锛?/p>
1092
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INTRODUCTION
鍓嶈█
Purpose
鐩殑
The Dissolution Procedure: Developmentand Validation
<1092>
provides
a
comprehensive
approach
covering
items
to considerfor developing and validating dissolution
procedures and the accompanyinganalytical procedures. It
addresses the use of automation throughout the testand
provides
guidance
and
criteria
for
validation.
It
also
addresses
thetreatment of the data generated and the interpretation
of
acceptance
criteriafor
immediate-
and
modified-release
solid oral dosage forms.
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:
寮�鍙戝拰楠岃瘉锛?/p>
1092
锛夋寚瀵煎師鍒?/p>
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涓互鍙婇噰鐢ㄧ浉搴斿垎鏋愭柟娉曟椂闇�瑕佽�冭檻鐨勫洜绱犮�?/p>
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杩囩▼锛?/p>
骞跺鏂规硶鎻愪緵浜嗘寚瀵煎拰楠岃瘉鏍囧噯銆?/p>
鍚屾椂瀹冭繕娑夊強瀵规櫘閫氬埗鍓傚拰缂撻噴鍒跺墏鎵�
鐢熸垚鐨勬暟鎹拰鎺ュ彈鏍囧噯杩涜璇存槑銆?/p>
Scope
鑼冨洿
Chapter
<1092>
addresses
the
development
andvalidation
of
dissolution
procedures,
with
a
focus
on
solid
oral
dosage
forms.Many of the concepts presented, however, may be
applicable
to
other
dosageforms
and
routes
of
administration.
General recommendations are given with theunderstanding
that
modifications
of
the
apparatus
and
procedures
as
given
in
USP
general chapters need to be justified.
<1092>
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閲嶇偣鏄彛鏈嶅浐浣撳埗鍓傘�?/p>
鎵�鎻?/p>
鍑虹殑璁稿姒傚康涔熷彲鑳介�傜敤浜庡叾浠栧墏鍨嬪拰缁欒嵂閫斿緞銆?/p>
鍏充簬璁惧鍜屾柟娉曠殑淇敼閮ㄥ垎鍦?/p>
USP
閫氬垯涓粰鍑轰簡鍚堢悊鐨勮鏄庛�?/p>
The
organization
of
<1092>
follows
the
sequence
of
actions
often performed inthe development and validation of a
dissolution
test.
The
sections
appear
inthe
following
sequence.