Stability Data

Globela Pharma Put, Ltd
GC
Globela Pharma Pvt. Ltd.

357, G.1.D.C. Sachin Surat — 394 230
Gujarat (India)
QUALITY CONTROL DEPARTMENT ACCELERATED

STABILITY STUDY SUMMARY REPORT
Product Abiraterone Acetate Tablet USP 250 mg | BatchNo | PDO18807 | Batch Size |
10,000 Tablets
. Primary packing Bottle pack of 120 Tablets Date of manufacturing 07/2018
Packaging Procedure Secondary packing | One bottle is packed in one printed carton
Date of Expiry 06/2020
Storage Condition The Simulated Market Packs are kept in Humidity Chamber at 40%C +
2*C Temperature and 75% +5% Relative Humidity for | Date of Commencement of Study
01/08/2018
9 06 Months Date of Completion of Study 08/02/2019
Teason " Stability Study ( 1) Product manufactured first time 2) Formulation Change
3) Packing materials change, 4) Regulatory requirements 5) Process change6)
Equipments change
SN Test Specification (s) 8% Initial 01 Month 02 Month 03 Month 06 Month _
es Due date > 25-07-2018 01-09-2018 01-10-2018 01-11-2018 01-02-2019
1 Description E eMoured oval shaped uncoated tablet, having both side Complies
Complies Complies Complies Complies
The retention time of the major peak of the Sample
AL A) solution corresponds to that of the Standard solution, as Complies Complies
Complies Complies Complies
2 Identification obtained in the Assay.
The UV spectrum of the major peak of the Sample
Solution corresponds to that of the Standard solution, as Complies Complies
obtained in the Assay. —|
3 Weight of 20 tablets 14.3000 gm +5% 14.3521 gm 14.3852 gm 14.3240gm 14.4510 gm
14.4025 gm
4 Average Weight of tablet 0.7150 gm +5% 0.7176 gm 0.7192 gm 0.7197 gm 0.7225 gm —
0.7201 gm
: - . Not more than 2 tablets of 20 tablet sample should deviated from . . . . .
5 | Uniformity of weight the avg.wt.by more than 5 % Complies Complies Complies
Complies ome: |
6 Disintegration Time Not more than 15 minutes 5 min 11 sec 6 min 04 sec 7 min 15
sec 8 min 41 sec_ | 10 min06sec
7 Length 16.0 mm +0.2 mm 16.15 mm 16.09 mm 16.11 mm 16.15 mm 16.00 mm
8 Breadth 9.5 mm + 0.2 mm 9.52 mm 92.52 mm 9.50 mm 9.52 mm 9.52 mm
9 Thickness 6.0 + 0.3 mm 6.28 mn 6.28 mm 6.28 mn 6.18 mm 6.09 mm
10 | Hardness Not less than 3.0 kg / cm” 3.0 kg/em? 3.5 kg/em? 4.0 kg/em? 4.5
kg/em* 4.5 kg/em-
11 Friability Not more than 1.0% 0.22 % 0.27 % 0.28 % 0.30 % 0.32 %
a A
12 | Dissolution test (een SE NT mE TER OE TES 90.35% 90.00% 89.55% 89.10% 88.45%
CzeHasNO>) is dissolved in 45 Min.
7-Ketoabiraterone acetate Not more than 0.50% 0.06% 0.06% 0.07% 0.07% — 0.08%
a Epoxyabiraterone acetate Not more than 0.80% 0.04% 0.05% 0.05% 0.05% 0.09%
13 | Organic Impurit B Epoxyabiraterone acetate Not more than 0.80% 0.08% 0.09%
0.09% 0.09% 0.11%
E Eo Abiraterone Not more than 0.40% 0.09% 0.09% 0.12% 0.16% 0.19%
Unspecified impurity Not more than 0.20% 0.08% 0.09% 0.09% 0.09% — 010%
Total Impurity Not more than 2.00% 0.35% 0.38% 0.42% 0.46% 0.57%
Uniformity of dosage unit o o o o o o
14 (By Uniformity of Content ) Acceptance value (AV) should be not more than 15%
3.15% 3.21% 3.64% 4.02% 4.06%
Assay: Each uncoated tablet Abiraterone Acetate Tablets contain NLT 90.0% and NMT
15 | contains: 110.0% of the labeled amount of Abiraterone acetate 101.5% 101.1%
100.6% 99.29% 98.4%
Abiraterone Acetate USP 250 mg (CzeHs3NO2).
Mcconmiles <10% CFU /g 45 CFU/g 45 CFU /g 50 CFU /g 54 CFU /g 65 CFU /g
16 | Microbial Limit — | yeast 8 Fungus | <10”CFU/g _ <10 CFU/g <10 CFU/g <10 CFU 9
<10 CFU/g <10 CFU 7g
Escherichia coli _ | Should be Absent /g Absent/g Absent /g Absent /g Absent /g
Absent /g
Salmonella Should be Absent / 10 q Absent / 10 g Absent / 10g Absent / 10 g Absent/
10g Absent / 10g
Prepared By: Checked By: _, Approved By:
Sign. E
Name | Ms. Sejal Patel Mrs. Ufa Patel Mr. Hemant Kulkarni
Designation
Q.C. Executive
Q.C. Manager
Q.A. Manager
G
|
357, G.1.D.C. Sachin Surat — 394 230

Gilobel: Pharma Gujarat (India)

mo. Specification (s) 8 Initial 01 Month 02Month | O03Month | 06Month
Due date > 25-07-2018 01-09-2018 01-10-2018 | 01-11-2018 01-02-2019
P. aureginosa Should Se Absent /g Absent /g Absent /c Absent /g Absent /g Absent /g
S. aureas Should be Absent /g Absent /g Absent /a Absent /g Absent /g Absent /g
- E ¡ZE Sign. — Y — 86 a ra E
Analysis by | —__Vikas Vikas Vivek Vivek | Vikas
= Date of Analysis 01-08-2018 08-09-2018 08-10-2018 08-11-2018 08-02-2019
Remarks: The Product Complies /Does-net+-Comgplies with the laid down
Specifications and Significant-Change / No Significant Change is Observed and No
evidence for any Major Degradation of Accelerated
Stability Study after _06__ Months
Prepared By: Checked By: Approved By:
Sign. ML
Name | Ms. Sejal Patel $ha Patel Mr. Hemant Kulkarni

