ASIAANIMALPHARMACEUTICALCO.

,LTD

Address:No.130-1AHighway-BaLangWard-CaiRangDistrict
- Can Tho City - Viet Nam

Tel: (+84) (0710) 391 3347

Fax: (+84) (0710) 391 3349

PRODUCT STABILITY STUDY

PRODUCT : THIAMSONE

TYPE : SOLUTION FOR INJECTION

1
 SUMMARY SHEET

A-Batches of study
Initiation Dateof Study : June 10,2010

Acceleratedstudies √ Real-timestudies√ In-use studies√

Name of drug product : THIAMSONE

Manufacturer : ASIA ANIMAL PHARMACEUTICAL
Address : 130 – 1A highway, Ba Lang ward, Cai Rang
district, Can Tho city, Vietnam
Active ingredient : Thiamphenicol,Oxytetracycline,
Dexamethasone
Dosage form : Injection
Packing : 100 ml
Detailed Description of Primary Pack: Clear, glass bottle with butyl rubber
closure and aluminium-plastic composite cap

Batch number Date of manufacture Expiry date

1- PL0110 June 10th, 2010 June 10th, 2013
2- PL0210 June 11th, 2010 June 11th, 2013
3- PL0310 June 12th, 2010 June 12th, 2013

Shelf life: 36 months

Batch size Type of batch (experimental, Pilot Batch,production)

1- 50L Pilot batch
2- 50L Pilotbatch
3- 50L Pilotbatch

Samples tested (per batch): 30 bottles

Storage / test conditions: Accelerated study Long term study In-use stability
Temperature 40±2°C 30± 2°C 30± 2°C
Humidity 75±5 %RH 65±5 % RH 65±5 % RH

2
 B- Results
1-Chemical findings
a) pH

pH
Storage condition
PL0110 PL0210 PL0310
Initial values 6.1 6.2 6.2
3 months, 40±2°C / 75±5 %RH 6.1 6.1 6.2
3 months, 30±2°C / 65±5 %RH 6.1 6.2 6.0
6 months, 40±2°C / 75±5 %RH 6.3 6.3 6.3
6 months, 30±2°C / 65±5 %RH 6.1 6.2 6.1
9 months, 30±2°C / 65±5 % RH 6.3 6.5 6.3
12 months, 30±2°C / 65±5 % RH 6.4 6.5 6.5
18 months, 30±2°C / 65±5 % RH 6.6 6.5 6.5
24 months, 30±2°C / 65±5 % RH 6.6 6.7 6.6
36 months, 30±2°C / 65±5 % RH 6.8 6.7 6.8

o In-use stability

pH
Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH 6.1 6.2 6.2
5 days, 30±2°C / 65±5 % RH 6.2 6.4 6.4
10 days, 30±2°C / 65±5 % RH 6.4 6.5 6.6
14 days, 30±2°C / 65±5 % RH 6.7 6.5 6.8

b) Particulate matter

Particulate matter
Storage condition
PL0110 PL0210 PL0310
Initial values Complies Complies Complies
3 months, 40±2°C / 75±5 %RH Complies Complies Complies
3 months, 30±2°C / 65±5 %RH Complies Complies Complies
6 months, 40±2°C / 75±5 %RH Complies Complies Complies
6 months, 30±2°C / 65±5 %RH Complies Complies Complies
9 months, 30±2°C / 65±5 % RH Complies Complies Complies
12 months, 30±2°C / 65±5 % RH Complies Complies Complies
18 months, 30±2°C / 65±5 % RH Complies Complies Complies
24 months, 30±2°C / 65±5 % RH Complies Complies Complies
36 months, 30±2°C / 65±5 % RH Complies Complies Complies

