Form No. : PD-F00-00 Effective date : 00-00-00 Version No.

: 00

GENTRY PHARMACEUTICALS LTD.

VANGNAHATI, SREEPUR, GAZIPUR
Product Development Department

ACCELERATED STABILITY STUDY REPORT

(AS PER ICH GUIDELINE)
Product Name Marbofloxacin Bolus Mfg. date 09. 04.19
Strength Each bolus contains Marbofloxacin BP 50 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-01 Packaging mode Alu/Alu blister strip pack
Batch size 1000 bolus Storage date 11. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(11.04.19) (13.07.19) (13.10.19)
01. Appearance A white, elongated bolus having embossed ‘GENTRY’ on Complies Complies Complies
one side and a break line on other side.
02. Identification Test must be positive for Marbofloxacin Positive Positive Positive

03. LOD 3.0% to 4.0% 3.35% 3.36% 3.37%

04. Hardness 3.0 to 6.0 Kg/cm2 5.0 Kg/cm2 4.5 Kg/cm2 4.5 Kg/cm2

05. Disintegration Not more than 15 minutes 7.0 min. 7.0 min. 6.5 min.
Time
06. Leak test Must be 100% leak proof Passed Passed Passed

07. Assay 90.0% to 110.0% of the labeled amount of Marbofloxacin 101.46% 101.07% 100.63%

Conclusion : All test results comply with the specifications up to 06 (six) months at accelerated condition and no significant changes are observed. Based on 06 (six)
months satisfactory accelerated stability study results, shelf life of this product can be proposed for 02 (two) years at a temperature not exceeding 30ºC.
Long term (real time) stability study will be continued up to proposed shelf life from three consecutive process validation batches.

Prepared by: Checked by : Approved by:

Sr. Executive, PD Sr. Officer, QA Manager, QA

Form No. : PD-F00-00 Effective date : 00-00-00 Version No. : 00

GENTRY PHARMACEUTICALS LTD.

VANGNAHATI, SREEPUR, GAZIPUR
Product Development Department

ACCELERATED STABILITY STUDY REPORT

(AS PER ICH GUIDELINE)
Product Name Marbofloxacin Bolus Mfg. date 11. 04.19
Strength Each bolus contains Marbofloxacin BP 50 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-02 Packaging mode Alu/Alu blister strip pack
Batch size 1000 bolus Storage date 12. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(12.04.19) (15.07.19) (17.10.19)
01. Appearance A white, elongated bolus having embossed ‘GENTRY’ on Complies Complies Complies
one side and a break line on other side.
02. Identification Test must be positive for Marbofloxacin Positive Positive Positive

03. LOD 3.0% to 4.0% 3.35% 3.36% 3.37%

04. Hardness 3.0 to 6.0 Kg/cm2 5.0 Kg/cm2 4.5 Kg/cm2 4.5 Kg/cm2

05. Disintegration Not more than 15 minutes 7.0 min. 7.0 min. 6.5 min.
Time
06. Leak test Must be 100% leak proof Passed Passed Passed

07. Assay 90.0% to 110.0% of the labeled amount of Marbofloxacin 101.46% 101.07% 100.63%

Conclusion : All test results comply with the specifications up to 06 (six) months at accelerated condition and no significant changes are observed. Based on 06 (six)
months satisfactory accelerated stability study results, shelf life of this product can be proposed for 02 (two) years at a temperature not exceeding 30ºC.
Long term (real time) stability study will be continued up to proposed shelf life from three consecutive process validation batches.

Prepared by: Checked by : Approved by:

 Sr. Executive, PD Sr. Officer, QA Manager, QA
Form No. : PD-F00-00 Effective date : 00-00-00 Version No. : 00

GENTRY PHARMACEUTICALS LTD.

VANGNAHATI, SREEPUR, GAZIPUR
Product Development Department

ACCELERATED STABILITY STUDY REPORT

(AS PER ICH GUIDELINE)
Product Name Marbofloxacin Bolus Mfg. date 16. 04.19
Strength Each bolus contains Marbofloxacin BP 50 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-02 Packaging mode Alu/Alu blister strip pack
Batch size 1000 bolus Storage date 17. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(17.04.19) (20.07.19) (21.10.19)
01. Appearance A white, elongated bolus having embossed ‘GENTRY’ on Complies Complies Complies
one side and a break line on other side.
02. Identification Test must be positive for Marbofloxacin Positive Positive Positive

03. LOD 3.0% to 4.0% 3.35% 3.36% 3.37%

04. Hardness 3.0 to 6.0 Kg/cm2 5.0 Kg/cm2 4.5 Kg/cm2 4.5 Kg/cm2

05. Disintegration Not more than 15 minutes 7.0 min. 7.0 min. 6.5 min.
Time
06. Leak test Must be 100% leak proof Passed Passed Passed

07. Assay 90.0% to 110.0% of the labeled amount of Marbofloxacin 101.46% 101.07% 100.63%

Conclusion : All test results comply with the specifications up to 06 (six) months at accelerated condition and no significant changes are observed. Based on 06 (six)
months satisfactory accelerated stability study results, shelf life of this product can be proposed for 02 (two) years at a temperature not exceeding 30ºC.
Long term (real time) stability study will be continued up to proposed shelf life from three consecutive process validation batches.

Prepared by: Checked by : Approved by:

Sr. Executive, PD Sr. Officer, QA Manager, QA