Q.C. Executive Q.C. Manager Q.A. Manager
Designation
.
n*
-
CNCA ec QUALITY CONTROL DEPARTMENT ACCELERATED

2 e SEE SUFat— STABILITY STUDY SUMMARY REPORT
Globela Pharma | Gujarat (India) |
Product | Abiraterone Acetate Tablet USP 250 mg o | BatchNo | PDO18808 | Batch Size
| 10,000 Tablets
Packaging | Primary packing | Bottle pack of 120 Tablets Date of manufacturing
07/2018
Procedure Secondary packing | One bottle is packed in one printed carton Date of
Expiry 06/2020
Storage The Simulated Market Packs are kept in Humidity Chamber at 40%C +2*C
Temperature and 75% +5% Relative Humidity for | Date of Commencement of Study
01/08/2018
Condition 06 Months Date of Completion of Study 08/02/2919
Reason E Stability Study ( 1) Product manufactured first time 2) Formulation Change
Equipments change
SN Test Specification (s) 8 Initial 01 Month 02 Month 03 Month | 06 Month
es Due date > 25-07-2018 01-09-2018 01-10-2018 01-11-2018 | 01-02-2019
1 Description va colored oval shaped uncoated Tablet, having both side Complies
| The retention time of the major peakof the Sample solution
A corresponds to that of the Standard solution, as obtained in Complies Complies
2 Identification | the Assay.
The UV spectrum of the major peak of the Sample solution
| B corresponds to that of the Standard solution, as obtained in Complies Complies
the Assay. ]
3 Weight of 20 tablets 14.3000 gm + 5% 14.4025 gm 14.4122 gm 14.3895 gm | 14.3874
gm 14.3958 gm
4 | Average Weight of tablet 0.7150 gm + 5% 0.7201 gm 0.7206 gm 0.7194 gm | 0.7193
9m 0.7197 gm
| . ; Not more than 2 tablets of 20 tablet sample should deviated a n ;
5 Uniformity of weight “from the avg.w.by more than 5 % __ o _ Complies NEETIEES
6 Disintegration Time Not more than 15 minutes 5 min 25 sec 6 min 13sec 7 min 23sec
8 min 31sec_ | 9 min 10sec
7 Length 16.0 mm + 0.2 mm 16.06 mm 16.12 mm 16.00 mm 16.03 mm 16.00 mm
8 _| Breadth 9.5 mm + 0.2 mm 9.52 mm 9.52 mm _—_9.52 mm 9.54 mm 9.850 mm
9 Thickness | 6.0 + 0.3 mm 6.18 mm 6.08 mm 6.28 mm 6.12 mm 6.17 mm
10 | Hardness | Notless than 3.0 kg/cm? 3.0 kg/em? 3.5 kg/em? 4.0 kg/em? 4.5 kg/em?
4.5 kg/em-
11 | Friability Not more than 1.0% 0.21 % 0.24 % 0.28 % 0.33 % 0.37 %
; ; NLT 85% (Q) of the labeled amount of Abiraterone acetate S S 5 S S
12 | Dissolution test (CasHasNO') is dissolved in 45 Min. 91.90% 91.49% 90.84%
90.10% 89.20%
| 7-Ketoabiraterone acetate Not more than 0.50% 0.03% 0.06% 0.06% 0.08% 0.10%
a Epoxyabiraterone acetate Not more than 0.80% 0.02% 0.04% 0.05% = 0.07% 0.09% |
13 Organic B Epoxyabiraterone acetate Not more than 0.80% 0.00% 0.06% 0.08% 0.09%
0.11% a
Impurity Abiraterone Not more than 0.40% 0.07% 0.07% 0.08% 0.09% 0.13% |
Unspecified impurity Not more than 0.20% 0.06% 0.07% 0.07% — 0.09% 0.10% |
— o Total Impurity — | Not more than 2.00% 0244 0.31% 0.34% 0.42% 0.53% |
Uniformity of dosage unit 0
2.49% 3.05% 3.13% 4.08% 4.35%
AT Abiraterone Acetate Tablets contain NLT 90.0% and NMT
g !
15 Abiraterone Acetate USP....250 110.0% of the labeled amount of Abiraterone
acetate 100.2% 99.8% 99.2% 98.8% 98.3%
(CaoHaaNO2).
mg
Prepared By: Checked By: Appfoved By:
Sign. ZA -
Name | Ms. Sejal Patel Mrs. Usha Patel Mr. Hemant Kulkarni
Designation | Q.C. Executive Q.C. Manager Q.A. Manager ———_
e

357, G.1.D.C. Sachin Surat — 394 230
Gujarat (India)
SN Test Specification (s) 6 Initial 01 Month 02 Month 03 Month 06 Month

Due date > 25-07-2018 01-09-2018 01-10-2018 01-11-2018 01-02-2019
E <10? CFU 1g 45 CFU /g 45 CFU /g 50 CFU /g 55 CFU /g 65 CFU /g
. 1. . | Yeast 8 Fungus <10* CFU /g <10 CFU /g <10 CFU /g <10 CFU /g <10 CFU /g <10
CFU /g
16 Merobia Limit Escherichia coli | Should be Absent /g Absent /g Absent/g Absent/g

Absent/g Absent /g
Salmonella Should be Absent /10 g Absent 10 g Absent 10 g Absent 10 g Absent 0 g
Absent 10 g
P. aureginosa Should be Absent/g Absent /g Absent/g Absent /g Absent /g Absent /g
S. aureas Should be Absent /g Absent/g Absent/g Absent /g Absent/g__ Absent /

Sign. — Ta “ |
E Analysis by Vikas Vikas Vivek Vivek Vikas
Date of Analysis 01-08-2018 08-09-2018 08-10-2018 08-11-2018 08-02-2019
Remarks: The Product Complies /Dees-net-Cemplies with the laid down Specifications
and Significant-Change / No Significant Change is Observed and
Stability Study after _06__ Months
No evidence for any Major Degradation of Accelerated
Prepared By: Checked By: raved By:

Sign. | 7 Ye
Name | Ms. Sejal Patel Me/USha Patel Mr. Hemant Kulkarni
Designation Q.C. Executive Q.C. Manager Q.A. Manager
q
Giobela Pharma Pyt. Ltd.