3
 o In-use stability

Particulate matter
Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH Complies Complies Complies
5 days, 30±2°C / 65±5 % RH Complies Complies Complies
10 days, 30±2°C / 65±5 % RH Complies Complies Complies
14 days, 30±2°C / 65±5 % RH Complies Complies Complies

c) Uniformity of dosageunit

Uniformity of dosage unit

Storage condition
PL0110 PL0210 PL0310
Initial values Uniform Uniform Uniform
3 months, 40±2°C / 75±5 %RH Uniform Uniform Uniform
3 months, 30±2°C / 65±5 %RH Uniform Uniform Uniform
6 months, 40±2°C / 75±5 %RH Uniform Uniform Uniform
6 months, 30±2°C / 65±5 %RH Uniform Uniform Uniform
9 months, 30±2°C / 65±5 % RH Uniform Uniform Uniform
12 months, 30±2°C / 65±5 % RH Uniform Uniform Uniform
18 months, 30±2°C / 65±5 % RH Uniform Uniform Uniform
24 months, 30±2°C / 65±5 % RH Uniform Uniform Uniform
36 months, 30±2°C / 65±5 % RH Uniform Uniform Uniform

o In-use stability

Uniformity of dosage unit

Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH Uniform Uniform Uniform
5 days, 30±2°C / 65±5 % RH Uniform Uniform Uniform
10 days, 30±2°C / 65±5 % RH Uniform Uniform Uniform
14 days, 30±2°C / 65±5 % RH Uniform Uniform Uniform

c) Content

Content (%) of Thiamphenicol

Storage condition
PL0110 PL0210 PL0310
Initial values 100.3 100.3 100.5
3 months, 40±2°C / 75±5 %RH 98.4 98.6 97.4
3 months, 30±2°C / 65±5 %RH 100.2 99.9 100.2
6 months, 40±2°C / 75±5 %RH 96.8 96.1 95.6
6 months, 30±2°C / 65±5 %RH 99.5 99.2 99.3
9 months, 30±2°C / 65±5 % RH 98.4 98.6 98.4
12 months, 30±2°C / 65±5 % RH 97.7 97.9 97.2

4
18 months, 30±2°C / 65±5 % RH 96.8 97.1 96.6
24 months, 30±2°C / 65±5 % RH 96.1 96.4 95.7
36 months, 30±2°C / 65±5 % RH 95.2 95.9 95.2

o In-use stability

Content (%) of Thamphenicol

Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH 100.3 100.3 100.5
5 days, 30±2°C / 65±5 % RH 98.9 98.9 98.7
10 days, 30±2°C / 65±5 % RH 96.3 97.7 96.2
14 days, 30±2°C / 65±5 % RH 95.1 95.3 95.0

Tendency of the content of Thiamphenicol is as follows:

Content (%) of Thiamphenicol

101
100
Content (%)

99
98
97 PL0110
96 PL0210
95
PL0310
94
Initial 3 6 9 12 18 24 36
values

Time (month)

Content (%) of Oxytetracycline

Storage condition
PL0110 PL0210 PL0310
Initial values 99.9 100.2 100.0
3 months, 40±2°C / 75±5 %RH 99.5 98.2 97.8
3 months, 30±2°C / 65±5 %RH 99.7 99.9 99.7
6 months, 40±2°C / 75±5 %RH 99.0 96.4 95.8
6 months, 30±2°C / 65±5 %RH 99.5 99.4 98.9
9 months, 30±2°C / 65±5 % RH 98.6 98.2 98.2
12 months, 30±2°C / 65±5 % RH 98.1 97.1 97.7
18 months, 30±2°C / 65±5 % RH 97.1 96.4 97.0
24 months, 30±2°C / 65±5 % RH 96.2 95.9 96.3
36 months, 30±2°C / 65±5 % RH 95.4 95.3 95.5
5
 o In-use stability

Content (%) of Oxytetracycline

Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH 99.9 100.2 100.0
5 days, 30±2°C / 65±5 % RH 98.4 98.8 98.2
10 days, 30±2°C / 65±5 % RH 96.9 96.7 96.7
14 days, 30±2°C / 65±5 % RH 95.1 95.1 95.0

Tendency of the content of Oxytetracycline is as follows:

Content (%) of Oxytetracycline

101
100
Content (%)

99
98
97 PL0110
96 PL0210
95 PL0310
94
Initial 3 6 9 12 18 24 36
values

Time (month)

