Document Text Contents
Page 1
Name: Mas, Mylyn L. Date Submitted: 10/28/16
Pharm Chem 1! Se"ti#n: P$6 Date Per%#rmed: 11/0!/16
&'(eriment N#. !
C#m(le'#metry
Assay o Assay of Alumf Alumina and Magina and Magnesia Onesia Oral Susperal Suspension for nsion for AluminuAluminum Content m Content
). D*+* *ND &S-L+S
*. #lume/eihin Measurements
Sam(le 1: *lumina and Manesia ral Sus(ensi#n
#lume #% Sam(le St#"3 S#luti#n4:
+rial 14 : 2!0.0 mL +rial 24 : 2!0.0 mL
*li5u#t: +rial 14 : 10.0 mL +rial 24 : 10.0 mL lan34: 10.0 mL 7ater4
. +itrati#n Data
#lume #% +itrant -sed:
VVoolluumme e RReeaaddiinngg TTrriiaal l 11 TTrriiaal l 22 BBllaannk k ((nn//a a bbaasseed d oonn
USP)USP)
Initial ReadingInitial Reading 0.00 mL 0.00 mL 2!.0! mL
Final ReadingFinal Reading 2!.0! mL 2!.0! mL !0.10 mL
Total Volume UsedTotal Volume Used 2!.0! mL 2!.0! mL 2.0! mL
#lumetri" S#luti#n -sed: Dis#dium &detate
N%9 0.61;
Pre(ared by: il#ria, L#<ely Mae .
#lume #% a"3 +itrant -sed:
VVoolluumme e RReeaaddiinngg TTrriiaal l 11 TTrriiaal l 22 BBllaannk k ((nn//a a bbaasseed d oonn
USP)USP)
Initial ReadingInitial Reading 0.00 mL 0.00 mL 1.! mL
Final ReadingFinal Reading 1.60 mL 1.! mL .;! mL
Page 2
Total Volume UsedTotal Volume Used 1.60 mL 1.! mL 0 .0 mL
#lumetri" S#luti#n -sed: 0.0! M =in" Sul%ate
N%9 0.!8
Pre(ared by: Cle# aliente
Calulated ! o" #ti$e Ingredient%Calulated ! o" #ti$e Ingredient%
&abelled Claim% 22' mg/' m&&abelled Claim% 22' mg/' m&
Trial 1Trial 1: 10. > #% *l$4 in Sam(le Trial 2Trial 2: 10!.8; > #% #% *l$4 in Sam(le
> De<iati#n et7een +rials: 0.881 >
*""e(tan"e "riteria: 0.0 >?110.0>4
Sam(le: P#SS T* +FFICI#& R,UIR-.TP#SS T* +FFICI#& R,UIR-.T
)). D)SC-SS)N
* sus(ensi#n #% *lumina and Manesia ral Sus(ensi#n Labelled Claim: 22! m/!mL4
7as assayed. Sam(le is "#m(#sed #% 7hite sus(ended (arti"les that needs t# be sha3en 7ell
be%#re use. )t 7as st#red in a 7hite (lasti" "#ntainer that 7as tihtly "l#sed. +he sam(le 7as n#t
%reshly (re(ared and 7as #(ened durin the 7ee3 #% the assay "t#ber 2?28, 20164.
+7# titrati#n trials 7ere (er%#rmed %#r the assay #% *luminum $ydr#'ide "#ntent #%
*lumina and Manesia ral Sus(ensi#n 7ith Dis#dium &detate S as the e'"ess titrant and
0.0! M =in" Sul%ate S as the ba"3 titrant. * 0.881 > de<iati#n bet7een b#th trials 7as
a"5uired. +he > de<iati#n <alue %alls 7ithin the @ > de<iati#n rane, indi"atin that the results
#btained are #% hih (re"isi#n. )n additi#n, a 10. > and 10!.8;> a"ti<e inredient %#r +rial
1 and +rial 2, res(e"ti<ely 7ere "al"ulated . +he > a"ti<e inredient #% the sam(le met the
a""e(tan"e "riteria set %#r *luminum $ydr#'ide "#ntent #% *lumina and Manesia ral
Sus(ensi#n 0.0?110.0 >4 7hi"h means that the sam(le is #% ##d 5uality.
* m#di%i"ati#n #% the #riinal (r#"edure d#ne is the am#unt #% dithiA#ne t# be added #n
the sam(le. +he (r#"edure indi"ates additi#n #% 2 mL #% dithiA#ne, h#7e<er, sin"e at this <#lume
n# "#l#r is e<ident sam(le is still "#l#rless4 a 6 mL <#lume #% dithiA#ne 7as used. *t 6 mL, the
reen?<i#let "#l#r be"ame e<ident. +his additi#n #% <#lume has n# sini%i"ant e%%e"t #n the assay
sin"e the %#rmati#n #% the Ain" dithiA#nate "#m(le' is #nly de(endent i% there are already %ree,
e'"ess Ain" #n the rea"ti#n mi'ture and n#t #n the am#unt #% dithiA#ne (resent. )n additi#n, the
Name: Mas, Mylyn L. Date Submitted: 10/28/16
Pharm Chem 1! Se"ti#n: P$6 Date Per%#rmed: 11/0!/16
&'(eriment N#. !
