Homart Pharmaceuticals Pty.

Ltd
59 Kirby. St. Rydalmere,NSW 2116, Australia Tel : + 61-2-2948-2880 Fax : + 61-2-9648-2886 info@homart.com.au www.homart.com.au
[ Form F28A ]Product Stability Test
Doc No (Fxxx-xx) : F28A-01 Page No : 1 of 1 Issued On: 09/12/2013
Author: CYL Approver: SS Next Review AS required
Revision File: F28A-RV Product Stability test REFERENCE Revision.doc

Table 7 Stability Test Result Table

Bulk Description Omega -3 1000 mg Product Code BT-0199 Batch No 7110 Manufacture Date 30/06/2016

Storage Condition : Room Temperature below 30oC±2oC / Relative Humidity 75 % ± 5 %

Test Name Specification Methode 0 3 6 9 12 18 24 36
Month Months Months Months Months Months Months Months
Physical Testing
Appearance Oblong shaped clear
capsule containing Organoleptic Complies Complies Complies Complies Complies Complies Complies Complies
light yellow oil
Av. Weight 1294,1-1503,9 Analytical 1424.4 mg 1436.1 mg 1451.25 mg 1455.0 mg 144 9.60 mg 1450.20 mg 1461.10 mg 1455.0 mg
mg/capsule balance
Disintegration NMT 30 Minutes Disintegration 10 min 10 min 12 min 12 min 14 min 14min 16 min 17 min
tester
Chemical Testing
Assay Eicosapentaenoic HPLC 205.0 mg/cap 190.0 mg/cap 179.0 mg/cap 180.2 mg/cap 177.4 mg/cap 174.6 mg/cap 180.6 mg/cap 182.4 mg/cap
acid NLT 162.0 mg complies complies complies complies complies complies complies complies
Docosahexaenoic HPLC 119.8 mg/cap 118.0 mg/cap 118.8 mg/cap 117.6 mg/cap 119.2 mg/cap 115.4 mg/cap 116.8 mg/cap 119.8 mg/cap
acid NLT 108.0 mg complies complies complies complies complies complies complies complies
Microbiological Testing
TVA Count < 104 cfu/g BP 2015 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10
Yeast/Mould < 102 cfu /g BP 2015 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10
E.coli Not detected in 1 g BP 2015 ND/g ND/g ND/g ND/g ND/g ND/g ND/g ND/g
Salmonella Not detected in 10 g BP 2015 ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g
Staphylococcus aureus Not detected in 1 g BP 2015 ND/g ND/g ND/g ND/g ND/g ND/g ND/g ND/g
Heavy metal analysis
Mercury ≤ 0.02 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Arsenic ≤ 5 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Lead ≤ 10 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Cadmium ≤ 0.3 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Time Point Review Initial results Results are Results are Results are Results are Results are Results are Results are
are satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory
Reviewer sign /
Completion
 Homart Pharmaceuticals Pty.Ltd
59 Kirby. St. Rydalmere,NSW 2116, Australia Tel : + 61-2-2948-2880 Fax : + 61-2-9648-2886 info@homart.com.au www.homart.com.au
[ Form F28A ]Product Stability Test
Doc No (Fxxx-xx) : F28A-01 Page No : 1 of 1 Issued On: 09/12/2013
Author: CYL Approver: SS Next Review AS required
Revision File: F28A-RV Product Stability test REFERENCE Revision.doc

Table 7 Stability Test Result Table

Bulk Description Omega -3 1000 mg Product Code BT-0199 Batch No 7210 Manufacture Date 20/07/2016

Storage Condition : Room Temperature below 30oC±2oC / Relative Humidity 75 % ± 5 %

Test Name Specification Methode 0 3 6 9 12 18 24 36
Month Months Months Months Months Months Months Months
Physical Testing
Appearance Oblong shaped clear
capsule containing Organoleptic Complies Complies Complies Complies Complies Complies Complies Complies
light yellow oil
Av. Weight 1294,1-1503,9 Analytical 1422.6 mg 1434.2mg 1450.20 mg 1457.0 mg 1442.30 mg 1449.10 mg 1461.0 mg 1455.8 mg
mg/capsule balance
Disintegration NMT 30 Minutes Disintegration 10 min 10 min 10 min 12 min 12 min 14min 16 min 16 min
tester
Chemical Testing
Assay Eicosapentaenoic HPLC 205.0 mg/cap 198.0 mg/cap 190.0 mg/cap 184.0 mg/cap 179.4 mg/cap 182.2 mg/cap 184.4 mg/cap 182.8 mg/cap
acid NLT 162.0 mg complies complies complies complies complies complies complies complies
Docosahexaenoic HPLC 119.6 mg/cap 118.2 mg/cap 117.2 mg/cap 117.4 mg/cap 116.8 mg/cap 114.8 mg/cap 116.0 mg/cap 118.2 mg/cap
acid NLT 108.0 mg complies complies complies complies complies complies complies complies
Microbiological Testing
TVA Count < 104 cfu/g BP 2015 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10
Yeast/Mould < 102 cfu /g BP 2015 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10
E.coli Not detected in 1 g BP 2015 ND/g ND/g ND/g ND/g ND/g ND/g ND/g ND/g
Salmonella Not detected in 10 g BP 2015 ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g ND/10 g
Staphylococcus aureus Not detected in 1 g BP 2015 ND/g ND/g ND/g ND/g ND/g ND/g ND/g ND/g
Heavy metal analysis
Mercury ≤ 0.02 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Arsenic ≤ 5 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Lead ≤ 10 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Cadmium ≤ 0.3 mg/kg E.P 5.0. Sect ND ND ND ND ND ND ND ND
2.4.8
Time Point Review Initial results Results are Results are Results are Results are Results are Results are Results are
are satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory satisfactory
Reviewer sign /
Completion
Date :