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STABILITY TEST  稳定性测试

Product Name  产品名称 SEDY BOOSTER  SEDY 助推器
LOT No.  拍品编号 NFSD22061
Date of manufacture  生产日期 2022.06.01
Expiry date  有效期 2025.05
Product Name SEDY BOOSTER LOT No. NFSD22061 Date of manufacture 2022.06.01 Expiry date 2025.05| Product Name | SEDY BOOSTER | | :--- | :--- | | LOT No. | NFSD22061 | | Date of manufacture | 2022.06.01 | | Expiry date | 2025.05 |
Test condition  测试条件 Test Item  测试项目 Test method  测试方法 Test Protocol  测试协议 Observation Time  观察时间
Initial  初 4 week  4周 8 week  8周 12 week  12周 16 week  16周 20 week  20周 24 week  24周
Date of testing  测试日期 2022.06.27 2022.07.25 2022.08.22 2022.09.19 2022.10.17 2022.11.14 2022.12.12
45 ∘ C 45 ∘ C 45^(@)C45^{\circ} \mathrm{C} Color  颜色 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Odor  气味 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
pH ( 25 ∘ C ) pH 25 ∘ C pH(25^(@)C)\mathrm{pH}\left(25^{\circ} \mathrm{C}\right) pH meter  pH 计 SOP No. J1-IQT-R02 Title: pH test SOP
SOP 编号 J1-IQT-R02 标题：pH 测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Microbes  微生物 Microbiological agar plate test
微生物琼脂平板试验		 SOP No. J1-IQT-R12 Title: Sterility test SOP
SOP 编号 J1-IQT-R12 标题：无菌测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
25 ∘ C 25 ∘ C 25^(@)C25^{\circ} \mathrm{C} Color  颜色 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Odor  气味 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
pH ( 25 ∘ C ) pH 25 ∘ C pH(25^(@)C)\mathrm{pH}\left(25^{\circ} \mathrm{C}\right) pH meter  pH 计 SOP No. J1-IQT-R02 Title: pH test SOP
SOP 编号 J1-IQT-R02 标题：pH 测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Microbes  微生物 Microbiological agar plate test
微生物琼脂平板试验		 SOP No. J1-IQT-R12 Title: Sterility test SOP
SOP 编号 J1-IQT-R12 标题：无菌测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
4 ∘ C 4 ∘ C 4^(@)C4^{\circ} \mathrm{C} Color  颜色 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Odor  气味 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
pH ( 25 ∘ C ) pH 25 ∘ C pH(25^(@)C)\mathrm{pH}\left(25^{\circ} \mathrm{C}\right) pH meter  pH 计 SOP No. J1-IQT-R02 Title: pH test SOP
SOP 编号 J1-IQT-R02 标题：pH 测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Microbes  微生物 Microbiological agar plate test
微生物琼脂平板试验		 SOP No. J1-IQT-R12 Title: Sterility test SOP
SOP 编号 J1-IQT-R12 标题：无菌测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Sunlight  阳光 Color  颜色 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Odor  气味 Visual  视觉 SOP No. J1-IQT-R14 Title: Color, Odor test SOP
SOP 编号 J1-IQT-R14 标题：颜色、气味测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Microbes  微生物 Microbiological agar plate test
微生物琼脂平板试验		 SOP No. J1-IQT-R12 Title: Sterility test SOP
SOP 编号 J1-IQT-R12 标题：无菌测试 SOP		 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过 Pass  通过
Test condition Test Item Test method Test Protocol Observation Time Initial 4 week 8 week 12 week 16 week 20 week 24 week Date of testing 2022.06.27 2022.07.25 2022.08.22 2022.09.19 2022.10.17 2022.11.14 2022.12.12 45^(@)C Color Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass Odor Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass pH(25^(@)C) pH meter SOP No. J1-IQT-R02 Title: pH test SOP Pass Pass Pass Pass Pass Pass Pass Microbes Microbiological agar plate test SOP No. J1-IQT-R12 Title: Sterility test SOP Pass Pass Pass Pass Pass Pass Pass 25^(@)C Color Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass Odor Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass pH(25^(@)C) pH meter SOP No. J1-IQT-R02 Title: pH test SOP Pass Pass Pass Pass Pass Pass Pass Microbes Microbiological agar plate test SOP No. J1-IQT-R12 Title: Sterility test SOP Pass Pass Pass Pass Pass Pass Pass 4^(@)C Color Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass Odor Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass pH(25^(@)C) pH meter SOP No. J1-IQT-R02 Title: pH test SOP Pass Pass Pass Pass Pass Pass Pass Microbes Microbiological agar plate test SOP No. J1-IQT-R12 Title: Sterility test SOP Pass Pass Pass Pass Pass Pass Pass Sunlight Color Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass Odor Visual SOP No. J1-IQT-R14 Title: Color, Odor test SOP Pass Pass Pass Pass Pass Pass Pass Microbes Microbiological agar plate test SOP No. J1-IQT-R12 Title: Sterility test SOP Pass Pass Pass Pass Pass Pass Pass| Test condition | Test Item | Test method | Test Protocol | Observation Time | | | | | | | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | | | | | Initial | 4 week | 8 week | 12 week | 16 week | 20 week | 24 week | | | Date of testing | | | 2022.06.27 | 2022.07.25 | 2022.08.22 | 2022.09.19 | 2022.10.17 | 2022.11.14 | 2022.12.12 | | $45^{\circ} \mathrm{C}$ | Color | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Odor | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | $\mathrm{pH}\left(25^{\circ} \mathrm{C}\right)$ | pH meter | SOP No. J1-IQT-R02 Title: pH test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Microbes | Microbiological agar plate test | SOP No. J1-IQT-R12 Title: Sterility test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | $25^{\circ} \mathrm{C}$ | Color | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Odor | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | $\mathrm{pH}\left(25^{\circ} \mathrm{C}\right)$ | pH meter | SOP No. J1-IQT-R02 Title: pH test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Microbes | Microbiological agar plate test | SOP No. J1-IQT-R12 Title: Sterility test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | $4^{\circ} \mathrm{C}$ | Color | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Odor | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | $\mathrm{pH}\left(25^{\circ} \mathrm{C}\right)$ | pH meter | SOP No. J1-IQT-R02 Title: pH test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Microbes | Microbiological agar plate test | SOP No. J1-IQT-R12 Title: Sterility test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | Sunlight | Color | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Odor | Visual | SOP No. J1-IQT-R14 Title: Color, Odor test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass | | | Microbes | Microbiological agar plate test | SOP No. J1-IQT-R12 Title: Sterility test SOP | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
Test condition: The test sample is contained in the finished product vial container.
测试条件：测试样品装在成品小瓶容器中。
We hereby certify that the product was found stable after 6 months of testing accelerated aging process under various conditions. This product will be stable for 36 months (Shelf Life)
我们特此证明，在各种条件下测试加速老化过程 6 个月后，该产品是稳定的。本产品可稳定保存 36 个月（保质期）