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 Enrofloxacin 10% Vet Oral solution Mfg. date 03. 04.19
Strength Each ml contains Enrofloxacin BP 100 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-01 Packaging mode 100 ml solution containing in
plastic bottle with plastic cap.
Batch size 5 Liter Storage date 06. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(06.04.19) (07.07.19) (09.10.19)
01. Appearance A clear, light yellow colored solution Complies Complies Complies

02. Identification Test must be positive for Enrofloxacin Positive Positive Positive

03. pH 10.5 to 11.5 10.81 10.83 10.82

04. Leak test Must be 100% leak proof Passed Passed Passed

05. Assay 90.0% to 110.0% of the labeled amount of Enrofloxacin 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 Enrofloxacin 10% Vet Oral solution Mfg. date 06. 04.19
Strength Each ml contains Enrofloxacin BP 100 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-02 Packaging mode 100 ml solution containing in
plastic bottle with plastic cap.
Batch size 5 Liter Storage date 08. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(08.04.19) (09.07.19) (10.10.19)
01. Appearance A clear, light yellow colored solution Complies Complies Complies

02. Identification Test must be positive for Enrofloxacin Positive Positive Positive

03. pH 10.5 to 11.5 10.81 10.83 10.82

04. Leak test Must be 100% leak proof Passed Passed Passed

05. Assay 90.0% to 110.0% of the labeled amount of Enrofloxacin 100.96% 100.46% 99.61%

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 Enrofloxacin 10% Vet Oral solution Mfg. date 10. 04.19
Strength Each ml contains Enrofloxacin BP 100 mg Storage condition i) Temperature : 40°C ± 2° C
ii) RH : 75% ± 5%
Batch No. T-03 Packaging mode 100 ml solution containing in
plastic bottle with plastic cap.
Batch size 5 Liter Storage date 15. 04.19

Sl. Test Specifications Results

No. Parameters Initial 3 Months 6 Months
(15.04.19) (16.07.19) (24.10.19)
01. Appearance A clear, light yellow colored solution Complies Complies Complies

02. Identification Test must be positive for Enrofloxacin Positive Positive Positive

03. pH 10.5 to 11.5 10.83 10.84 10.83

04. Leak test Must be 100% leak proof Passed Passed Passed

05. Assay 90.0% to 110.0% of the labeled amount of Enrofloxacin 102.14% 101.47% 100.53%

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