tt 60.0
‘own the mobile phase. Dita 10.0 mL ef the souten to 100.0 with tbe mabe pas,
‘Roforance solution fe). Oise 0 Lo he lt eokiton 0 20,0 mL wth he mie pase ilo #0 mt of tie coliton
‘0 100ml wih be mabe phase.
coun:
ste: 120151, = 4.8 me;
—stoonary phase: end-spped ocadcysy ilea go for ctvmatography FS
‘Mobile phase 6.8). schon of potassium aiyerogan phosphate R, meanal R265 WM,
Flow rate 49min,
Detaction Spectophotomeer a 2720,
Infection 10 ef ett sotiin ed
race solos (2) an).
‘Run tine 4 mes te reteton tine c ety parahyeronybencoats,
psn shrnserps coat SenRinnp.MaaoyacsOpuntnsnAieEenitench sapaot4 ta Paemciona 015 One
Felative retention wih eferorcots ey parehyeeeaybenzosto leone = about 8 win kp A = about 8;
impurity 8 about 0.
‘System stabi reference saluon
= reat: minerum 20 betwesn he ps due to mpury Banda parhyeroxybonoat,
Lins:
“= cone foto forth cleton of content, mutpy the peak are of input Ay 14;
— impuy not more than 6 isthe reo epics peak inthe cromalagram blaine wah ference
_sokien (3.0 per con
— unspocio impura: tr aac impurity, not ore than the reso the pail pk nthe crometugran ebtahned
wit relerence scion) (0.5 pe cat
= sumotinpusties otter than ot mere tan tes theses of he pircps!peokin the chvemaloram cbsinod wth
referees scion (2) (1.0 par cee
— ctsrepard ft 0.2 tno the 91280 the prin pek'n th ehomaogtth caine with reference solution fe (04
per ean.
Choridas (2.4.
Maximum 350 gem,
‘To 10. cf akin $a 90 mL of water Rand 1 mL of nie aidan ato EO mL wb water Ske an fit
‘its 10 mf ho aot 1 mL wh water Prepare to standard using amie of tml of water Rand 14 of
hte standard satan (5 pm CD %
Surates (24.19
simu 300 pm,
“To25 mol ston Sada 5 mL of tod watr Ras 10 mo Ryehoetloc aks Rand tet 0 wth tied
tor. Shako and ft. Oto Orato te fiat to 15m vith itd water
Heawy metas (24.8)
esi 10 po,
Diss 2.0m wator Rasta to20.0m withthe same saben. 12 Lf the eaufon complies wth st A Prope
Ute reference slain using lod stand soliton (tp PR,
“Tho suetanc pocptates afar adn of buorsoluion pH 2.6 De to 40 mi wth anys ethana the
tubsanoe eases compoly.
ter (2512)
Maxie 6.0 pr cont, detemined on 500
assay
Ligue cmt (2.225) 26 eosbes ne os fo lated substances wn ha alowing mosication
Injection Tes station and reference scion
Cctelte the pereniage conten of Claas tm te cectarod content of eh parhycronbanzoate CRS, multe
bys oxen actor of 1.192
STORAGE
{nan ah conan.
ImpuriTes
‘Specified impurities, &
thar detectoio npuntes (he ftong substances woud, I present te sulin evel, be detected by ono thr ef
‘he sts in tho monograph, They are rites bythe gaara aeceptanenererion fr abernepectod impos.
pa omacpaa cok end OpenziostA7ESMrasoch samaore a Pannen 208 nt
‘therfore not necssary to deny these impure for demonstration of canes, Seo ako 5.10. Cont of impute a
‘sunsancas fr phemmasoutea us) 8 C.D.
a
A. tytonybonzoe al,
. oe
8 methyl 4nycrombenzoate (mo rardhyoxyoonzate)
aoe
6. propy4tysroxybenzote (rp parahydronbenzoate),
oo
.
._ butyl 4nydenybenzoate (but arahyaroxybon2at).