357, G.1.D.C. Sachin Surat — 394 230
Gujarat (India)

10,000 Tablets
Packaging Primary packing | Bottle pack of 120 Tablets Date of manufacturing
07/2018
Procedure Secondary packing _| One bottle is packed in one printed carton Date of
Expiry 06/2020
Storage The Simulated Market Packs are kept in Humidity Chamber at 40*%C +2*C
Temperature and 75% +5% Relative Humidity for | Date of Commencement of Study
01/08/2018
Condition 06 Months Date of Completion of Study 08/02/2019
Reason 7 Stability Study ( 1) Product manufactured first time 2) Formulation Change
Equipments change
| Due date > 25-07-2018 01-09-2018 01-10-2018 01-11-2018 01-02-2019
La
1 Description Ma colored oval shaped uncoated Tablet, having both side Complies
The retention time of the major peak of the Sample solution
A corresponds to that of the Standard solution, as obtained in Complies Complies
> | Identification the Assay. — —_
The UV spectrum of the major peak of the Sample solution
B corresponds to that of the Standard solution, as obtained in Complies Complies
the Assay.
3 Weight of 20 tablets 14.3000 gm + 5% 14.3850 gm 14.3855 gm 14.4025 gm 14.3987 gm
14.3258 gm
4 | Average Weight of tablet 0.7150 gm + 5% 0.7192 gm 0.7192 gm 0.7201 gm 0.7199 gm
0.7162 gm
- - - Not more than 2 tablets of 20 tablet sample should deviated - - - . -
5 Uniformity of weight from the avg.wt.by more than 5 % Complies Complies Complies
Complies Complies
6 Disintegration Time Not more than 15 minutes 5 min 21 sec 6 min 13 sec 7 min 21
sec 8 min 26 sec 9 min 16 sec
7 | Length 16.0 mm +0.2mm 16.16 mm 16.12 mm 16.02 mm 16.00 mm 16.16 mm
8 Breadth 9.5 mm + 0.2mm 9.52 mm 9.52 mm 9.58 mm 9.54 mm 9.54 mm
9 | Thickness 6.0 + 0.3 mm 6.08 mm 6.02 mm 6.00 mm 6.00 mm 6.12 mm
10 | Hardness E. | Notless than 3.0 kg/ em? 3.0 kg/em? 3.5 kg/em? 3.5 kg/em? 3.5
kg/cm? 4.0 kg/cm-
11 | Friability Not more than 1.0% 0.27 % 0.20 % 0.29% 0.21% 0.29 %
; ; NLT 85% (Q) of the labeled amount of Abiraterone acetate o o o o o
12 | Dissolution test (CasHssNO) is dissolved in 45 min. 92.85% 91.20% 90.15%
89.60% 88.85%
7-Ketoabiraterone acetate Not more than 0.50% 0.05% 0.06% 0.08% 0.09% 0.17%
a Epoxyabiraterone acetate Not more than 0.80% 0.02% 0.04% 0.07% 0.08% 0.09%
0.11%
Impurity Abiraterone Not more than 0.40% 0.08% 0.09% 0.13% 0.17% — 0.19%
Unspecified impurity Not more than 0.20% 0.06% 0.08% 0.09% 0.09% 0.10%
Total Impurity Not more than 2.00% 0.28% 0.28% 0.46% 0.52% 0.68%
Uniformity of dosage unit
3.45% 4.09% 4.16% 427% 4.37%
AO pco ED Abiraterone Acetate Tablets contain NLT 90.0% and NMT
: o !
15 Abiraterone Acetate USP....250 110.0% of the labeled amount of Abiraterone
acetate 100.9% 100.1% 98.5% 97.9% 97.3%
(CosHssNO>).
mg
Prepared By: Checked By: Apprroyed By:
Sign. /
Name | Ms. Sejal Patel S. Usha Patel Mr. Hemant Kulkarni
Designation | Q.C. Executive Q.C. Manager Q.A. Manager _
e

357, G.I.D.C. Sachin Surat — 394 230
Gujarat (India)
A <1000 CFU /g 45 CFU /g 45 CFU /g 50 CFU /g 55 CFU /g 65 CFU /g

Microbial Limit Yeast 8: Fungus <100 CFU /g <10 CFU /g <10 CFU /g <10 CFU/g <10 CFU
/g <10 CFU /g
16 Test Escherichia coli Should be Absent /g Absent /g Absent/g Absent /g Absent /g
Absent/g
Salmonella Should be Absent /10 g Absent 10 g Absent 10 g Absent 10 g Absent /10 g
Absent 10 g
P. aureginosa Should be Absent /g Absent /g Absent /g Absent /g Absent /g Absent/g
S. aureas Should be Absent /g Absent/g Absent/g Absent/g Absent/g Absent /g4
Sign. " o ZN > — Y
Analysis by | Vikas Vikas Vivek Vivek Vikas
Date of Analysis | 01-08-2018 08-09-2018 08-10-2018 08-11-2018 08-02-2019
Remarks: The Product Complies /SDees-net-Cemplies with the laid down Specifications
and Significant- Change / No Significant Change is Observed and No evidence for any
Major Degradation of Accelerated
Stability Study after _06_Months
Prepared By: Checked;By: Approved By: |
Sign. o _ _
Name | Ms. Sejal Patel 4015. Usha Patel Mr. Hemant Kulkarni |
Designation | Q.C. Executive Q.C. Manager Q.A. Manager _ |
G Globela Pharma Pvt. Ltd.
QUALITY CONTROL DEPARTMENT

REAL TIME STABILITY STUDY SUMMARY REPORT
Giobels Phama £É Gujarat (India)

