GB/T 39651-2020 in English

Technical control requirements

The mass fraction of tricyclazole technical is adjusted from ≥95.0% to precise control, and the chloroform insoluble matter indicator (≤0.3%) is added. The pH range (4.0-7.0) is used to replace the original acidity control, which is more in line with the actual production process requirements.

Wettable powder improvement

The suspension rate has been increased from 70% to 75%, and a new persistent foaming index has been added (foam volume of 1min <60mL), and the wetting time is maintained ≤60s to ensure the effect of field application. The thermal storage stability requirement must be checked every 3 months to ensure stable performance during storage.

Dual-track detection system

Establish a complementary detection scheme of liquid chromatography (arbitration method) and gas chromatography:

• HPLC uses C18 column, acetonitrile-water (25:75) mobile phase, UV detector (250nm)
• GC uses DB-5 capillary column, triphenyl phosphate internal standard, FID detector

Key points of quality control

Note for the detection of chloroform insoluble matter: After reflux extraction, the sample needs to be hot filtered, dried at 110℃ to constant weight, and the relative deviation of parallel determination is ≤20%. When determining the suspension rate, the remaining suspension needs to be ultrasonically treated to ensure complete dissolution.

Corporate response measures

1. Upgrade the drying process to control moisture ≤0.5%, replacing the original drying loss index
2. Establish a pH buffer system to ensure the range of 4.0-7.0 for the original drug and 6.0-8.0 for the wettable powder
3. Add defoaming agent to meet the new requirements for persistent foaming

Testing laboratory configuration

Required equipment: ultrasonic extractor, constant temperature oven, sand core crucible (G3), HPLC (ultraviolet detector), GC (FID detector), it is recommended to add an automatic sampler to improve detection efficiency.