STABILITAS BULAN SEPTEMBER 2012

TANGGAL MASUK

No

Abjad
A

: 25 SEPTEMBER 2012

Nama

Suhu
40oC

Bets

Alpara Syrup
Alphamol Syrup
Alphamol 600 kaplet
Acidblock 150 tablet
Bevalex cream
Bevalex cream

Suhu
30oC

TM 010
TG 015
TM 012
TM 001
TN 049
TD 056

IPC

QC

2 tb

IPC

30
30

Waktu

QC
120 ml
120 ml
20
30
2 tb
2 tb

Keterangan

Ambil Sampel
tgl 25/9/12

18 bln
12 bln
18 bln
18 bln
9 bln
6 bln

Pembagian Sampel
IPC
QC
tgl 25/9/12 tgl 25/9/12

Tanggal Penerimaan Laporan

15/10/12
9/11/2012
2/11/2012
15/10/12

Kesimpulan

diluluskan

Ciprolex kapsul

Trial

20

30

10/12/2012

Diluluskan

Dexmolex 100 mL Syr

Dextral Kaplet
Dextral Forte Kapsul

TD 019
TM 065
TG 047

30
30

120 ml
10
10

90 bln
18 bln
12 bln

msg2 btl 100 mL

8/10/2012
15/10/12
30/10/2012

Diluluskan

Fexazol krim
Fluza Kaplet

TM 001
Trial

24

16

24

2 tb
16

18 bln
3 bln

msg2 tb 5 g

15/10/12

Gentalex cream
Gentalex cream

TO 006
UJ 001

5g

5g
5g

9 bln
6 bln

9/11/2012
12/11/2012

Klorfesson Cream

TM 010

8g

18 bln

Lexapram Syr 60 mL
Lexavit Kaplet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexcomet 16 mg Tablet
Lexaprofen 400 mg Kaplet
Lexagin Kaplet

TN 042
TM 003
TM 007
UA 027
Form 1
Form 2
Form 3
Form 4
Form 5
Form 6
TO 003
TO 008
UM 001

40
40
40
30
40
40

40

20
40
40
40
20
40
40

10

30
50

40
30

120 mL
10
50

36
30

9 bln
18 bln
18 bln
3 bln
1 bln
1 bln
1 bln
1 bln
1 bln
1 bln
9 bln
9 bln
3 bln

Molason Cream
Molavir Cream
Moladerm Cream
Molexdine Sol. 60 mL
Molexdine Sol. 60 mL
Molapect 15 mg 60 mL
Molexflu Syrup
Molexflu Syrup
Molacort 0.75 Tablet
Molaneuron Tablet
Molacort 0.5 Tablet
Molaflam Tablet
Molasic Tablet

UA 006
UA 001
UA 010
TM 006
TM 011
TN 030
TN 020
TN 021
TM 019
TS 009
TN 015
TN 002
UA 006

30
30

7g
6g
10 g

30
30

50
30
50

60 mL
60 mL
120 mL
120 mL
120 mL
50
12
44

3 bln
3 bln
3 bln
18 bln
9 bln
9 bln
9 bln
9 bln
18 bln
9 bln
9 bln
3 bln
3bln

Neo Kaominal Suspensi

TM 011

120 mL

18 mL

22/10/2012

Pritanol 100

UY 012

40

30

3 bln

22/10/2012

Vical Suspensi 60 mL

TN 022

120 mL

9 bln

15/10/12

lexacorton
bevalex

TL 005

40
TS 038

30

9 bln
9 bln

msg2 tb 10 g

disolusi saja

msg2 tb 5 g
msg2 tb 10 g
msg2 btl 60 mL
msg2 btl 60 mL
msg2 btl 60 mL
msg2 btl 60 mL
msg2 btl 60 mL

15/10/12
15/10/12
8/10/2012
8/10/2012
8/11/2012
8/10/2012
8/11/2012
8/10/2012
8/11/2012
8/11/2012

Dilluluskan
Diluluskan

ditolak
Ditolak
Diluluskan
Diluluskan
Diluluskan

15/10/12
15/10/12

22/10/2012
15/10/12
15/10/12
15/10/12
5/11/2012
5/11/2012
3/12/2012
2/11/2012
2/11/2012
28/10/12