C#m(le'#metry
Assay o Assay of Alumf Alumina and Magina and Magnesia Onesia Oral Susperal Suspension for nsion for AluminuAluminum Content m Content
). D*+* *ND &S-L+S
*. #lume/eihin Measurements
Sam(le 1: *lumina and Manesia ral Sus(ensi#n
#lume #% Sam(le St#"3 S#luti#n4:
+rial 14 : 2!0.0 mL +rial 24 : 2!0.0 mL
*li5u#t: +rial 14 : 10.0 mL +rial 24 : 10.0 mL lan34: 10.0 mL 7ater4
. +itrati#n Data
#lume #% +itrant -sed:
VVoolluumme e RReeaaddiinngg TTrriiaal l 11 TTrriiaal l 22 BBllaannk k ((nn//a a bbaasseed d oonn
USP)USP)
Initial ReadingInitial Reading 0.00 mL 0.00 mL 2!.0! mL
Final ReadingFinal Reading 2!.0! mL 2!.0! mL !0.10 mL
Total Volume UsedTotal Volume Used 2!.0! mL 2!.0! mL 2.0! mL
#lumetri" S#luti#n -sed: Dis#dium &detate
N%9 0.61;
Pre(ared by: il#ria, L#<ely Mae .
#lume #% a"3 +itrant -sed:
VVoolluumme e RReeaaddiinngg TTrriiaal l 11 TTrriiaal l 22 BBllaannk k ((nn//a a bbaasseed d oonn
USP)USP)
Initial ReadingInitial Reading 0.00 mL 0.00 mL 1.! mL
Final ReadingFinal Reading 1.60 mL 1.! mL .;! mL
Page 2
Total Volume UsedTotal Volume Used 1.60 mL 1.! mL 0 .0 mL
#lumetri" S#luti#n -sed: 0.0! M =in" Sul%ate
N%9 0.!8
Pre(ared by: Cle# aliente
Calulated ! o" #ti$e Ingredient%Calulated ! o" #ti$e Ingredient%
&abelled Claim% 22' mg/' m&&abelled Claim% 22' mg/' m&
Trial 1Trial 1: 10. > #% *l$4 in Sam(le Trial 2Trial 2: 10!.8; > #% #% *l$4 in Sam(le
> De<iati#n et7een +rials: 0.881 >
*""e(tan"e "riteria: 0.0 >?110.0>4
Sam(le: P#SS T* +FFICI#& R,UIR-.TP#SS T* +FFICI#& R,UIR-.T
)). D)SC-SS)N
* sus(ensi#n #% *lumina and Manesia ral Sus(ensi#n Labelled Claim: 22! m/!mL4
7as assayed. Sam(le is "#m(#sed #% 7hite sus(ended (arti"les that needs t# be sha3en 7ell
be%#re use. )t 7as st#red in a 7hite (lasti" "#ntainer that 7as tihtly "l#sed. +he sam(le 7as n#t
%reshly (re(ared and 7as #(ened durin the 7ee3 #% the assay "t#ber 2?28, 20164.
+7# titrati#n trials 7ere (er%#rmed %#r the assay #% *luminum $ydr#'ide "#ntent #%
*lumina and Manesia ral Sus(ensi#n 7ith Dis#dium &detate S as the e'"ess titrant and
0.0! M =in" Sul%ate S as the ba"3 titrant. * 0.881 > de<iati#n bet7een b#th trials 7as
a"5uired. +he > de<iati#n <alue %alls 7ithin the @ > de<iati#n rane, indi"atin that the results
#btained are #% hih (re"isi#n. )n additi#n, a 10. > and 10!.8;> a"ti<e inredient %#r +rial
1 and +rial 2, res(e"ti<ely 7ere "al"ulated . +he > a"ti<e inredient #% the sam(le met the
a""e(tan"e "riteria set %#r *luminum $ydr#'ide "#ntent #% *lumina and Manesia ral
Sus(ensi#n 0.0?110.0 >4 7hi"h means that the sam(le is #% ##d 5uality.
* m#di%i"ati#n #% the #riinal (r#"edure d#ne is the am#unt #% dithiA#ne t# be added #n
the sam(le. +he (r#"edure indi"ates additi#n #% 2 mL #% dithiA#ne, h#7e<er, sin"e at this <#lume
n# "#l#r is e<ident sam(le is still "#l#rless4 a 6 mL <#lume #% dithiA#ne 7as used. *t 6 mL, the
reen?<i#let "#l#r be"ame e<ident. +his additi#n #% <#lume has n# sini%i"ant e%%e"t #n the assay
sin"e the %#rmati#n #% the Ain" dithiA#nate "#m(le' is #nly de(endent i% there are already %ree,
e'"ess Ain" #n the rea"ti#n mi'ture and n#t #n the am#unt #% dithiA#ne (resent. )n additi#n, the