Phew
(© rom Copyigh 2014
ips pharnacipecnzoihnt.iergoytreSopaRikre ieee “ Nong Mesnl andPhomacas Suton
Methyl Hydroxybenzoate i
oneal Natios
etiypraben
(Mots Poahytrononzoato, Ph Ew. monograph 0409)
wom
CettOs 1524 00-76
Action and use
otinierobi presoative
Ph Eur
DEFINITION
ety 4 nydroxfoarzoat
Content
{980 por conto 1020 par cant.
ccharacrers:
‘Appearance
Wit oralmost wit, entaina power or colores esta,
Solubity
ery sity sobein water, rely cle in ethan (86 por cont and in methane
IDENTIFICATION
‘rst identiicaton A, 8
‘Second identiestion A, ©
A. Mating paint (22.14): 125 “Cw 128°C.
B. ntoed absorption spactophotimaty (2228,
Comparison methyl paraychonybowoate CRS.
1G. Thnayerevomstowapty (2227,
Test solution fs} Cisse 0.10 g ofthe substance tobe examinednacatne and lta 10. wth be sae
salen,
Test solution (2) OaH0-1 mL of esteatston (210 10: wth seatone
‘Roferance solution) Dissolve 10mg of methyl parahyraybanzoate CRS a acatone and dist 10m wh the
‘Reference solution (b)Dieslve 10mg of ey parahytroxybonzoate CRSIn ‘mL of et ction (a) and it to 10
‘mL wth cote
psn homarposnca Aten shepard EUG CA-TActssrh ™ aoe ‘2 Pramas 2018 Oe
Pato TLC octadayly sea gl Fe plate
Mobile phase glacial acate acd R water R, methanol (130.70 VIM
Application 2 yo test soln (bane ference soslons (ane
Developmont Ove 2 ote plate
Drying nat.
Detection Examine butane Wt at 254 a,
‘Systm stably: foronce eaten:
=the cvomatagram shows 2 carly separated pripal spot
‘Results The pial atin the cromtogram obi wt fa ohon () is snarin poston an siz tothe
prinapal spt nthe cvomatgram cbains wit ference solute 3).
rests
Solon 8
‘isso 1.09 thane por con) Rand ltt 10 wit fhe sae svat
‘Appearance of solution
Soluion Salar (2.2.1) and na morintnsely colored than celerence soon BY (222, Method Il
Acidity
To 2m of slut Sal 3 mL of eae (86 por con) Ri, 5 mL of carbon cowde-ee water Rand 0.4 mk of romeresat
‘7m saluion FE. Nol more than 0.1 of 0.1 M sadam yo request change the colour of hander to be,
Related substances
ul chromotogopny (2.229,
Test solution Osslve 50.0 m9 of he subsance te examines in 2.5m of maton! Rand et 0.0 mL wth the
‘mobile phase, Disa 10.0 mL ofthis elation o 100.0 mL weh te mode ph
Reference solution (a) Dissclve Sng o4-ryoxydonole act gusty A) an 6 ma ofthe substan tobe
‘examinodintho mobo phaso and lt to 100.0 mL wth he rail paso. ule 1.0 oft soluen to 10.0 mth
Ine odie pase
‘eforenco solution (0) isso 500 mg of mehyparythoxyonzosta CRS in 28 mo mathanal Rand isto
‘50.0 ml with tho mbit po, Die 10.0 mF hs state fo 100.10 wh he mabe phase,
Reference solution). Die 1.01 of he es sion o 20.0 mi wth tho mob phase, OMG. moths chon
10 100 mt wih he mati phe,
stationary has: endcapped cadecsi sea gal fr ceometograpy (5 um,
[Mobile phase 6.8L sculon ef poussium dnyogan phosphate R, melhor R (95:65 VM).
Fiowrate 13min
Detection Specvopheiomater a 272 nm.
Injection 0 ofthe ost scion and reference solsons (a and).
Fun time Sines the retention tine fat parahycrongbenzoae,
‘Relatve retention hh reference le met parahysrontbenzoate (tenon ne = about 2. min: impurly A= about
08,
hemesopnncout\shbinbnre-dapayytycUSsnAleASeitsee, ‘Syst stabi torneo soliton 2}
= resto minimum 20 betwoun he pesks due to meu A and may parhyxonyanioat,
ts
~ correction fo: fr ho caleulon of onto, mulipy tho posk are of impuy A by 1.4
= Impurty nt moe than he area othe prical peak nto chvomslogam caine wih reference slaion (0.5
por cont,
—tnspeciod inputs: or each putty, no muse than We area ofthe en nek i the cromaogram obtained
‘wh eerence elton () (05 prea
toa ot more than ice the ea of principal peak athe cvoratogren ebained wh reerence slain (1.0
parent
laregar 0:2 tes the art fe rnp peak inthe chromatogram cbislad wih erence sla (c01
par con,
Sulatad ash (24.14)
asi 0.1 por cot, determined on 1.00
Assay
qui chromatoarerty (2.229) as described in th test read substances with he allowing medication.