! Product Abiraterone Acetate Tablet USP 250 mg | BatchNo — | PDO18807 | Batch Size
|_10,000 Tablets
Packaging Primary packing Bottle pack of 120 Tablets Date of manufacturing —07/2018
Procedure Secondary packing _| One bottle is packed in one printed carton Date of
Expiry =— — 06/2020
| Storage The Simulated Market Packs are kept in Humidity Chamber at 30%C +2*C
Temperature and 65% +5% Relative Date of Conmencement of Study L 01/08/2018
Condition Humidity for_24 Months Date of Completion of Study — 08-08-2020
Reason Ne Stability Study ( 1) Product manufactured first time 2) Formulation
Change 3) Packing materials change, 4) Regulatory requirements 5) Process change6)
Equipments change
SN - Test Specification (s) 3 Initial 03 Month 06 Month O9 Month | — 12Month
Due date > 25-07-2018 01-11-2018 01-02-2019 01-05-2019 01-08-2019
1 Description de more DANCE CCE CE SES ETO Complies Complies Complies Complies
Complies
—_ The retention time of the major peak of the Sample _ e. _
A solution corresponds to that of the Standard solution, as Complies Complies
2 Identification | obtained in the Assay.
| The UV spectrum of the major peak of the Sample solution
B corresponds to that of the Standard solution, as obtained Complies Complies
in the Assay. E.
3 -_ Weight of 20 tablets 14.3000 gm +5% 14.3521 gm 14.3625 gm 14.4261 gm 14.4210
gm 14.4052 gm
4 Average Weight of tablet 0.7150 gm +5% 0.7176 gm 0.7181 gm 0.7213 gm 0.7210 gm
0.7202 gm
. N . Not more than 2 tablets of 20 tablet sample should . ; .
5 Uniformity of weight deviated from the avg.wt.by more than 5 % Complies Complies
6 Disintegration Time Not more than 15 minutes 5min11sec 5ming1sec 6 min 11 sec 6
min 47 sec 7 min 07 sec
7 Length 16.0 mm +0.2mm 18.15 mm 16.10 mm 16.00 mm | 16.02 mm 16.06 mm
8 Breadth 95 mm + 0.2mm 9.52mm 9.52 mm 9.55 mm 9.58 mm 956 mm
9 Thickness -6.0 + 0.3 mm 6.28 mm 6.00 mm 6.04 mm 6.04 mm 6.06 mm
10 | Hardness Not less than 3.0 kg / cm? 3.0 kg/em? 3.5 Kg/em* 3.5 Kg/em* 4.0
Kg/em* 4.0 Kg/em-
11 Friability Not more than 1.0% 0.22 % 0.25% 0.28 % 0.27 % 0.30 %
| ; ; NLT 85% (Q)) of the labeled amount of Abiraterone acetate 9 9 N A a
12 | Dissolution test CmHasNO») is dissolved in 45 Min. 90.35% 90.15% 89.85% 89.85%
89.35%
7-Ketoabiraterone acetate | Not more than 0.50% 0.08% 0.07% 0.09% 0.17% 0.22%
a Epoxyabiraterone acetate | — Not more than 0.80% 0.04% 0.05% 0.07% 0.09% 0.13%
0.19%
Impurity Abiraterone —Q e — | — Notmorethan0.40% 0.09% 0.10% 0.13% 0.17% — | 018% —
_
| Total Impurity Not more than 2.00% 0.35% 0.38% 0.49% 0.69% 0.83%
Uniformity of dosage unit " o
3.84% 4.08% 4.49% 4.81%
14 (By Uniformity of Content) Acceptance value (AV) should be not more than 15%
3.15% o o o o
Assay: Each uncoated tablet contains: Abiraterone Acetate Tablets contain NLT 90.0%
and NMT
15 | Abiraterone Acetate USP....250 mg 110.0% of the labeled amount of Abiraterone
acetate 101.5% 101.2% 100.8% 100.4% 99.9%
(CasHasNO2). |
Microbial Limit Aerobic Mesophiles <10* CFU /g 45 CFU /g 50 CFU /g 55 CFU /g 55 CFU
/g 65 CFU /g
161 Test Yeast 8 Fungus —<10? CFU/g <10 CFU/g <10 CFU /g <10 CFU /g <10 CFU /g <10
CFU /g
Escherichia coli Should be Absent/g Absent /g Absent /g Absent /g Absent /g
Absent /g
Prepared By: | Checked By: Approved By:
Sign. y
Name | Ms. Sejal Patel . USha Patel Mr. Hemant Kulkarni
Designation | Q.C. Executive Q.C. Manager Q.A. Manager
[€

357, G.1.D.C. Sachin Surat — 394 230

Gtobeia Pharma 5. Gujarat (India)

Salmonella Should be Absent / 10 g Absent 10 g Absent /10 g Absent /10 g Absent 10
g Absent 10 g
P. aureginosa Should be Absent /g Absent /g Absent /g Absent /g | Absent /g
Absent /g
S. aureas Should be Absent /g Absent /g. Absent /g Absent /g Absent /g — Absent /g
o —. _ Sign. — —]
—_ o Analysis by Vikas Vikas Vivek Vivek Vivek |
— e Date of Analysis 01-08-2018 08-11-2018 08-02-2019 08-05-2019 08-08-2019 —__
Prepared By: Checked By: _ Approved By:
Sign. Al y
Name | Ms. Sejal Patel 7Usha Patel — | Mr. Hemant Kulkarni
Designation — Q.C. Executive Q.C. Manager Q.A. Manager
Globela Pharma P Guijarat (India) |

Product Abiraterone Acetate Tablet USP 250 mg | Batch No Batch Size 10,000 Tablets
Packaging Primary packing Bottle pack of 120 Tablets Date of manufacturing |
07/2018
Procedure Secondary packing One bottle is packed in one printed carton Date of
Expiry | 06/2020
| Storage The Simulated Market Packs are keptin Humidity Chamber at 30%C +2*C
Temperature and 65% +5% Relative | Date of Commencement of Study | 01/08/2018
Condition Humidity for 24 Months | Date of Completion of Study 08-08-2020
Reason for Stability Study (

Tick on y )
1) Product manufactured first time 2) Formulation Change 3) Packing materials

change, 4) Regulatory requirements 5) Process change6) Equipments change
Specification (s) % 18 Month a 24 Month