Diluluskan

Diluluskan

STABILITAS BULAN OKTOBER 2012

TANGGAL MASUK

No Abjad

Nama

: 25 OKTOBER 2012
Suhu
40oC

Bets

Suhu
30oC

TS 008

IPC

QC

IPC
36

Waktu
QC
24

12 bln

Keterangan

Pembagian Sampel
IPC
QC
tgl 25/10/12
tgl 25/10/12

Tanggal Penerimaan Laporan

IPC

QC

Dicloflam 25 tablet

Gentalex cream

TS 005

5g

12 bln

9/11/2012

Infatrim suspensi
Infatrim forte kaplet
Infatrim Forte Kaplet

TG 032
TN 023
TN 024

40
40

50 ml
20
20

12 bln
9 bln
9 bln

8/11/2012
7/11/2012

8/11/2012
14/11/2012
19/11/2012

Klorfeson Cr. 10 g
Klorfeson Cr. 10 g

TS 035
TS 036

8g
8g

12 bln
12 bln

19/11/2012
19/11/2012

Lexapram Syrup
Lexapram Tablet
Lexacrol Tablet
Lexacrol Tablet
Lexacrol Tablet
Lexacholes Tablet
Lexamet Tablet
Lexamet Tablet
Lexicam 10 Kapsul
Lexicam 10 Kapsul
Lexicam 20 Kapsul
Lexahist 1000
Lexahist 1000
Lexahist
Lexahist
Lexahist
Lexahist
Lexahist
Lexahist

US 036
TG 009
TU 055
TU 056
TD 061
SA 001
UA 006
UA 007
FORM 1
FORM 2
FORM 1
TU 012
TL 013
FROM 1
FROM 2
FROM 3
FROM 4
FROM 5
FROM 6

40
40
40
30
40
40

120 ml

40
40
40
20
40
40

30
40
40
40
30

1 bln
12 bln
12 bln
12 bln
9 bln
18 bln
3 bln
3 bln
9 bln
9 bln
9 bln
12 bln
12 bln
2 bln
2 bln
2 bln
2 bln
2 bln
2 bln

8/11/2012
9/11/2012
9/11/2012
30/10/2012
6/11/2012

5/11/2012

30/10/2012

20
20
20
46
46

30
10
10
10
10
1 stp
2 stp
10
10
10
60
60

6/11/2012
7/11/2012
6/11/2012
7/11/2012
7/11/2012
7/11/2012
8/11/2012
8/11/2012
8/11/2012

5/11/2012
5/11/2012
5/11/2012
7/11/2012
7/11/2012
7/11/2012
6/11/2012
6/11/2012
6/11/2012
7/11/2012
7/11/2012
30/10/2012
30/10/2012
30/10/2012
31/10/2012
31/10/2012
7/11/2012

Molexflu kaplet
Molakrim
Molexdine Sol. 15 mL

TF 004
TL 082
TG 011

46

34
2 tb
3 btl

18 bln
12 bln
12 bln

9/11/2012

16/11/2012
30/10/2012
30/10/2012

Pritagesic Kaplet

TG 011

30

34

12 bln

11/11/2012

7/11/2012

Thiamfilex DS
Thiamfilex DS

TL 018
TL 019

120 ml
120 ml

12 bln
12 bln

30/10/2012
30/10/2012

Vitalex Kapsul

UU 004

30

10

3 bln

30/11/2012

7/11/2012

kurang 24 utk QC

Ambil Sampel
tgl 25/10/12

masing2 tb 10 g

kurang 4 utk QC
uji disolusi saja
uji disolusi saja

cm ambil 1 tb
msg2 botol 15 mL

utk pemerian n kadar

30/11/2012

Kesimpulan Hasil
IPC

QC

Dilluluskan
Diluluskan

diluluskan, ada kebocoran

Diluluskan

Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan

Diluluskan
Diluluskan
diluluskan
Diluluskan
Diluluskan

Diluluskan, ada kebocoran

Diluluskan, ada kebocoran
Diluluskan
Diluluskan
Ditolak
Diluluskan
Ditolak
Ditolak
Ditolak
Ditolak

Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
diluluskan
ditolak
ditolak
diluluskan
diluluskan
Diluluskan
diluluskan

Ditolak

Diluluskan
Diluluskan
Diluluskan

Diluluskan

Diluluskan
Diluluskan
Diluluskan

Diluluskan, ada kebocoran

diluluskan

STABILITAS BULAN NOVEMBER 2012

TANGGAL MASUK

No

Abjad
A

Nama
Acidblok 300
Acidblok 300
Acidblok 300
Antasida DOEN

: 25 NOVEMBER 2012

Bets
Form 1
Form 2
Form 3
30/11/09

Suhu
40oC
IPC QC
26
24
26
24
26
24

Suhu
30oC
IPC QC

antara&ruahan, kadar > sp

antara&ruahan, kadar > sp
13

10

Bevalex Cr
Bevalex Cr
Bevalex Cr

TS 038
TS 039
TS 040

2 tb
2 tb
2 tb

Dexmolex 100 mL
Dextral 60 mL
Dextral 100 mL
Dextral Kaplet
Dextral Kaplet
Dicloflam 25
Dicloflam 25
Dicloflam 50