Content (%) of Dexamethasone

torage condition
PL0110 PL0210 PL0310
Initial values 102.7 104.2 101.9
3 months, 40±2°C / 75±5 %RH 99.7 100.9 98.4
3 months, 30±2°C / 65±5 %RH 101.4 103.7 100.1
6 months, 40±2°C / 75±5 %RH 97.4 98.2 96.9
6 months, 30±2°C / 65±5 %RH 100.5 102.2 99.2
9 months, 30±2°C / 65±5 % RH 99.7 100.9 98.4
12 months, 30±2°C / 65±5 % RH 98.5 99.8 97.7
18 months, 30±2°C / 65±5 % RH 97.4 98.2 96.9
24 months, 30±2°C / 65±5 % RH 96.6 97.7 96.0
36 months, 30±2°C / 65±5 % RH 95.7 96.1 95.2

6
 o In-use stability

Content (%) of Dexamethasone

Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH 102.7 104.2 101.9
5 days, 30±2°C / 65±5 % RH 100.7 100.0 99.5
10 days, 30±2°C / 65±5 % RH 98.4 98.6 97.6
14 days, 30±2°C / 65±5 % RH 96.9 96.1 95.1

Content (%) of Dexamethasone

106
Content (%)

104
102
100
PL0110
98
PL0210
96
PL0310
94
Initial 3 6 9 12 18 24 36
values

Time (month)

2- Microbiological and biological findings

Sterility
Storage condition
PL0110 PL0210 PL0310
Initial values Negative Negative Negative
3 months, 40±2°C / 75±5 %RH Negative Negative Negative
3 months, 30±2°C / 65±5 %RH Negative Negative Negative
6 months, 40±2°C / 75±5 %RH Negative Negative Negative
6 months, 30±2°C / 65±5 %RH Negative Negative Negative
9 months, 30±2°C / 65±5 % RH Negative Negative Negative
12 months, 30±2°C / 65±5 % RH Negative Negative Negative
18 months, 30±2°C / 65±5 % RH Negative Negative Negative
24 months, 30±2°C / 65±5 % RH Negative Negative Negative
36 months, 30±2°C / 65±5 % RH Negative Negative Negative

7
 3- Physical findings

a) Appearance

Appearance
Storage condition
PL0110 PL0210 PL0310
Initial values Clear brown-red Clear brown-red Clear brown-red
solution solution solution
3 months, 40±2°C / 75±5 %RH Clear brown- Clear brown- Clear brown-
redsolution redsolution redsolution
3 months, 30±2°C / 65±5 %RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
6 months, 40±2°C / 75±5 %RH Clear brown- Clearbrown-red Clear brown-red
redsolution solution solution
6 months, 30±2°C / 65±5 %RH Clear brown- Clearbrown-red Clear brown-red
red solution solution solution
9 months, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
12 months, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
18 months, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
24 months, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
36 months, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution

o In-usestability

Appearance
Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
5 days, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
10 days, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution
14 days, 30±2°C / 65±5 % RH Clear brown-red Clear brown-red Clear brown-red
solution solution solution

8
 b) Volume

Volume (ml)
Storage condition
PL0110 PL0210 PL0310
Initial values 100 100 100
3 months, 40±2°C / 75±5 %RH 100 100 100
3 months, 30±2°C / 65±5 %RH 100 100 100
6 months, 40±2°C / 75±5 %RH 100 100 100
6 months, 30±2°C / 65±5 %RH 100 100 100
9 months, 30±2°C / 65±5 % RH 100 100 100
12 months, 30±2°C / 65±5 % RH 100 100 100
18 months, 30±2°C / 65±5 % RH 100 100 100
24 months, 30±2°C / 65±5 % RH 100 100 100
36 months, 30±2°C / 65±5 % RH 100 100 100

o In-usestability

Volume (ml)
Storage condition
PL0110 PL0210 PL0310
0 day , 30±2°C / 65±5 % RH 100 100 100
5 days, 30±2°C / 65±5 % RH 86 89 85
10 days, 30±2°C / 65±5 % RH 75 76 72
14 days, 30±2°C / 65±5 % RH 69 71 67

C-Conclusions

Shelf life : 36 months.

In-use shelf : 14 days.
Storage condition : Store below 30°C.