EL CEL Due date > 01-02-2020 01-08-2020
1 Description White colored oval shaped uncoated Tablet, having both side plain.
Complies Complies
| The retention time of the major peak of the Sample solution corresponds to that
of the . .
> | Identification NO Standard solution, as obtained in the Assay. " Complies —
Complies
The UV spectrum of the major peak of the Sample solution corresponds to that of the
. .
E Standard solution, as obtained in the Assay. Complies Complies
3 Weight of 20 tablets 14.3000 gm +5% 14.3250 gm 14.3850 gm
4 Average Weight of tablet 0.7150 gm +5% 0.7162 gm 0.7192 gm
5 Uniformity of weight . more than 2 tablets of 20 tablet sample should deviated
from the avg.wt.by more than Complies Complies
6_ | Disintegration Time | Not more than 15 minutes — 8min23sec 9 min 47 sec
7 Length 16.0 mm +0.2 mm 16.04 mm 16.00 mm
8 Breadth 9.5 mm + 0.2mm 9.52 mm 9.82 mm
9 Thickness 6.0 + 0.3 mm 6.08 mm 6.02 mm
10 | Hardness Not less than 3.0 kg / em? 4.5 Kg/em 4.5 Kg/em-
11 | Friability Not more than 1.0% 0.33 % 0.35%
NLT 85% of the labeled amount of Abiraterone acetate (C2sH3NO2) is dissolved in 45
12 | Dissolution test Mm (q) mou Ol Ao Taeron (Cash=NO+) is dissolved in 89.00%
88.75%
7-Ketoabiraterone acetate Not more than 0.50% 0.28% 0.30%
a Epoxyabiraterone acetate Not more than 0.80% 0.17% 0.19%
13 | Organic _B Epoxyabiraterone acetate Not more than 0.80% 0.21% 0.26%
Impurity Abiraterone Not more than 0.40% 0.19% 0.21%
Unspecified impurity Not more than 0.20% 0.13% 0.18%
| Total Impurity Not more than 2.00% 0.98% — 1.14%
14 | Uniformity of dosage unit (By Uniformity of Content ) Acceptance value (AV)
should be not more than 15% _ o N — 4.85% 5.17%
15 Assay: Each uncoated tablet contains: Abiraterone Acetate Tablets contain NLT
90.0% and NMT 110.0% of the labeled amount of 99.5% 99.0%
Abiraterone Acetate USP....250 mg Abiraterone acetate (CasHasNO>). MA —
Aerobic Mesophiles <10%* CFU/g 70 CFU /g 75 CFU /g
. o Yeast 8. Fungus <10*? CFU /g <10CFU/g <10 CFU /g
16 MicrobialEimitiTest Escherichia coli Should be Absent/g Absent /g Absent/g
Salmonella — | Shouldbe Absent/10g — _ — Absent/10g Absent 10 g
_P. aureginosa Should be Absent /q Absent /g Absent/g
—| S. aureas Should be Absent /g _ _ Absent /q Ne Absent /9
——— Sign. — —e
— — Analysis by Vikas Vikas
Prepared By: Checked By: Approved By: —_ “- "
L Sign. | AM Wi _ - —-
Name | MS. Sejal Patel “ USha Patel Mr. Hemant Kulkarni
_.—
%
pa
y
Globela Pharma


Gujarat (India)
Date of Analysis | 08-02-2020 | — 08-08-2020
Remarks: The Product Complies /Dees-net-Cemgplies with the laid down Specifications
and Significant- Change / No Significant Change is Observed and No evidence for any
Major
Degradation of real time Stability Study after __24_ Months
[ _ Prepared By: Checked By: Approved By: —
| Sign. = Y
| Name | MS. Sejal Patel sha Patel Mr. Hemant Kulkarni

| Designation | Q.C. Executive Q.C. Manager Q.A. Manager
357, G.1.D.C. Sachin Surat — 394 230
Globela Pharma Put. Ltd. | Gujarat (India)
QUALITY CONTROL DEPARTMENT |

REAL TIME STABILITY STUDY SUMMARY REPORT |
Product Abiraterone Acetate Tablet USP 250 mg | BatchNo | PDO18808 Batch Size |
10,000 Tablets
Packaging Primary packing Bottle pack of 120 Tablets Date of manufacturing 07/2018
Expiry 06/2020
Temperature and 65% +5% | Date of Commencementof Study —| 01/08/2018
Condition Relative Humidity for 24 Months Date of Completion of Study — | 08-08-
2020
Reason for Stability Study | 1) Product manufactured first time 2) Formulation