TO 018
TS 029
TS 008
TS 127
TS 126
TS 008
TS 009
TS 011

30
30
36
36
30

120 mL
120 mL
120 mL
10
10
30
30
30

Fexazol krim
Fexazol Tablet

TO 003
TO 002

42

2 tb
30

Infatrim suspensi

UO 038

Klorfeson krim

TS 037

8 gr

Lexacorton 5 Krim
Lexacorton 5 Krim
Lexacorton 5 Krim
Lexapram Syr 60 mL
Lexaprofen suspensi
Lexavon Syr
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet
Lexahist Tablet

TL 005
TL 006
TG 007
US 036
TO 005
TN 008
Form 1
Form 2
Form 3
Form 4
Form 5
Form 6
PN 002
PN 003
TO 015

7 gr
7 gr
7 gr

50 mL

120 mL
120 mL
120 mL
40
40
40
20
40
40

Waktu

40
40
40
30
40
40
24
34
50

25
40
50

Lexavit Kaplet
Lexavon Tablet

TL 005
TS 005

Molakrim
Mofulex Krim
Molason
Molexdine Sol. 60 mL
Molapect 15 mg 60 mL
Molacort 0.75 Tablet
Molagit Tablet
Molaneuron tablet
Molasma tablet
Methyl Prednisolon

Trial
TS 002
TD 025
TS 011
TS 023
TS 056
TO 027
TS 007
TO 001
TN 001

Phebylbutazone 150
Pritacort Tablet
Pritalinc Kapsul
Pritasma Tablet
Pritanol 300
Pritamox 500 Kapsul

101109
TO 016
TY 002
TS 005
UA 001
UY 007

30
50

10
50

40
46
20
50
40

5 gr
7 gr
60 ml
120 ml
60
10
10
50
34

20
44
26
50
40

10
10
50
30

2 tb

40

Keterangan

Ambil Sampel
tgl 20/11/12

antara & ruahan

antara&ruahan, kadar > spek
antara&ruahan, kadar > spek

Pembagian Sampel
IPC
QC
tgl 21/11/12 tgl 20/11/12

Tanggal Penerimaan Laporan

IPC

QC

21/11/2012
21/11/2012
21/11/2012
28/11/12

4/12/2012
10/12/2012
10/12/2012
3/12/2012

21/11/2012
21/11/2012
1/12/2012
1/12/2012
1/12/2012

3/12/2012
13/12/12
13/12/12
10/12/2012
10/12/2012

4/12/2012
30/11/2012

3/12/2012
10/12/2012
10/12/2012
10/12/2012
10/12/2012

Disolusi TMS

Disolusi TMS
Disolusi TMS

3/12/2012
3/13/2012
3/14/2012
3/15/2012
3/16/2012
3/17/2012
29/11/2012
29/11/2012
27/11/2012

10/12/2012
3/12/2012
3/12/2012
10/12/2012
3/12/2012
3/12/2012
10/12/2012
10/12/2012

1/12/2012
30/11/2012

28/11/2012
21/11/2012
27/11/2012
29/11/2012
30/11/2012
30/11/2012
28/11/2012
1/12/2012
29/11/2012
29/11/2012
29/11/12

3/12/2012
7/12/2012

3/12/2012
3/12/2012
3/12/2012
3/12/2012
3/12/2012
3/12/2012

7/12/2012

Kesimpulan Hasil
IPC

QC

Ditolak
Diluluskan
Diluluskan
Ditolak

Ditolak
Ditolak
Ditolak
Diluluskan

Ditolak
Dilululskan
Diluluskan
Diluluskan
Diluluskan

Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan

Diluluskan
Diluluskan

Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan

Ditolak
Ditolak
Ditolak
Ditolak
Ditolak
Ditolak
Ditolak
Ditolak
Ditolak

Diluluskan
Diluluskan
Diluluskan
Ditolak
Diluluskan
Diluluskan
Ditolak
Ditolak

Ditolak
Diluluskan

Diluluskan
Diluluskan
Diluluskan
Diluluskan
Ditolak
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Diluluskan
Ditolak

