Drug Stability Test
The effectiveness and safety of drugs have attracted much attention, and it is also a livelihood issue that the country and the government attach great importance to. The stability of drugs will affect the efficacy and safety. In order to ensure the quality of drugs and storage containers, stability tests should be performed to determine their effective time and storage state. Stability test mainly studies whether the quality of drugs is affected by environmental factors such as temperature, humidity and light, and whether it changes with time and the correlation between them, and studies the degradation curve of drugs, according to which the effective period is presumed to ensure the effectiveness and safety of drugs when used. This article collects the standard information and test methods required for various stability tests for customers' reference.
First, drug stability test criteria
Storage conditions of drugs:
Storage conditions (Note 2)
Long-term experiment
25℃±2℃ / 60%±5%RH or
30℃±2℃ /65%±5% RH
Accelerated test
40℃±2℃ / 75%±5%RH
Middle test (Note 1)
30℃±2℃ / 65%±5%RH
Note 1: If the long-term test condition has been set at 30℃±2℃/65% ±5%RH, there is no middle test; if the long-term storage condition is 25℃±2℃/ 60% ±5%RH, and there is a significant change in the accelerated test, then middle test should be added. And should be assessed against the criteria of "significant change".
Note 2: Sealed impervious containers such as glass ampoules can be exempted from humidity conditions. Unless otherwise determined, all tests shall be carried out in accordance with the stability test plan in the interim test.
The accelerated test data should be available for six months. The minimum duration of the stability test is 12 months for the middle test and the long-term test.
Store in refrigerator:
Storage conditions
Long-term experiment
5℃±3℃
Accelerated test
25℃±2℃ / 60%±5%RH
Stored in freezer:
Storage conditions
Long-term experiment
-20℃±5℃
Accelerated test
5℃±3℃
If the product containing water or solvents that may be subject to solvent loss is packaged in a semi-permeable container, the stability assessment should be conducted under low relative humidity for a long period of time, or an middle test of 12 months, and an accelerated test of 6 months, in order to prove that the drug placed in the semi-permeable container can withstand the low relative humidity environment.
Containing water or solvents
Storage conditions
Long-term experiment
25℃±2℃ / 40%±5%RH or 30℃±2℃ /35%±5% RH
Accelerated test
40℃±2℃;≤25%RH
Middle test (Note 1)
30℃±2℃ / 35%RH±5%RH
Note 1: If the long-term test condition is 30℃±2℃ / 35%±5%RH, there is no middle test.
The calculation of the relative water loss rate at a constant temperature of 40℃ is as follows:
Substituted relative humidity (A)
Control relative humidity (R)
Water loss rate ratio ([1-R]/[1-A])
60%RH
25%RH
1.9
60%RH
40%RH
1.5
65%RH
35%RH
1.9
75%RH
25%RH
3.0
Illustration: For aqueous drugs placed in semi-permeable containers, the water loss rate at 25%RH is three times that of 75%RH.
Second, Drug stability solutions
Common drug stability test criteria
(Source: Food and Drug Administration, Ministry of Health and Welfare)
Item
Storage conditions
Long-term experiment
25°C /60% RH
Accelerated test
40°C /75%RH
Middle test
30°C/65%RH
(1) Wide temperature range test
Item
Storage conditions
Long-term experiment
Low or sub-zero temperature conditions
Accelerated test
Room temperature and humidity or low temperature conditions
(2) Test equipment
1. Constant temperature and humidity test chamber
2. Drug stability test chamber
Thin Film Solar Cell
Thin film solar cell is a kind of solar cell manufactured by thin film technology, which has the advantages of low cost, thin thickness, light weight, flexibility and bendability. It is usually made of semiconductor materials such as copper indium gallium selenide (CIGS), cadmium telluride (CdTe), amorphous silicon, gallium arsenide (GaAs), etc. These materials have high photoelectric conversion efficiency and can generate electricity under low light conditions.
Thin film solar cells can be used in inexpensive glass, plastic, ceramics, graphite, metal sheet and other different materials as substrates to manufacture, forming a film thickness that can generate voltage only a few μm, so the amount of raw materials can be significantly reduced than silicon wafer solar cells under the same light receiving area (thickness can be lower than silicon wafer solar cells more than 90%). At present, the conversion efficiency of up to 13%, thin film solar cells are not only suitable for flat structure, because of its flexibility can also be made into non-plane structure, has a wide range of application prospects, can be combined with buildings or become a part of the building body.
Application of thin film solar cell product:
Translucent solar cell modules: Building Integrated Solar Energy Applications (BIPV)
Application of thin film solar energy: portable folding rechargeable power supply, military, travel
Applications of thin film solar modules: roofing, building integration, remote power supply, defense
Features of thin film solar cells:
1. Less power loss under the same shielding area (good power generation under weak light)
2. The loss of power under the same illumination is less than that of wafer solar cells
3. Better power temperature coefficient
4. Better light transmission
5. High cumulative power generation
6. Only a small amount of silicon is needed
7. There is no internal circuit short circuit problem (the connection has been built in the series battery manufacturing)
8. Thinner than wafer solar cells
9. Material supply is secure
10. Integrated use with building materials (BIPV)
Solar cell thickness comparison:
Crystalline silicon (200 ~ 350μm), amorphous film (0.5μm)
Types of thin film solar cells:
Amorphus Silicon (a-Si), Nanocrystalline Silicon (nc-Si), Microcrystalline Silicon, mc-Si), compound semiconductors II-IV [CdS, CdTe(cadmium telluride), CuInSe2], Dye Sensitized Solar cells, Organic/polymer solar cells, CIGS (Copper indium selenide)... Etc.
Thin-film solar module structure diagram:
Thin film solar module is composed of glass substrate, metal layer, transparent conductive layer, electrical function box, adhesive material, semiconductor layer... And so on.
Reliability test specification for thin film solar cells:
IEC61646(Thin-film solar photoelectric module test standard), CNS15115(thin-film silicon onshore solar photoelectric module design validation and type approval)
Temperature & humidity test chamber of Lab Companion
Temperature & humidity test chamber series, passed the CE certification, offer 34L, 64L, 100L, 180L, 340L, 600L, 1000L, 1500L and other volume models to meet the needs of different customers. In design, they use environment-friendly refrigerant and high-performance refrigeration system, parts and components are used in the international famous brand.
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