m6 - Quality Control of Tablet
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Transcript of m6 - Quality Control of Tablet
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QUALITY CONTROL OF
TABLET PROPERTIES
AGNES NUNIEK WINANTARI
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MACAM PENGUJIAN
Pengujian kualitas talet !ang iasa
"ilakukan# !aitu$
% P&a'(a)*+*eial Test ,Res(i-
% N*n.+&a'(a)*+*eial Test ,Ti"ak Res(i-
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P/ARMACOPOEIAL TESTS
01 Uni2*'(it! *2 3eig&t
41 C*ntent *2 a)ti5e ing'e"ient
61 Uni2*'(it! *2 )*ntent71 8isinteg'ati*n
91 8iss*luti*n
:1 F'iailit!
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NON.P/ARMACOPOEIAL TESTS
% 8i(ensi*n
% C'us&ing st'engt&
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Uni2*'(it! *2 3eig&t
% 8ite'a+kan +a"a +'*"uk !g (engan"ung
;at akti2 9< (g atau lei& !g (e'u+akan
9
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Uni2*'(it! *2 3eig&t ,)*nt1-
% Uji +en!i(+angan **t "a+at (enja"i +ili&an
untuk (enentukan kese'aga(an kan"ungan
"ala( talet ila seagian esa' ,>< . >9=-
talet e'isi ;at akti21
% C*nt*&$
?ese'aga(an **t talet Pa'a)eta(*l :9
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Uni2*'(it! *2 C*ntent
% 8ilakukan ila kan"ungan ;at akti2 "ala(
talet ku'ang "a'i 9< (g
% 8ilakukan te'&a"a+ 0< talet% S!a'at$ ti"ak *le& lei& "a'i 4 talet !ang
ka"a'n!a "i lua' 'entang 9.009= "an ti"ak
*le& lei& "a'i "a'i 0 talet !ang ka"a'n!a"ilua' 'entang 9.049=
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8isinteg'ati*n
% 8isinteg'asi $ (engeta&ui 3aktu &an)u'talet
% 8itujukan untuk talet !ang "ie'ikan le3at(ulut# ke)uali talet kun!a& atau taletle+as la(at
% Se"iaan "in!atakan &an)u' se(+u'na# ila
sisa se"iaan !ang te'tinggal +a"a a!akan,kasa- alat uji (e'u+akan (asa lunak !gti"ak (e(+un!ai inti !g jelas
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% Alat$ "isinteg'ati*nteste'
,C*nt*& $ E'3eka-
% Sa(+le $ : talet% Taung "inaikkan
"an "itu'unkan "i
"ala( 3a"a& e'isi)ai'an +a"a 6*C
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8iss*luti*n
% Uji "is*lusi"itujukan untuk(engeta&ui 3aktu+ele+asan a&an
*at "an ka"a'(aksi(u( te')a+ai"l( (e"ia "is*lusi
% Ba&an *at &a'use'a"a "ala(entuk la'utanseelu( as*'+si
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% C*nt*&$
Uji disolusi terhadap tabletParacetamol
Me"ia "is*lusi$ >
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F'iailit!
% Me'u+akan )a'a lain untuk (enguku'
kekuatan talet1
% Menggunakan "ua (a)a( alat# !aitu$Rolling and Impact Durability Tester# untuk
(enentukan "a!a ta&an la(a talet "an
Abrasion Tablet Tester# untuk (enentukan"a!a ta&an g*'es talet1
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F'iailit! ,)*nt1-
% P'insi+$ untuk (enguji ke'a+u&an talet
te'&a"a+ antingan "an gesekan
sela(a 3aktu te'tentu1
% Untuk talet e'**t :9< (g $ 4< talet!ang tela& "iti(ang e'atn!a
"i(asukkan ke "ala( alat uji "an
"i+uta' sa(+ai 0
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F'iailit! Teste'
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8i(ensi*n
% ?ese'aga(an uku'an "igunakan untuk
tujuan estetika1
% 8ilakukan te'&a"a+ 4< talet "an"itentukan uku'an teal "an "ia(ete'
talet1
%S!a'at$ "ia(ete' talet ti"ak *le& 6 kali"an ti"ak *le& @ 0 06 teal talet1
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C'us&ing St'engt& /a'"ness
% Talet &a'us (e(+un!ai kekuatan atau
keke'asan te'tentu aga' "a+at e'ta&an
te'&a"a+ e'agai gun)angan (ekanik +a"a
saat manufacturing pac!aging s"ipping1% Alat !ang "igunakan$ /a'"ness Teste'1
% Ma)a(.(a)a( &a'"ness teste'$ E'3eka#
M*nsant*# P2i;e'# S)&leunige'# St'*ng.C*% P'insi+$ (enguku' tekanan !ang "i+e'lukan
untuk (e(ata&kan talet ,satuan$ kil*g'a(-
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MONSANTO /a'"ness Teste'
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Uji Stailitas
% Real ti(e stu"!
% A))ele'ate" stu"!
Pa'a(ete' !ang "ia(ati
O
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Pele+asan Oat se)a'a In
Hi5*
% Pengujian BABE
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PUSTA?A
% FI III1 0>>1
% FI IH1 4