Diluluskan
Diluluskan

Diluluskan
Ditolak
Diluluskan
Diluluskan
Diluluskan
Diluluskan

Diluluskan

STABILITAS BULAN DESEMBER 2012

TANGGAL MASUK

No

Abjad

Nama

: 25 DESEMBER 2012
Suhu
40oC

Bets
IPC

Suhu
30oC
QC

IPC

QC

30

Acidblock 300 kaplet

TA 001

30

Alphamol 500 kaplet

18/12/08

10

Bevalex Cream
Bevalex Cream

TN 049
TD 056

2 tb

Dexmolex syr. 100 ml

TD 019

120 mL

Fluza kaplet

Gliseril Guaiacolat
Gentalex Cream
Gentalex Cream

Infatrim suspensi
Infatrim forte kaplet

UO 038
22/12/08

Lexapram syr 60 ml
Lexapram syr 60 ml
Lexapram tablet
Lexahist tablet
Lexcomet 16 mg tab

TN 042
US 036
20/12/08
UA 027
TO 003

Lexaprofen 400 kap

Lexicam 10 kapsul
Lexicam 20 kapsul
Lexagin kaplet

TO 008
UG 001
UG 001
UM 001

Molakrim
Molason Cream
Molavir Cream
Moladerm Cream
Molapect 15/60 ml
Molexflu syr 60 ml
Molexflu syr 60 ml
Molagit tab
Molaneuron tab
Molacort 0.5 tab

Trial
UA 006
UA 001
UA 010
TN 030
TN 020
TN 021
22/12/08
TS 009
TN 015

Molaflam tablet

Trial

24

16

TY 001
TO 006
UJ 001

TN 002

24

16

35

30
5g
5g

40

20

50 ml

120 ml
120 ml
20

20

40

36

30

30

46
20
40

120 ml
120 ml
120 ml
14
10
50

40

20
20
40

10
10
10
2 tb
7 gr
6 gr
10 g

36

24

Molasic kaplet

UA 006

36

24

Pritacort tablet 8/12/09

A(D&B : PET); B (D : MSDT; B : PET); C (WH & kekerasan) 20/20/10
Pritanol 100
UY 012
40
20

Vical Suspensi

TN 022

120 mL

Waktu

18 bln
48 bln

Keterangan

Pembagian SampelTanggal Penerimaan Laporan

IPC
QC
IPC
QC
tgl 20/11/12
tgl 21/11/12tgl 20/11/12

Ambil Sampel

pengemasan memenuhi
syarat
sampel yg diterima
alphamol 150 kaplet

12 bln
9 bln

3/1/2013

3/1/2013

23/1/13
23/1/13

5/1/2013
5/1/2013

12 bln

6 bln

11/1/2013
pengemasan tdk memenuhi
syarat

7/1/2013

18 bln
12 bln
9 bln

5/1/2013

2 bln
48 bln

3/1/2013
3/1/2013 13/2/2013

12 bln
3 bln
48 bln
6 bln
12 bln

7/1/2013
7/1/2013
15/1/13
30/1/12
30/1/12

12 bln
1 bln
1 bln
6 bln

5/1/2013
5/1/2013
pengemasan memenuhi
syarat

2 bln
6 bln
6 bln
6 bln
12 bln
12 bln
12 bln
48 bln
12 bln
12 bln
6 bln

2/1/2013

2/1/2013
28/12/12 31/1/2013
29/12/12 31/1/2013
29/12/12 30/1/12

5/1/2013

pengemasan memenuhi
syarat

3/1/2013
28/12/12
5/1/2013

30/1/12
4/1/2013
30/1/12
30/1/12
4/1/2013
9/1/2013
30/1/12

7/1/2013

30/1/12

6 bln

36 bln
6 bln
12 bln

28/12/12

2/1/2013

2/1/2013
2/1/2013

Kesimpulan Hasil
IPC

QC

ditolak

diluluskan

ditolak
ditolak

diluluskan
diluluskan
diluluskan

ditolak
diluluskan diluluskan

ditolak

diluluskan
diluluskan
diluluskan
diluluskan
diluluskan

ditolak
diluluskan
ditolak
diluluskan
diluluskan
diluluskan diluluskan
diluluskan diluluskan
ditolak
diluluskan

diluluskan
diluluskan
diluluskan
diluluskan
diluluskan
ditolak
diluluskan
diluluskan diluluskan
diluluskan diluluskan
ditolak

diluluskan

diluluskan

diluluskan

diluluskan
diluluskan