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42-3.2:2004


2004

42-3.2:2004

.

1
2
3
4
5
5.1 :

5.1.1 5.1
5.1.1.1
5.1.1.2
5.1.1.3
5.1.2
5.1.2.1 ()
5.1.2.2
5.1.2.3
5.1.2.4 ,
5.1.2.5 ,
5.1.2.6
5.1.2.7
5.1.2.8
5.1.2.9
5.1.2.10
5.1.2.11
5.1.3
5.1.3.1 :
5.1.3.2
5.. /
5.2
5.2.1
5.2.1.1 ,
5.2.1.2
5.2.1.3 , ,
,
5.2.1.4 , ,

5.2.1.5
5.2.2
5.2.3

IV
1
1
2
5
5
5
5
5
5
6
6
6
7
7
7
7
8
8
8
8
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9
9
9
10
12
22
22
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39

III

42-3.2:2004
CPMP/ICH/282/95 (Q3B) Note for guidance on impurities in new drag products, 1996
(CPMP/ICH/282/95 (Q3B)
, 1996)
CPMP/ICH/283/95 (Q3C) Note for guidance on impurities: residual solvents, 1997
(CPMP/ICH/283/95 (Q3C) : , 1997)
3
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3.3.2 (rapidly dissolving products, [I])

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42-3.2:2004
4


TIA

MP

Committee for Proprietary Medicinal Products (


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GMP
Good Manufacturing Practice ( )
ICH
International Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (
)
LAL- Limulus amoebocyte lysate test (
Limulus polyphemus)
PDG
Pharmacopoeial Discussion Group ( )
5
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42-3.2:2004
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42-3.2:2004
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42-3.2:2004
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42-3.2:2004
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42-3.2:2004
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42-3.2:2004
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23

42-3.2:2004
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42-3.2:2004
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42-3.2:2004
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26

42-3.2:2004
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42-3.2:2004

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29

42-3.2:2004



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42-3.2:2004

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42-3.2:2004
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42-3.2:2004



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