AKRIVIS HEALTH CARE PRIVATE LIMITED
An ISO 9001:2015 Certified Company
Torque building, Bio valley AMTZ, Visakhapatnam, Andhra Pradesh-530031, INDIA.
CIN: U74999AP2017PTC106815
STABILITY TESTING
Name of the Product: Aloevera Exosomes Batch Quantity : 1L
Mfg. Date : 24.08.2022
Batch No. : AKR-22H-240A Testing: In House
MFG : Akrivis Health Care Pvt Ltd Testing Date: 24.08.2022 – 21.11.2022
No of Tests : 20 Duration: 90 days
S. No Test Parameter Initial (Control) After 30 days After 60 days After 90 days
1.0 Physicochemical
1.1 Appearance Liquid Liquid Liquid Liquid
(Liq/Sol/Semi-
Solid/Gas/Gel/Cream)
1.2 pH 7.02 7.08 7.14 7.19
1.3 Gelling No Gelling No Gelling No Gelling No Gelling
1.4 Creaming/Phase No Creaming/ No Creaming/ Phase No Creaming/ Phase No Creaming/ Phase
Separation Phase Separation Separation Separation Separation
1.5 Solidification No Solidification No Solidification No Solidification No Solidification
1.6 Sedimentation No Sedimentation No Sedimentation No Sedimentation No Sedimentation
1.7 Evaporation No Evaporation No Evaporation No Evaporation No Evaporation
1.8 Coagulation No Coagulation No Coagulation No Coagulation No Coagulation
1.9 Flocculation / No Flocculation / No Flocculation / No Flocculation / No Flocculation /
Crystallization Crystallization Crystallization Crystallization Crystallization
2.0 Organoleptic
2.1 Color Clear, Translucent Clear, Translucent Clear, Translucent Clear, Translucent
2.2 Odour Odourless Odourless Odourless Odourless
3.0 Packaging
3.1 Product Container Gamma Irradiated NA NA NA
3.2 Leakage No Leakage No Leakage No Leakage No Leakage
3.3 Weight Loss 0% 0% 0% 0%
Prepared by: J Naveen Kumar Reviewed by: Ch Mounica Approved by:
Dr. Vamsi Krishna I
Sign & Date: 17.08.2022 Sign & Date: 17.08.2022 Sign & Date:18.08.2022
AKRIVIS HEALTH CARE PRIVATE LIMITED
An ISO 9001:2015 Certified Company
Torque building, Bio valley AMTZ, Visakhapatnam, Andhra Pradesh-530031, INDIA.
CIN: U74999AP2017PTC106815
STABILITY TESTING
Name of the Product: Aloevera Exosomes Batch Quantity : 1L
Mfg. Date : 24.08.2022
Batch No. : AKR-22H-240A Testing: In House
MFG : Akrivis Health Care Pvt Ltd Testing Date: 24.08.2022 – 21.11.2022
No of Tests : 20 Duration: 90 days
4.0 Temperature Stability:
S.No Temperature Evaluation Observations
Variations Parameters Control 30 days 60 days 90 days Done by
Sample Sample Sample
4.1 Visual Translucent Translucent Translucent Translucent Akrivis
appearance Clear Clear Clear Clear
4.2 Phase Separation Nil Nil Nil Nil Akrivis
4.3 4⁰C Homogeneity Good Good Good Good Akrivis
4.4 pH 7.02 7.08 7.14 7.19 Akrivis
4.5 Solidification Nil Nil Nil Nil Akrivis
4.6 Visual Translucent Translucent Translucent Translucent Akrivis
Room Temp appearance Clear Clear Clear Clear
4.7 22⁰C – 25⁰C Phase Separation Nil Nil Nil Nil Akrivis
4.8 RH 65% Homogeneity Good Good Good Good Akrivis
4.9 pH 7.02 7.10 7.17 7.21 Akrivis
5.0 Solidification Nil Nil Nil Nil Akrivis
5.1 Thermal Stability
S No Temp Evaluation Initial After Incubation Done by
Parameters
5.3 Visual Translucent Translucent Akrivis
Appearance Clear Clear
5.4 Temp Phase Separation Nil Nil Akrivis
5.5 45⁰C / 48hrs Homogeneity Good Good Akrivis
RH 60%
5.6 - 70% pH 7.02 7.18 Akrivis
Solidification Nil Nil Akrivis
Prepared by: J Naveen Kumar Reviewed by: Ch Mounica Approved by:
Dr. Vamsi Krishna I
Sign & Date: 17.08.2022 Sign & Date: 17.08.2022 Sign & Date:18.08.2022
AKRIVIS HEALTH CARE PRIVATE LIMITED
An ISO 9001:2015 Certified Company
Torque building, Bio valley AMTZ, Visakhapatnam, Andhra Pradesh-530031, INDIA.
CIN: U74999AP2017PTC106815
STABILITY TESTING
Name of the Product: Aloevera Exosomes Batch Quantity : 1L
Mfg. Date : 24.08.2022
Batch No. : AKR-22H-240A Testing: In House
MFG : Akrivis Health Care Pvt Ltd Testing Date: 24.08.2022 – 21.11.2022
No of Tests : 20 Duration: 90 days
5.7 Cycle Testing / Freeze Thawing
Freeze Cycle 1
S Temp Evaluation Control Obs at Cycle 1 Obs at Cycle 1 Done by
No Parameters Sample -10⁰C /24hrs 25⁰C /24hrs
5.8 Visual appearance Translucent Translucent Translucent Akrivis
Clear Clear Clear
5.9 Freeze Phase Separation Nil Nil Nil Akrivis
6.0 Cycle 1 Homogeneity Good Good Good Akrivis
6.1 pH 7.02 7.05 7.09 Akrivis
6.2 Solidification Nil Nil Nil Akrivis
Freeze Cycle 2
S Temp Evaluation Control Obs at Cycle 2 Obs at Cycle 2 Done by
No Parameters Sample -10⁰C /24hrs 25⁰C /24hrs
6.3 Visual appearance Translucent Translucent Translucent Akrivis
Clear Clear Clear
6.4 Freeze Phase Separation Nil Nil Nil Akrivis
6.5 Cycle 2 Homogeneity Good Good Good Akrivis
6.6 pH 7.02 7.13 7.16 Akrivis
6.7 Solidification Nil Nil Nil Akrivis
Freeze Cycle 3
S No Temp Evaluation Control Obs at Cycle 3 Obs at Cycle 3 Done by
Parameters Sample -10⁰C /24hrs 25⁰C /24hrs
6.8 Visual appearance Translucent Translucent Translucent Akrivis
Clear Clear Clear
6.9 Freeze Phase Separation Nil Nil Nil Akrivis
7.0 Cycle 3 Homogeneity Good Good Good Akrivis
7.1 pH 7.02 7.19 7.23 Akrivis
7.2 Solidification Nil Nil Nil Akrivis
Prepared by: J Naveen Kumar Reviewed by: Ch Mounica Approved by:
Dr. Vamsi Krishna I
Sign & Date: 17.08.2022 Sign & Date: 17.08.2022 Sign & Date:18.08.2022