Injection Tost soliton and eeterence eon 0).
Cate the percertge content of C0. ham the doctored content meth garafyeoxybenzote ORS.
mpuRITIES
‘Spectodimpuritios &
‘ine detectaieimpunts (te falowr substances woul, pretonta silent evel, be doce by ono or ober at
"teats the manogeaph They are kod by th goer acseiane eleron fer theunepecieg hues ado by
‘ho genera monograph Substances f pharmaceutical uso (2094). thereto nat necoeany to ently ese spurs
{or demansiaton of complancs. See als 5.10. Conte of mpurtos ht ststanon fr paracautial se) B,D.
L
10"
A. Ahydrnybonzole al,
ao
B. ety +hyronybenzoata thy forameroxyborzoat),
ow
pep aber ep naayontorzn)
eye
10
apa amecopan cn teh encapayNyipEUNBN-i-HSEbaa, wnoaoie th Presa 2015
‘ton Parma Vela 1
onographs: Medal rd Pharmacol Subsets
Propyl Hydroxybenzoate ey
aera notes
Promaaten
(Propy Parahyroxybenzoate, Ph. Eu monograph 0491)
. lomeen
Cotia0 1802 9613-9
Aetion ana use
‘Arterial poser
meu
DEFINITION
Prop 4hyonybenzooto
Contnt
(93.0 pecan 1 1020 per eon,
‘cHaRacTERS.
‘Appearance
Wt amas whi, cystine power
Sotuity
Very sight solboin water, ely souo ln chane (96 pr con and in ethan
Inewriricarion
First identicaton 8, 8
‘Second identification A, ©
[A Metin point 22:14): 06°01 890.
B. Inared absorponspeceophotmety (2224,
Comparison prop pratyaroxborzosto CRS,
G.Inmtayerenvomstography (2227)
Test solution fo) Diese 0.10 g oe easlance tobe exarnadin acne and ltt 10 wth he sme
salve
Test solution (2) Otte 1 mL ofstcouion a) 0 10 mt wth stone.
‘Reference solution(s) solve 10mg of pony parahycroxybonzoate ORS in acaton Rand dil te 10m withthe
‘sme shen
Reforonce solution fb) esol 10mg of ety! prahytonybenzoate CRSIn {ml oft soon (a) and ef 10
mk wih acatane Re
po cpa p05 endapyrNytneiso HT saeh ue "Spm Teh oh i R =
tobe pace ct a tena R078,
Apleston 2 ets rest) 50).
pant Ov 28 in
yng
Detection Exxnine i uavisa it a 254 nm
Systom eu. eerence soln
=the romatogiam shows 2 deat separte pencil apts
Results The rin pa inthe ercmstozam oad wh wa olulon (sion poalton ord oho
‘inp pot nthe chvamstogram ottaned wih ernie soutn (2)
rests
Soliton §
issotve 1.0 9m athanet (6 pa cont ale to 10 mL wth the aro solvent
Appearance of solution
Solvion St lot (22.1 anno roe ntnsoly clear than rleancesolilan BY (222, Method
Aelety
To 2ml of sluion Sad 3 lof etre (6 par con 6 mf coon donee water Rand 0.4 mi of ommeereso}
70m scion R, Not moro han 01a 0.1 sou Ryton segura change the calor a teeter ble.
Related substances
quit tromotography (2220,
Test solution Dssave 50.0 goto substnce tobe examina a 28m of methanol Rand eto 5.0 mk wth be
‘mobile phase, Ota 120 mL of is san o 100.0 mL wih tho moble pace
Reference solution a) _Disaiw 5 x9 of -hydnxybonot al (mpury A), 51mg o thy parahyekanybonzoato R
(impunity C) end mg ho suetnes obo exatnod inthe mobi phase aed to 100.0 mi wih he mobile phase
Dilute 07m ofthis sokon fo 10.0 a. wth ho mate pase
Referance solution (2) Dles'v0 80 mg of propyl parahytromonzoste CRSin 2.5 ml of methanol Rand his to
‘0. wh th medi phe, Oe 1.0 of he soon 100.0 mL wth the mb pase,
Reference soliton c) Oho 1.0 ofthe et slate 20.0 wh the mode phase te *.0 of selon
49 100 mL wih he motile pase.
