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Product Description
Product Name: Posaconazole
CAS No.: 171228-49-2
Description
Batch No. Quantity 5.5kgs
Mfg. Date Mar. 20, 2018 Package As required
Rep. Date Mar. 24, 2018 Exp. Date Mar. 19, 2020
Items Standards Results
Characteristics White to off-white powder White powder
Identification By IR Complies
By HPLC Complies
Specific Rotation -28°~-34° -32°
Water Content ? 2.00% 0.20%
Heavy Metals ? 10ppm Complies
Sulfated Ash ? 0.10% 0.03%
Residual Solvents Ethanol: ?5000ppm 3ppm
Dichloromethan: ?600ppm ND
Tetrahydrofura: ?720ppm ND
Triethylamin: ?100ppm 5ppm
Toluen: ?890ppm ND
N,N-dimethyl formamide: ?880ppm 27ppm
Dimethyl Sulfoxide: ?5000ppm 324ppm
Related Substances Any single impurity: ?0.10% 0.03%
Total Impurities: ?0.50% 0.09%
Assay
(HPLC basis on drying) 98.0%~102.0% 99.98%
Reference Standard In-house Standard
Conclusion The product complied to In-house standard.
Storage Preserve in tight,light-resistant containers in a cool place