Equipments
( Tick on y ) change

Due date > 25-07-2018 01-11-2018 01-02-2019 01-05-2019 01-08-2019
e White colored oval shaped uncoated Tablet, having Complies Complies Complies
Complies Complies
1 Description - -
both side plain.
The retention time of the major peak of the Sample Complies Complies Complies
Complies Complies
A solution corresponds to that of the Standard solution,
2 Identification as obtained in the Assay.
The UV spectrum of the major peak of the Sample Complies Complies Complies Complies
Complies
B solution corresponds to that of the Standard solution,
as obtained in the Assay. |
3 Weight of 20 tablets 14.3000 gm + 5% 14.4025 gm 14.3852 gm 14.3785 gm 14.3654 gm
14.3845 9m
4 Average Weight of tablet 0.7150 gm +5% 0.7201 gm 0.7192 gm 0.7189 gm 0.7182 gm |
0.7192 gm
E. . Not more than 2 tablets of 20 tablet sample should | Complies Complies
D De es deviated from the avg.wt.by more than 5 %
6 Disintegration Time Not more than 15 minutes 5 min 25 sec | 5 min 05sec 5 min 47
7 Length - 16.0 mm +0.2mm 16.06 mm 16.12 mm 16.04 mm 16.00 mm 16.00 mm
8 Breadth 95 mm + 0.2mm 9.52 mm 9.565 mm 9.50 mm 9.588 mm 9.54 mm
9 Thickness 6.0 + 0.3 mm 6.18 mm 6.02 mm 6.00 mm 6.02 mm 6.16 mm
10 Hardness Not less than 3.0 Kg/em2 3.0 kg/em? 3.5 Kg/em? 3.5 Kg/em? 3.5 Kg/em?
4.0 Kg/em?
11 Friability Not more than 1.0% 0.21% 0.27% 0.26% 0.29% 0.31 %
. . NLT 85% (Q) of the labeled amount of Abiraterone o o A A A
12 Dissolution test acetate (C26Hs:NO>) is dissolved in 45 Min. 91.90% 89.85%
89.55% 89.30% 89.00%
7-Ketoabiraterone acetate _| Not more than 0.50% 0.03% 0.06% 0.07% 0.09% 0.16%
H [o] o, 0, O, O,
E Not more than 0.80% 0.02% 0.05% 0.06% 0.08% 0.09%
1 i 0, O, o, o, 0,
13 Organic B Epoxyabiraterone Not more than 0.80% 0.06% 0.08% 0.09% 0.11% 0.16%
Impurity acetate " —]
Abiraterone Not more than 0.40% 0.07% 0.09% 0.14% 0.16% 0.18%
— _ Total Impurity Not more than 2.00% 0.24 % 0.36% 0.45% 0.54% N 0.70%
Uniformity of dosage unit
2.49% 3.69% 4.09% 4.16% 4.28%
Prepared By: Checked By: Approved By: o
Sign. a Z7 E
Name | Ms. Sejal Patel Mrs. UShY del Mr. Hemant Kulkarni
G uoPela hanna Pvc 394 230 QUALITY CONTROL DEPARTMENT |
- ma: REAL TIME STABILITY STUDY SUMMARY REPORT |
Globela Pharma Pve. Ltd, | Gujarat (India)
Assay: Each uncoated tablet | Abiraterone Acetate Tablets contain NLT 90.0% and
100.2% 100.6% 100.4% 100.0% 99.7% |
15 contains: NMT 110.0% of the labeled amount of Abiraterone
Abiraterone Acetate USP....250 mg _ | acetate (C26H33NO>). |
Aerobic Mesophiles <10% CFU /g 45 CFU/g 50 CFU/g 55 CFU /g 55 CFU /g 65 CFU/g |
. . Yeast é Fungus <10? CFU /g <10 CFU /g <10 CFU /g <10 CFU /g <10 CFU /g <10
CFU /g
16 Microbial Escherichia coli Should be Absent /g Absent Absent Absent Absent —
Absent
Limit Test Salmonella Should be Absent/ 10 g Absent Absent Absent Absent Absent
P. aureginosa Should be Absent /g Absent Absent Absent Absent Absent
S. aureas Should be Absent /g Absent Absent Absent Absent Absent
Sign. | 1— LE? GA 7 7
Analysis by Vikas Vikas Vivek Vivek Vivek
Date of Analysis | 01-08-2018 08-11-2018 08-02-2019 08-05-2019 — 08-08-2019 —
Sign. "”,
Name | MS. Sejal Patel MrsUsña Patel Mr. Hemant Kulkarni
(€
Gtobala Pharma Put. Li

357, G.1.D.C. Sachin Surat — 394 230
Gujarat (India)

Product Abiraterone Acetate Tablet USP 250 mg Batch No | PDO18808 | Batch Size |
10,000 Tablets
Packaging Primary packing Bottle pack of 120 Tablets Date of manufacturing 07/2018
Expiry 06/2020
Temperature and 65% +5% Relative Date of Commencement of Study 01/08/2018
Condition Humidity for 24 Months Date of Completion of Study 08-08-2020
Reason for Stability Study

(Tick on y )
1) Product manufactured first time 2) Formulation Change 3) Packing materials

change, 4) Regulatory requirements 5) Process change6) Equipments change
N Specification (s) á 18 Month 24 Month

S Test Due date > 01-02-2020 01-08-2020
Y
1 Description White colored oval shaped uncoated Tablet, having both side plain.
Complies Complies
A The retention time of the major peak of the Sample solution corresponds to that
of the Complies Complies
2 Identification Standard solution, as obtained in the Assay.
B The UV spectrum of the major peak of the Sample solution corresponds to that of
the Complies Complies
Standard solution, as obtained in the Assay.
3 Weight of 20 tablets 14.3000 gm +5% 14.3852 gm 14.35719m__|
4 Average Weight of tablet 0.7150 gm + 5% 0.7192 gm Oo
5 Uniformity of weight Not more than 2 tablets of 20 tablet sample should deviated
from the avg.wt.by more than 5 % Complies Complies
6 | Disintegration Time at 37” C Not more than 15 minutes in Water =— 8 min 24 sec
9 min 47 sec
7 Length 16.0 mm +0.2 mm 16.02 mm 16.00 mm
9 Thickness 6.0 + 0.3 mm 6.12 mm 6.40mm
10 Hardness Not less than 3.0 Kg/em? 4.5 Kg/em* 4.5 Kg/em-
11 | Friability Not more than 1.0% 0.35% 0.36%
12 Dissolution test NLT 85% (Q) of the labeled amount of Abiraterone acetate
(C2sHssNO2) is dissolved in 45 Min. 88.70% 88.20%
7-Ketoabiraterone acetate Not more than 0.50% 0.18% _0.19%
13 Organic B Epoxyabiraterone acetate Not more than 0.80% 0.18% 0.20%
Impurity Abiraterone Not more than 0.40% 0.14% 0.16%
Total Impurity Not more than 2.00% 0.69% 0.77%
Uniformity of dosage unit o 4.57% 5.30%
14 (By Uniformity of Content ) Acceptance value (AV) should be not more than15%
- H - 0, 0,
Aa Eon ED conan Abiraterone Acetate Tablets contain NLT 90.0% and NMT 110.0% of the
labeled amount of SE Do
15 Abiraterone Acetate USP....250 mg .
Abiraterone acetate (C2sHssNO2).
Aerobic Mesophiles <10% CFU /g 70 CFU/g 75 CFU /g
a Yeast 8 Fungus <10* CFU /g <10 CFU /g <10 CFU 1g
ue ICroD a Eme Escherichia coli Should be Absent/g Absent Absent
Salmonella Should be Absent/ 10 g Absent L Absent
P. aureginosa Should be Absent/g Absent Absent

Sign. 7
Name | Ms. Sejal Patel (%. Usha Patel Mr. Hemant Kulkarni
(€
Globela Pharma

Gujarat (India)

| S. aureas
—_— |
| Should be Absent /g Absent Absent ,

| Sign. [A _—£
Analysis by Vikas Vikas -
——
Date of Analysis |
08-02-2020
08-08-2020
|
Remarks: The Product Complies /Dees-net-Complies with the laid down Specifications
and Sigrifieant-Change / No Significant Change is Observed and No evidence for any
Major
Degradation of real time Stability Study after
— 24 Months
Prepared By: | Checked By: Approved By:

