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BRIEF INTRODUCTION TO SCHEDULE Y

Schedule Y !e "he !e$u%!e&e'"( 'd )u%del%'e( *+! ,e!&%((%+' "+ %&,+!"'d +! &'u*c"u!e +* 'e. d!u)( *+! (le +! "+ u'de!"/e cl%'%cl"!%l( %' I'd%

APEDICES DER SCHEDE- Y4

The!e !e 11 A,,e'd%ce( (,ec%ed u'de! Schedule Y4

I 4 D" !e$u%!ed *+! %&,+!"&'u*c"u!e "+ c+'duc" cl%'%cl "!%l + *'e. d!u)

IA 4 F+! ,,!+6l +* d!u)( %' I'd% .h%ch !e l!ed ,,!+6ed %' +"he!c+u'"!%e(

II 4 F+!&"( *+! cl%'%cl ("ud !e,+!"( 9ICH E:; III 4 A'%&l "+

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=I4 F%%'"%+'( 9FDC?(; =II4 'de!"/%') > I'6e("%)"+! =III4 E"h%c( C+&&%""ee I@4 S">%l%" Te("%') +* D!u) @4 P!+,+(ed P!+"+c+l @I4 Se!%+u( Ad6e!(e Eec"( Re,+!"%')

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APPENDIX IX

(STABILITY TESTING OF NEW DRUGS)

S">%l%" "e("%') %( "+ >e ,e!*+!&ed "+ ,!+6%dee6%de'ce +' h+. "he $ul%" +* d!u) (u>("'ce+! *+!&ul"%+' 6!%e( .%"h "%&e u'de! "he%'Bue'ce +* 6!%+u( e'6%!+'&e'"l *c"+!( (uch

( "e&,e!"u!e hu&%d%" 'd l%)h" 'd "+e(">l%(h (hel* l%*e *+! "he *+!&ul"%+' 'd!ec+&&e'ded ("+!)e c+'d%"%+'(

S">%l%" ("ud%e( (h+uld %'clude "e("%') +* "h+(e""!%>u"e( +* "he d!u) (u>("'ce "h" !e(u(ce,"%>le "+ ch')e du!%') ("+!)e 'd !el%/el "+ %'Bue'ce $ul%" (*e" 'd +! ecc

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F+! F+!&ul"%+'( "he "e("%') (h+uld c+6e! (,,!+,!%"e "he ,h(%cl che&%cl >%+l+)%cl 'd&%c!+>%+l+)%cl ""!%>u"e( ,!e(e!6"%6e c+'"e'"

9e) '"%+ec+'duc"ed "+ %de'"%* "he l%/el de)!d"%+',!+duc"( .h%ch %' "u!' e(">l%(h "he de)!d"%+',"h.( e6lu"e "he %'"!%'(%c (">%l%" +* "he&+lecule 'd 6l%d"e "he (">%l%" %'d%c"%') ,+.e!

+* "he 'l"%cl ,!+cedu!e( u(ed The '"u!e +* "he("!e(( "e("%') .%ll de,e'd +' "he %'d%6%dul d!u)(u>("'ce 'd "he ",e +* *+!&ul"%+' %'6+l6ed

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S"!e(( "e("%') & )e'e!ll >e c!!%ed +u" +' (%')le >"ch +* "he d!u) (u>("'ce I" (h+uld%'clude "he eec" +* "e&,e!"u!e9(; hu&%d%".he!e ,,!+,!%"e +

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F+! l+') "e!& ("ud%e( *!e$ue'c +* "e("%') (h+uld >e(uc%e'" "+ e(">l%(h "he (">%l%" ,!+le +* "he d!u)(u>("'ce I' )e'e!l d!u) (u>("'ce (h+uld >e

e6lu"ed u'de! ("+!)e c+'d%"%+'( "h" "e(" %"("he!&l (">%l%" 'd %* ,,l%c>le %"( (e'(%"%6%" "+&+%("u!e The ("+!)e c+'d%"%+'( 'd "he le')"h +*"he ("ud%e( ch+(e' (h+uld >e (uc%e'" "+ c+6e!("+!)e (h%,&e'" 'd (u>(e$ue'" u(e

PILOT SCALE BATCHING

P%l+" (cle %( >"ch +* d!u) (u>("'ce +! d!u),!+duc" &'u*c"u!ed > ,!+cedu!e *ull!e,!e(e'""%6e +* 'd (%&ul"%') "h" "+ >e ,,l%ed

"+ *ull ,!+duc"%+' (cle >"ch F+! (+l%d +!l d+()e*+!&( ,%l+" (cle %( )e'e!ll " &%'%&u& +'e-"e'"h "h" +* *ull ,!+duc"%+' (cle +! 100000">le"( +! c,(ule( .h%che6e! %( "he l!)e!

