Soos-+

-6
Cerüificate of Analysis INSTRUCT|Oi¡9 USE: Do not &y, use on t[c as is b¡¡ie. Thc intcrnai pcssurc of
FIOR
tb coilaincr mry differnt ffom fho rtnmphÉric pr.{¡s¡¡s rt the .user'B
be süghtly
lration opcn slowly ond oarelülly to aüoid disperrion of tüe salcri¡I. This o¿teri¿l is
¡s() t?{ti¿ i¡tended for l¿boratory Use only. Not frr drug, household or othar es.
ANAB ('0l1ri {8.1.170
TRACEABILÍTYAS$AY
t§rr,il{ 170¿; argy dirtct iaceability b pharmacnpeial sta¡rda¡ú
At!¡B ( Pfl* Al-141i7
PHENOL Comparaúive deÍ¡onsÚrat€s

CERN HE D REFERET{C E MAT ERIAL IIETHOD: HPLC

CERTIFIED PURTTY: 100.0 9Ó, U* =rO.OeXk =Z

(MasÉ Balancelás is ba¡i¡)
Coh¡mn: Ascdtir Phelyl 4.6 mm x 250m4 5 ¡rm
Ivlobilc Pba¡o: \lr¿ter, Aoctsnitrilc (60:4{t)
NOMINAL PACT(AGE SIZE: tg
FlowR¡te: l.0nUmin
Cohuua Temprrrtruc: 30 "C
CATALOG#: PHRI047 LOT#: LRACI665 Injc*tforo: Z) ¡rL
Dctector: 254 ¡m
CERT|HCATEVER§ON:LRACIéó5.1 |S§UEDATE: lSAprit2tllg
NotG: Cqtilircatcr ñay be u¡datd dw to Pfumopeiol Lat claaga or the awilability af @ .lsra.
Cfuekqt wsbsíte il; wt¡¡w.sigma-aldfich.com lbr tls ilqtw¡É.tt waiofl- from Lot:

Cnil €XPIRATION: 30 April2023 (Prapcr §tongc ond Handling Requircd¡.

RECBPTOATE:
Note: this sprce is pmvi&d forconvenience orúy ald its rxc is not rcguired.

STORAGE: §torc in a *,efiigerstor/Protect from Air and Ligl¡t, kecp conrai¡cr tightty
closed, Attachrnent of ¿ 20 mm ¡luminum crimp seal reco¡ir¡r¡enffi for unrsed portims.

CHEUICALFORMULA: C6tl6O ttly:94.11

PHYSICAL DESC$PIION: Cryrrrllioe rues in amber vi¿l CAS *, lOg-CS-:

HAZAR9S: Read §afaiy Data Sheet before usi¡rg. All ctemical rtference mrterials ASSAY BY TITRATION
should bc considered polentíally hazardous ad should be used only by qualified Metkxl: Rssidml titmtion 0.lN Bromim and 0.1 N sodium Tiiosulfate (ref Currcnt
laboratory perronnel. Compendial Monographs)

Mean of ni¡e meosu¡Éments: 99.6'/o

sÉ,MA-ALgprc,{'
Page I of6 Puge 2 of6
sIÉMA-ALTfFffiI
PURITY DETERMINATION BY MASS BALANCE RE§IDUEANALYSI'
Mctüod: Evaporation (ref.: Cunent Compe¡dial Monographs)
C}IROMATOGRAPHIC IMPURITY ANALYSIS Sample Sizc: ^ 85 mg
Mean ofth¡ee ncasurements, Reeidue = Noar
MEiHOD: GC
Column: §rpelco Equity l, lsm x 0.53mm x t.S¡rni
Canicr Gar: I{2
Flo*:4.5 ml-/ñ¡n CEfrTIFIFD PURIIY BY fdASS BALANCE [loo%- tmpurities (normatizcd)]
Terriperature Progrrm: 4fC for 6 min, l5qc/min to 140"C, hold 5 min
I4fuctiou: lpl" ?00qC 100.0 o/o U*: *0.0696. k * 2
SplitRatio: l0;l (as is basie)
DetEútori FlD,20(FC

Implritics Detcctcd:
Nodr Dctccfed tqENnHcAnoNTESTS

INFRARED SPECTROPHOTOMETRY (Cornpamtíve irkntifi cation anatysis

deÍxlnstratcs dkrct tracs¿bility to Phr¡mácopeial standards)