Name S. Sejal Patel | - Usha Patel Mr.
Designation — Q.C. Executive [a.c. Manager " Q.A. Manager
mant Kulkarni
| ( A
Y
y
Globela Pharma Pvt. Ltd. QUALITY CONTROL DEPARTMENT

257, G1.D.C. Sachin Surat - 394230 | REAL TIME STABILITY STUDY SUMMARY REPORT
Globela Pharma Gujarat (India)

Product Abiraterone Acetate Tablet USP 250 mg | Batch No | PDO18809 Batch Size |
10,000 Tablets
Packaging Primary packing Bottle pack of 120 Tablets Date of manufacturing 072018
Expiry o —06:2020
Temperature and 65% +5% Relative | Date of Commencement of Study 01/08/2018
Condition Humidity for 24 Months Date of Completion of Study | 08-08-2020
Reason - Stability Study ( 1) Product manufactured first time 2) Formulation Change
Equipments change
| a - - o" - Specification (s) 8 _ Initial 03 Month 06 Month | 09 Month 12 Month
| Due date > 25-07-2018 01-11-2018 01-02-2019 01-05-2019 01-08-2019
Mm White cWlored oval shaped uncoated Tablet, having ; ; . . ;
1 Description both side plain. Complies Complies Complies Complies Complies
The retention time of the major peak of the Sample |
A solution corresponds to that of the Standard solution, Complies Complies Complies
Complies Complies
2 Identification as obtained in the Assay. _ — —
The UV spectrum of the major peak of the Sample
B solution corresponds to that of the Standard solution, Complies Complies |
as obtained in the Assay. | |
3 Weight of 20 tablets — 14.3000 gm +5% 14.3850 gm 14.3985 gm 14.4052 gm — 14.3985
gm 14.4052 gm
4 Average Weight of tablet 0.7150 gm +5% 0.719 gn O0719g98m | 07202g9gm | 071999m
0.7202 gm
. - . Not more than 2 tablets of 20 tablet sample should . . . . .
5 Uniformity of weight deviated from the avg.wt.by more than 5 % Complies Complies
6 | Disintegration time Not more than 15 minutes 5 min 21 sec 5 min 45 sec 6 min 17
7 Length 16.0 mm _+0.2mm 16.16 mm 16.02 mm 16.00 mm 16.02 mm 16.02 mm
8 Breadth 9.5 mm + 0.2mm 9.52 mm 9.52 mm 9.52 mm 9.50 mm 9.58 mm
9 Thickness 6.0 + 0.3 mm 6.08 mm 6.04 mm 6.02 mm — 6.04MM 6.06 mm |
10 Hardness Notless than 3.0 Kg/em? 3.0 kg/cm? 3.5 Kg/em? 3.5 Kg/em* 4.0 Kg/em” 4.5
Ka/em-
11 Friability Not more than 1.0% 0.27 % 0.26 % 0.29 % 0.30% 0.31%
; ; NLT 85% (Q) of the labeled amount of Abiraterone o ' | E. o No AmO
12 Dissolution test acetate (CasHzNO2) is dissolved in 45 Min. 92.65% 90.90% 90.55%
89.95% 89.65%
7-Ketoabiraterone acetate | Not more than 0.50% 0.05% 0.06% 0.07% 0.09% 0.16%
E Not more than 0.80% 0.02% 0.05% 0.06% 0.08% 0.09%
13 | Organic Impurity E Na Not more than 0.80% 0.07% 0.08% 0.09% 0.11% 0.16%
Abiraterone Not more than 0.40% 0.08% 0.09% 0.14% 0.16% 0.18%
Unspecified impurity | Not more than 0.20% 0.06% 0.08% 0.09% 0.10% 0.11% —
Total Impurity | Not more than 2.00% 0.28% 0.35% 0.45% — | 0.54% 0.70%
Unifornity of dosage unit (By Uniformity of
14 Content y E (By a Acceptance value (AV) should be not more than 5% Complies
Assay: Each uncoated tablet contains: Abiraterone Acetate Tablets contain NLT 90.0%
and |
Ñ : o ;
15 Abiraterone Acetate USP....250 mg NMT 110.0% of the labeled amount of
Abiraterone 100.9% 100.4% 100.0% 99.7% 99.3%
acetate (CasHssNO>).
Aerobic Mesophiles | <10% CFU /g 45 CFU/g 50 CFU /g L 55 CFU /g 55 CFU /g 65 CFU /g
. MU Yeast 6 Fungus <10? CFU/g <10 CFU /a <10 CFU /g <10 CFU /g <10 CFU /g <10
CFU /g
lo Microbial Limit Test Escherichia coli Should be Absent /g Absent /g Absent /g
Absent /g Absent /g — Absent/g
Salmonella Should be Absent / 10 g Absent/ 10 g Absent / 10 g Absent/ 10 g Absent/
10 g Absent / 10 q
Prepared By: _Checked By: Approved By: — —
Sign. A /
Name | Ms. Sejal Patel rs. Usha Patel Mr. Hemant Kulkarni _
Globela Pharma Pue, Ld

Gujarat (India)
| P. aureginosa _ Should be Absent/g Absent /g _Absent /g Absent /g Absent /g

Absent /g
S. aureas - Should be Absent/g _ Absent /g Absent/a_. Absent /g Absent /g Absent
/g_
T Sign. As — Un (E
oa | Analysis by Vikas Vikas Vivek Vivek Vivek
Date of Analysis 01-08-2018 08-11-2018 08-02-2019 08-05-2019 08-08-2019
Prepared By: Checked/By: Approved By:

Sign. 7
Name | Ms. Sejal Patel Mrs. Usha Patel Mr. Hemant Kulkarni
Designation — Q.C. Executive Q.C. Manager Q.A. Manager
Go
Giobela Pharma Pur. Lol

Gujarat (India)

10,000 Tablets
Packaging Primary packing _ Bottle pack of 120 Tablets Date of manufacturing
07/2018
Procedure | Secondary packing) One bottle is packed in one printed carton Date of
Expiry 062021)
Storage | The Simulated Market Packs are kept in Humidity Chamber at 30*%C +2*C
Temperature and 65% +5% Date of Commencement of Study 01/08/2018
Condition Relative Humidity for 24 Months Date of Completion of Study 08-08-2020
Reason for Stability Study | 1) Product manufactured first time 2) Formulation