— se: 04180, 9= 48.0:
= stationary hse: endcapped ectadecisiy sia gal fr chromatography (Sm),
[Mobile phase 6.0L soliton of assum dtyhagan phoephateR, matbonl (3565 VA,
Flow rate 1.amunin,
Detection Spectophetometer a 7m,
Injection 10 Lo he tastsaluton and eerance solitons (a) and).
Run time 25 tines terete ine of pop paahyéroxybazoat,
Relative retention Vist oleronce propyl arahyronyberzonefeteton tine = about 5 an nputy A sou
03; inpuny C= about 07.
pt amassed Ny br Sl 2b saat uo Parco 205 One
‘System subi reference slain
reson inimun30twoe he peaks duet puny an propyl parahyconyberzote
ite:
erection foto or th eset of content, mutiny the pk ae pay Ay 1
—Inpunty not moe tha the ve fhe principal peokin the cvemategram cise wih reference slain (c (0.5
par cot
—tmspeced impute: each input, ne mee han We aren of the pn pak nthe naga obtained
‘wth france sluon (05 percent
~ toot ot more an tue te eof he principal peak nthe chiomatogram ebiained wir eerence soliton (2)(1.8
percent
= ego in 0.2 times tho ofthe prnip! peak ne cheeatogram atainad wih earn soon (04
ar cont,
Suited ash (24.16)
asim 0.1 por cent, deterinod on 10 9.
assay
qui chromatography (2.229) a8 dosed inthe ot oad substances wih he folowing modification.
Injection Tes! ston and eforence skin 0).
Clete the percentage content of Cg20s am tn dare content cf propyparahystonybonzone CRS,
meURITIES
‘Specied mpurios A
‘ner detstatie impute he olowrg substances woul, preset assent evel ba detected by oreo ln of
‘he tesa n the monograph. They ar ited bythe gooralacsoptance citron ler thedurspected inure andr by
‘ho gener monograph Substanos fo phaemaceteal ue (2034), erefore not cess t ently Ios impuis
for damanstrato of complancs. Seo ao 5.10. Conta af mpuntes substance fo pharmaco se) B,D.
ome
A. tydrogbonzoe ai,
yr wea
. methyl 4ycrybenzoae (ney paranykoxybon2ate)
or
. ty 4yéronsbonzost (thy sarahytonyborzat),
oa
Ho
st ansehen dopey ELSBo 7 8Rbonch ‘ion Paracas Vlan 8
onoarphs: Modal rd Phomacas Sbeanes
Glycerol
‘Sonera Notces
toxin
(Ph. Eur Monograph 0496)
evo
GMOs 92:1 S685
Acton and use
urinate
Preparations
yore Eye Bop
tycert Suppostois
DerNmON
Propane-.2:o
‘content
{83.0 per cont mn to 104.0 por cont min fnystou substance),
‘CHARACTERS.
Aspect: spy ld, unctuous he buch, clots ox almost colores, claw, vary hyrascnia.
Solubitty
‘Mace wth water and wih ethanol (85 perce), igh soluble in acetone, pace ieohible in alta
scents
IDENTIFICATION
rst onion: A,
Second Identication A, 6, D
1A. Refractive index (ee Tests)
B. narod absorption epactoohtamoty (22.20,
Preparation ToS sm. of alr Ron i cael
{Comparison Ph Eu rfroncospecrum of geal (85 pa con)
Cc mL with 0. mL of ntre ae R Suprinpore G5 mi of polassim donate salu R. Ave ng develaps
at to interface of hea. itn Orin, the Bn ccur does not dit in the owor ayer
. Heat mL wih 2 of potaesium ychogon sulle Rin an avaperating deh Vaour acon are evlved wich
blacken tr papermeregnaed with alan possum laliodomercura salon R.
