JIPS PHARMACEUTICAL PVT.

LTD
Plot No. E-13, Industrial Area, Phase 7, SAS Nagar, Punjab

Temp: 400 C + 20 C RH: 75%±5%

SUMMARY OF ACCELERATED STABILITY DATA

PRODUCT NAME : Vortioxetine Hydrobromide 5 mg Tablets GENERIC NAME : Vortioxetine Hydrobromide 5 mg Tablets
Batch No. : Trial II Batch size : 1000 Tablets Shelf life : 24 Months
Mfg. Date : 05/2022 Exp. Date : 04/2024 Start Date : 03/05/2022

Sr. Tests Specification 00 03rd 06th

No.
1. Description: White colored, round shape, biconvex, Ok Ok Ok
scored on one side and another side is plain, each
film coated tablet. (No variation found) (No variation found) (No variation found)

2. Average Weight: 220 mg 220.89 mg 220.83 mg 221.58 mg

3. Disintegration Test: - NMT - 30 minutes 08 minutes 57 seconds 08 minutes 52 seconds 08 minutes 55 seconds

4. Assay: Each film coated tablet contains : -

Vortioxetine Hydrobromide
Eq. to Vortioxetine 5 mg 100.09% 99.68% 99.09%
Limit : 90 % to 110 %

Analysed By: Checked by:

Conclusion: The drug product found to be stable/ unstable at above specified conditions for Period evaluated of …6… months data.

SUMMARY OF LONG TERM STABILITY DATA

GENERIC NAME : Vortioxetine Hydrobromide 5 mg Tablets
PRODUCT NAME: Vortioxetine Hydrobromide 5 mg Tablets
.
 JIPS PHARMACEUTICAL PVT.LTD
Plot No. E-13, Industrial Area, Phase 7, SAS Nagar, Punjab

Batch No. : Trial II Batch size : 1000 Tablets Shelf life : 24 Months
Mfg. Date : 05/2022 Exp. Date : 04/2024 Start Date : 300 03/05/2022
Temp: C ± 20 C RH: 65%± 5%

Duration ( In month) / Result

Sr. No. Tests Specification 00 03rd 06th 09th 12th 18th 24th

1. Description: White colored, round shape, Ok Ok Ok

biconvex, scored on one side and another
side is plain, each film coated tablet. (No variation (No variation (No variation
found) found) found)

2. Average Weight: 220 mg 221.59 mg 221.43 mg 220.92 mg

3. Disintegration Test : NMT- 30 minutes 08 minutes 55 08 minutes 54 08 minutes 53

seconds seconds seconds

4. Assay: Each film coated tablet contains :

Vortioxetine Hydrobromide
Eq. to Vortioxetine 5 mg 100.38% 99.74% 99.26%
Limit : 90 % to 110 %

Analysed By: Checked by:

Conclusion: The drug product found to be stable/ unstable at above specified conditions for Period evaluated of ……… months data.