The following is the test standard for pharmaceutical desiccant caps:
1. Appearance
According to the quality requirements of plastic products, combined with the actual sample description, in line with the purpose of fully reflecting the quality of the product.
2. Identification
In order to effectively control the quality of the product and strengthen the monitoring of the formula and set the project, we refer to the YBB00172004-2015 method, select the infrared spectrum and density test, the index is consistent with YBB00112002-2015
3. Residue on ignition
The purpose of this test is to control the inorganic impurities in the plastic. We followed the 0.1% standard for YBB00172004-2015 and the 3.0% standard for the cover with sunscreen.
4. Desiccant Moisture Content Desiccant is a highly absorbent material that may absorb water during production. In order to ensure the quality of the product, it is necessary to control the moisture content of the desiccant to ensure the quality of the product before use.
5. Saturating agent saturated moisture absorption rate
The desiccant capacity of the desiccant is an important indicator to check the quality of the desiccant. The saturated moisture absorption rate of different desiccants is different. To achieve the saturation of moisture absorption, it is taken out to constant weight after 8 days.
6. Short-term moisture absorption rate of desiccant
The short-term moisture absorption capacity of desiccant is also an important indicator to examine the quality of desiccant, simulating the hygroscopicity of the product during use.
7. Drop resistance
This product is a combination and should consider the combined performance of the product.
8. Physical and chemical properties of cardboard
According to the requirements of YBB00172004-2015, the physical and chemical indicators of cardboard have been established.
9. Dissolution test
Easy Oxide This item is designed to control the impurities in the water-soluble extract of the product that may affect the safety and effectiveness of the drug. Method YBB00172004-2015, the indicator is still no more than 1.0ml.
Heavy metals To control the total amount of heavy metals, set this item. . The method of the Pharmacopoeia of the People's Republic of China is adopted, and the indicator is one in a million
Non-volatile methods and indicators are fully based on the requirements of YBB00172004-2015.
10. Microbiological limits The method of the Pharmacopoeia of the People's Republic of China shall be adopted and shall comply with the regulations.
11. Abnormal toxicity The method of the Pharmacopoeia of the People's Republic of China is adopted and should comply with the regulations.
没有评论:
发表评论