vests
Solution §
pine ghomocpe.cuatpaoisentp andere LGZAnBse7ARnch ™ Dit 10.0 to 200.0 mL with carbon conde sr war
‘Appearance of solution
‘Solution $i clear (221, Dae 101 of olan 625% wih water, Tha sokten is clauoes (22.2, Method
Actety 0 teatnny
‘o.50 mL. of sation S add 0.5 mk ofahorepthaein soliton R. The solution i colousess, Nat more han 02m of 0.5 M
sal yaoi required to change the clr of bs inate pink
Refractive index (22.8
170101475,
Aldohydes
Maxérum 10 pom,
Pace 7.5 mk of stuton Sa groune-lass-stoppered flask and ada 7 mL of water Rand 1.0 mb of dca
‘araoszniia soul R. Coss he fk and aw to sta fr 1 hata tempera of 25 +1. The abaabancn (2.2.26)
‘tthe sluton messed at 652 nm isha grater than that of tana prepered athe sare no a ine same
‘manner asing 75 mol omaetyue tandod sauton (5 pom CH,0} Rane 78m. of waar R he st not etd
nes the standards pik
tors
‘Ad 10.0 mi of 0.1 stn hyo othe ea sola tind in th eto acy ar alkaliny, Ba under a enx
‘andeneorfor Sin. Cac Add 0.5m of phonalthaehncalition an tte wth tM hychochtoic nc. Not ss than
Omit of 01 Mhycrochir acti ered o change the caaur of he nda.
Impurity A andratetod substances
(Gas ehromatogrephy (2.2.20.
Test onion Diu 0.0m of slaton $1 10.0 mt wih water
Feferance solution (3) lute 10.0 got gycora Rt 20.0 mL with wate ite 100m. of slain o 100.0 mL.
wh water
Feferonce solution (8) DissoWa 1000 go tyne hea Rin watr Rand eta la 10,0 mk wth he same salve,
Reference solution (c) Dito 1.0 ofternce aston (lo 1.0m with reference etiton (a) ia 4.0. ot
{hi soon 20.00 mw reference soon (a).
‘Reference soliton () Mi 1.0 mf ha tet slutn and 5.0 mk reference soon fb) and dt to 100 mL wi
‘waar it 1.0m of hi soon 100m wth water,
Reference solution fo). Die 0m of reforonce sokton (00.0 th water
cot:
ze: 1= 0 m, 8 = 0.58 mm,
—stationary pas: 6 percent akeyanopopybhanyshxane and 9 par eon of posnalystoxane,
Carrer gas eum forchomatopty
Splitatlo 10
Linear velocity 98 ems
Temperature
ipa emssopni cat Sbaintp a aediyr-YAZAVL ZAG SHAT? AIO a” Detection Flan ionisation.
Injection 05.
tution order impunty Rayer
System sutabinyReterence sla 8
resolute minum 70 between he peaks duet impunity Aan cera
ii
—Inpunty & not more than he se te carespanding pean tre chromatogram ebisinad with roferonce stan
(01 por con
= any oor impart wth a rotenten tno loss than tho rotation ee of yar nt mare than the ea o the peak
<1 mur Anta cherstogam oisined th elerence eckiten (6) (01 par cot
tot of al impuntios wih tent tins rete than the eenton time of coat nat more than 5 times
the peak de fo pur Ain the eomatograr cainod with ference slain () (5 pe cnt
— tragar tin 0.05 tmos the 8a ofthe peak duo to input Ain the cvomaogram ebtalned wih erence
Salut) (0.05 pr cen
re.
Halogenated compounds
Maximum 35pm,
To 10, of shin $a 1m of secur tox salt 5m of war Rand 60 me of halogen nic
lumina aley R. Heal on awalr-ah fer 10min, aw coo andi. Rinse the ask ae to ar wth tor Rr
25 of fivae's blaine, To mL ote fale 28 4m thane (86 po con) R25 mL ef water, CS ic
‘at and 005m of sve nate soion 2 and ms. Mow oeand for 2 in, Any opaesconce te soon snot
more intense an tat na standard ropare a the sre tie by ming 7. mL of ehorde standard stun 5 ppm Ci)
FRA of thao! (26 por can Om of wale R015 file aes Rand 0.05 mo vr na soliton
sugars
To 10 mb of soliton S od 1 mo elo sure aid Rand hoot on a walarbath Sin Aad 3m eabonattos
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