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Visible foreign body inspection of Qingkailing injection
test record
Illumination: 2000-3000x
Specification: 10ml each
Results: No visible foreign matter was detected among the 20 test products
The standard stipulates: Among the 20 test products (bottles), no obvious visible foreign matter shall be detected (the smoke-like particle column shall not be detected when rotating, and the metal shavings, glass shavings, and fibers with a length or maximum particle size exceeding 2mm shall not be detected.
Conclusion: meet the regulations
Inspection of visible foreign body of Shuanghuanglian for injection (lyophilized)
test record
Illumination: -3000lx
Specification: 600mg each
Results: After 5 test samples (bottles) were dissolved in 10ml sterile water for injection, no visible foreign matter was detected
The standard stipulates: among the 5 test products (bottles), no obvious foreign matter shall be detected
Insoluble particles inspection of Qingkailing injection
test record
Instrument model: GWJ-5 particle detector
Method: photoresist method
Specification: 10ml each
Preparation of test article: Take 4 test articles, combine the contents, and place them in a sampling cup
Pretreatment: Ultrasound for 30 seconds
Let stand: 2 minutes
Table 19-13 Inspection results of insoluble particles of Qingkailing injection
Results: Each 1ml contains 85 particles with an average value of 10um and above, and 8 particles with an average value of 25um and above
Each test container contains 850 particles of 10um and above, and 80 particles of 25um and above
The standard stipulates: For intravenous injection with a labelled volume of less than 100ml, each test container containing particles of 10um and above must not exceed 6,000, and particles of 25um and above must not exceed 600
Conclusion: Meet the regulations
Inspection of insoluble particles of Shuanghuanglian for injection (lyophilized)
test record
Instrument model: GWJ-5 particle detector
Method: photoresist method
Specification: 600mg each
Preparation of test products: Take 4 test products, add 10ml of particle inspection water to dissolve them, carefully combine the dissolved solutions, and place them in the sampling cup
Pretreatment: Ultrasound for 30 seconds
Let stand: 2 minutes
Table 19-14 Inspection results of insoluble particles of Shuanghuanglian for injection (lyophilized)
Results: Each 1ml contains 114 particles with an average value of 10um and above, and 10 particles with an average value of 25um and above
Each test container contains 1140 particles of 10um and above, and 100 particles of 25um and above
The standard stipulates: Sterile powder for intravenous injection, each test product container must contain no more than 6000 particles of 10um and more than 10um, and no more than 600 particles of 25um and more than 25um
Conclusion: Meet the regulations
Inspection of the melting time limit of Baofukang suppository
test record
Instrument model: RBV-4 melting time limit checker
Test product: Take 3 test products and place them at room temperature for 1 hour
Temperature: 37°C
Solvent: water
Result: All 3 test samples melted within 23 minutes
The standard stipulates: all 3 suppositories of fatty base should melt, soften, or have no hard core when touched within 30 minutes.
Conclusion: meet the regulations
Related links: Softening point inspection of dog skin ointment and weight difference inspection of dog skin ointment