Equipments
( Tick on y ) change
SN Test Specification (s) 8: 18 Month 24 Month
| Due date > 01-02-2020 01-08-2020
1 Description White dblored oval shaped uncoated Tablet, having both side plain.
Complies Complies
The retention time of the major peak of the Sample solution corresponds ; f
2 Identification a to that of the Standard solution, as obtained in the Assay. SEUS
a EUTUTES
The UV spectrum of the major peak of the Sample solution corresponds . -
_ E to that of he Standard solution, e obtained in the Assay. Complies Om — |
3 Weight of 20 tablets 14.3000 gm + 5% 14.3852 gm 14.3985 gm
4 Average Weight of tablet 0.7150 gm +5% 0.7192 gm 0.7199 gm
5 Uniformity of weight A 20 tablet sample should deviated from the Complies
Complies
6 Disintegration Time Not more than 15 minutes 8 min 54 sec 10 min 14 sec
7 Length 16.0 mm +0.2mm _ 16.00 mm | 16.14 mm
9 Thickness 6.0 + 0.3 mm 6.02 mm 6.04 mm
10 Hardness Not less than 3.0 Kg/em* 4.5 Kg/em? 4.5 Kg/em?
11 Friability Not more than 1.0% 0.35% 0.38%
O, . -
> Dissolution test Ne SE labeled amount of Abiraterone acetate (C26HsaNO2) is
89.50% 89.10%
7-Ketoabiraterone acetate Not more than 0.50% 0.18% _— 0.19%
13 Organic Impurity B Epoxyabiraterone acetate Not more than 0.80% 0.18% 0.20%
Abiraterone Not more than 0.40% 0.20% 0.22%
Total Impurity Not more than 2.00% 0.82% 0.97%
14 Uniformity of dosage unit (By Uniformity of Content ) Acceptance value (AV)
should be not more than 5% Complies Complies
15 Assay: Each uncoated tablet contains: Abiraterone Acetate Tablets contain NLT
90.0% and NMT 110.0% of the 98.8% 98.3%
Abiraterone Acetate USP....250 mg labeled amount of Abiraterone acetate
(C26Hs3NO2). - -
Aerobic Mesophiles <10% CFU /g 75 CFU /g 80 CFU /g
16 Microbial Limit Test Yeast 8 Fungus <10? CFU /g <10 CFU /g <10 CFU /g
Escherichia coli Should be Absent /g Absent /g Absent
Salmonella Should be Absent / 10 g Absent /10g Absent
Prepared By: Checked By: Appreged'By:
Sign. y y ZA
Name | Ms. Sejal Patel S. Usha Patel Mr. Hemant Kulkarni
Gujarat (India)
Globela Pharma

P. aureginosa Should be Absent/g Absent /g Absent

S. aureas Should be Absent /g Absent /g Absent
o Sign. -—€ —W
En Analysis by Vikas Vikas
o Date of Analysis 08-02-2020 08-08-2020
Remarks: The Product Complies /Dees-net-Cemplies with the laid down Specifications
and Significant Change / Ne-Significant-Change-is Observed and No evidence for any
Major
Degradation of real time Stability Study after __24_ Months
Prepared By:
Checkod By: Apgroved By:
Sign. Ea
Name | Ms.Sejal Patel
Mrs. Usha Patel
Mr. Hemant Kulkarni
Designation | Q.C. Executive
Q.C. Manager Q.A. Manager

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Globela Pharma Put, Ltd

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT ACCELERATED

QUALITY CONTROL DEPARTMENT ACCELERATED

Gilobel: Pharma Gujarat (India)

Stability Study after _06__ Months

Prepared By: Checked By: Approved By:

Name | Ms. Sejal Patel $ha Patel Mr. Hemant Kulkarni

Globela Pharma Pvt. Ltd.

CNCA ec QUALITY CONTROL DEPARTMENT ACCELERATED

Globela Pharma Pvt. Ltd.

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT ACCELERATED

STABILITY STUDY SUMMARY REPORT

SN Test Specification (s) 6 Initial 01 Month 02 Month 03 Month 06 Month

E <10? CFU 1g 45 CFU /g 45 CFU /g 50 CFU /g 55 CFU /g 65 CFU /g

16 Merobia Limit Escherichia coli | Should be Absent /g Absent /g Absent/g Absent/g

P. aureginosa Should be Absent/g Absent /g Absent/g Absent /g Absent /g Absent /g

S. aureas Should be Absent /g Absent/g Absent/g Absent /g Absent/g__ Absent /

Date of Analysis 01-08-2018 08-09-2018 08-10-2018 08-11-2018 08-02-2019

Stability Study after _06__ Months

No evidence for any Major Degradation of Accelerated

Prepared By: Checked By: raved By:

Giobela Pharma Pyt. Ltd.

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT ACCELERATED

Globela Pharma Pvt. Ltd.

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT ACCELERATED

STABILITY STUDY SUMMARY REPORT

A <1000 CFU /g 45 CFU /g 45 CFU /g 50 CFU /g 55 CFU /g 65 CFU /g

Prepared By: Checked;By: Approved By: |

QUALITY CONTROL DEPARTMENT

Giobels Phama £É Gujarat (India)

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT

Gtobeia Pharma 5. Gujarat (India)

QUALITY CONTROL DEPARTMENT

REAL TIME STABILITY STUDY SUMMARY REPORT

Globela Pharma P Guijarat (India) |

Reason for Stability Study (

1) Product manufactured first time 2) Formulation Change 3) Packing materials

Specification (s) % 18 Month a 24 Month

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT

357, G.I.D.C. Sachin Surat — 394 230

Date of Analysis | 08-02-2020 | — 08-08-2020

[ _ Prepared By: Checked By: Approved By: —

| Name | MS. Sejal Patel sha Patel Mr. Hemant Kulkarni

QUALITY CONTROL DEPARTMENT |

Reason for Stability Study | 1) Product manufactured first time 2) Formulation

SN Test Specification (s) 8 Initial 03 Month 06 Month 09 Month 12 Month

Gtobala Pharma Put. Li

Globela Pharma Pvt. Ltd.

QUALITY CONTROL DEPARTMENT

Reason for Stability Study

1) Product manufactured first time 2) Formulation Change 3) Packing materials

N Specification (s) á 18 Month 24 Month

Prepared By: Checked By: Approved By: