Stability Study Results

Stability Study Results 1

Methods (3 batches of solution were tested)

1. Real-time stability

Design: testing atmosphere temperature at around 4C, 20C and 30C

Storage: avoid light, moisture, temperature 4-30C

Test length: the day of starting the experiment, 1st day, 3rd day, 7th day, 15th day, 1st month, 3rd month, 6th month, 1st year

Samples: R1: negative, R2: weak positive, R3: strong positive

Control group: the day of starting the experiment

1.1 Results

Atmosphere temperature at around 4C

Stability Study Results 2

Atmosphere temperature at around 20C

Stability Study Results 3

Atmosphere temperature at around 30C

Stability Study Results 4

2. Stability after unseal the package

Test length: right after unseal the package, 30min after unseal, 60min after unseal, 3hr after unseal, 6hr after unseal, 12hr after unseal, 24hr after unseal

Samples: R1: negative, R2: weak positive, R3: strong positive

Control group: right after unseal the package

Stability Study Results 5

3. High temperature accelerated stability test

Storage atmosphere: 37C incubator

Test length: incubate 1day, 3day, 7day, 15day, 30day

Samples: R1: negative, R2: weak positive, R3: strong positive

Control group: the day of starting the experiment at room temperature

After tested on the day of starting the experiment at room temperature, a portion of the samples were put in the incubator, then tested on the 1st, 3rd, 7th, 15th, 30th day

Stability Study Results 6

4. Stability during transportation

Design: perform imitation study on possible conditions during transportation

Storage condition: incubator at 37C

Test length: incubate 1day, 3day, 7day

Samples: R1: negative, R2: weak positive, R3: strong positive

Control group: the day of starting the experiment at room temperature

4.1 Shaking and falling test

After tested on the day of starting the experiment at room temperature, a portion of the samples were stored in the incubator at 37C, then tested on the 1st, 3rd, 7th day. Before testing, the kit was dropped 1 meter from the ground, repeated 3 times, then the outer and inner packages were observed for damage

Stability Study Results 7

4.2 Stability during transportation (this test same as high temperature accelerated stability test)

Stability Study Results 8

Summary

  1. The length of real-time stability test is one year, the current test went on the 7th day, results were stable
  2. Test period of viability after unsealing the package was 24 hours, the solution was stable within the first three hours of package unsealed and lost activity after 3 hours
  3. The length of 37C accelerated stability test is 30 days, the current test went on the 7th day, results were stable
  4. The length of transportation stability test is 7 days, results were stable
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