§"4

USP
RESEUALSOLVENTS
Method: GC-M§ Headepace (ref'.: Adapted fmm Résidu¡l Soh'eots U§P ?47>l
Coltrññ: sPB{24 T
Carricr gas; [Ie
Flo*: l.2mUmin
Split Ratio: I 15 3500 tJ00
oC e-l
InjeotionlTempemturc: I mU220
Tenlperature Progr¿m: 40 "C for 5 min, I 'C/min to 2(x) "C, hoH 5 min ** Pt rol s.A Lo{ LRAC l6d3 E3¡§-E1¡Er§rEf,:*r.r¡¡le
Ptad UgP L¡IROóIS0 §¡.!Ol¡lic: m:Íl$rÁn
Solvc¡8 Detectcd: No¡c

IYATER DETERUINATIOU
Mctlrcd: Karl Fisher títration (ref.: Cunent Compendial Monographs)
Mo¿n of thrpe nrasurement8, Watcr Contcnt Note :

Page 3 of6 Page 4 of6

ác/Ma-4¡fJti/g¡a SGMA..ALEIFIE'.I
 MASS sPECTRUM
Mcthod: HR-QTOF;4.0 kV
STABILITY ASSESSMENT
Significmcc of the §tab¡lity asscscment will b€ d€msrstrarcd if thc aoal¡ical ¡csult of tts
ESI-; tcmp€ruturc:325 0C study anC the range of valuer repreeentgd by ttre Expan&d Uncertains do not frcrlap thc
rciult of lbe origimt rsray and the rurgc of íts valms rcprceeotcd by thc Expandcd
Unccrt itrty. Thc mrthod cmployed will usrully bc thc s¡ma ¡¡cthod ursd to chtroct rizo
the assay valrr in the inítial evatuation.
I"ong Tenn §tability Evahution - Al assc§s¡ne¡t, or ¡Etcst, vcñ¡¡s a Comp€trdial
Rcforcqr §t¡¡d¡rd may bc schcduled, witiin the 3 ycrr aanivcrur! dats of¡ rrlaa¡c ofa
Secondary §tundud. The re-test inErv¡l ¡¡ill be detcrmirrcd on a care-by+rs€ basi¡.
Shorf Tcrm Stability Study - lt ic uscfi¡l to assces staúili¡y rmdcr rcasonrbly rnticipafd
short l€rE traú¡sportcooditio¡¡ by eimularilg exposurc of6e product to bumidity ond
tcmpe¡ature stress- ttr;s tpe of rtudy is conó¡ctcd E der co¡rt¡otled cor¡ditiom of
clcvaed temperrture a¡rd hunidry.

Thcorctical valuc: 93.03411 tn/z

Thc signal ofthe MS spec8um is corsistent with tt¡c theoretical vah¡c and its
inGrgctation is coasi¡tent with tbc shuctu¡al tb¡mul¿.
fu6*- -h.l,^f?, l¿¡
QCManapr Head Quality AssurEncc

HOI.IOGENEITY A§SES§MENT
Hoürgcncity wirs ¡s¡csrcd i¡ rcord¡acc ryith ISIO G¡ide 35. CoopbEd uaits wcrc
rampled uring a rmdom *rüified sanpling protocril. Ttre remlt of chenical analyrir
wctc tbcn co,ryrrcd by SiDglc Frror Amtyris of Vadam (ANOVA). Thc r¡nccrtaintf.
drr to hmogcncity was dcrivcd ftim tho ANOVA, H¡t fi¡gctrGity u/a Dt dcEctcd APPENDTX
u¡der t rc conditio¡rc of lh., ANOVA.
Originrl khr¡c DeE: l8 April 2019
Analytic¡l Mcthod: IIPLC Srnrple ízc: - 50 mg

I.NCERTAINTY STATE MENT

Uacertaiu§ values i¡ this doouttrcot rc exprcsred as Expaodcd Unccrt¡inty OJ
c-oncspodiog to thc 95olo co¡fidcncc intcrval. U* is derived riüm thc combincd
st¡nd¡nd unccrtar-nty mutt¡pl¡cd by the covcBgr ftctor k, which is obtained fmm e l-
Ale«,r +ac ¡g.to
dishibutim and dcgrecs of &rocdom. Thc conpomr[s of cúmbbed standrd unccrtaio§
hclüde ttc rrc€rrainrie¡ duc to ch¡r¡ctoizatioa, homogcncity, foag torm etability, and *i,flf.Ii,',Í;i.".
------.*'n
short terÍr st¡bilíty (trarsfrt). Ttr co¡rpo¡rcnb eE to shbility are genenlly considcred i
to be negligiblc unless otbswisc indicatod by rtability studies.

SftrMA-ALrFI/CH
Page 5 of6
Hanuf¿ctnd ed certñed by Slgnr}A¡e1dt RTq IrE.
Z93f SoH€r Sprhou Rd, taralñtc WY, lr§{ S2O7!
(Ptrté)t r-fi7-712-152 G¿r): t-05H3t{2r2
erull: RTcleclúor¡€dd.om
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