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I' c(e +* d!u) (u>("'ce( "he >"che( (h+uld>e &'u*c"u!ed "+ &%'%&u& +* ,%l+" (cle >"he (&e ('"he"%c !+u"e 'd u(%') &e"h+d +*

&'u*c"u!e "h" (%&ul"e( "he 'l ,!+ce(( "+>e u(ed *+! ,!+duc"%+' >"che( I' c(e +**+!&ul"%+'( ".+ +* "he "h!ee >"che( (h+uld >e" le(" ,%l+" (cle 'd "he "h%!d +'e & >e

(&lle! The &'u*c"u!%') ,!+ce((9e(; u(ed *+! ,!%&!

>"che( (h+uld (%&ul"e "h" "+ >e ,,l%ed "+,!+duc"%+' >"che( 'd (h+uld ,!+6%de ,!+duc"(

+* "he (&e $ul%" 'd &ee"%') "he (&e(,ec%c"%+'( ( "h" %'"e'ded *+! &!/e"%')

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TESTING CONDITIONS

The (">%l%" ("ud%e( *+! d!u) (u>("'ce( (h+uld>e c+'duc"ed e%"he! %' "he (&e c+'"%'e! -cl+(u!e (("e& ( ,!+,+(ed *+! ("+!)e 'dd%("!%>u"%+' +! %' c+'"%'e! - cl+(u!e (("e&"h" (%&ul"e( "he ,!+,+(ed 'l ,c/)%') I'

c(e +* *+!&ul"%+'( "he (">%l%" ("ud%e( (h+uld>e c+'duc"ed %' "he 'l c+'"%'e! - cl+(u!e(("e& ,!+,+(ed *+! &!/e"%')

S"ud c+'d%"%+'( *+! d!u) (u>("'ce( 'd

*+!&ul"%+'( %'"e'ded "+ >e ("+!ed u'de!)e'e!l c+'d%"%+'(

STUDY STUDYCONDIITIONS

DURATION OF STUDY

+') Te!& 30C 2C :5RH 5RH

12 M+'"h(

Accele!"ed 0C 2C 75

RH 5 RH

: M+'"h(

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I* " ' "%&e du!%') : &+'"h( "e("%') u'de!"he ccele!"ed ("+!)e c+'d%"%+' (uch ch')e(

+ccu! "h" cu(e "he ,!+duc" "+ *%l %' c+&,l%').%"h "he ,!e(c!%>ed ("'d!d( dd%"%+'l "e("%')u'de! ' %'"e!&ed%"e ("+!)e c+'d%"%+' (h+uld>e c+'duc"ed 'd e6lu"ed )%'(" (%)'%c'"

ch')e c!%"e!%

S"ud c+'d%"%+'( *+! d!u) (u>("'ce( 'd*+!&ul"%+'( %'"e'ded "+ >e ("+!ed %' !e*!%)e!"+!

STUDY STUDY

CONDITIONS

DURATION OF

STUDY+') Te!& 5C 3C 12 M+'"h(

Accele!"ed 25C 2C :0RH 5 RH

: M+'"h(

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S"ud c+'d%"%+'( *+! d!u) (u>("'ce( 'd*+!&ul"%+'( %'"e'ded "+ >e ("+!ed %' *!eee!

D!u) (u>("'ce( %'"e'ded *+! ("+!)e >el+.

-20C (hll >e "!e"ed +' c(e ->-c(e S">%l%" "e("%') +* "he *+!&ul"%+' *"e!

c+'("%"u"%+' +! d%lu"%+' %* ,,l%c>le (h+uld >ec+'duc"ed "+ ,!+6%de %'*+!&"%+' *+! "hel>ell%') +' "he ,!e,!"%+' ("+!)e c+'d%"%+''d %'-u(e ,e!%+d +* "he c+'("%"u"ed +! d%lu"ed,!+duc" Th%( "e("%') (h+uld >e ,e!*+!&ed +' "hec+'("%"u"ed +! d%lu"ed ,!+duc" "h!+u)h "he,!+,+(ed %'-u(e ,e!%+d

STUDY STUDY

CONDITIONS

DURATION OF

STUDY

+') Te!& -20C 5C 12 M+'"h(

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REFERENCES

1 Ge""e +* I'd% 9e