This standard specifies the limit requirements and determination methods for 20 sensitized dyestuffs in dyestuff products. The standard applies to dyestuff products in various dosage forms, and requires that the content of sensitized dyestuff does not exceed 150 mg/kg. Extraction is carried out with methanol solvent, separation and qualitative by high-performance liquid chromatograph-diode array Detector (HPLC-DAD), and quantification by Peak area external standard method. For uncertain results, further confirmation is required using liquid chromatograph-tandem Mass spectrometry (HPLC-MS/MS) to ensure product safety.
| Status | Active |
|---|---|
| CCS | G55 | ICS | 71.100.01;87.060.10 |
| Release Date | 2018-12-28 00:00:00 | Implementation Date | 2019-11-01 00:00:00 |