Items | Standard | Result |
Characters and Solubility | A white or almost white,crystalline powder .Freely soluble in water and sparingly soluble in methanol | Complies |
Identification | 1.IR | Complies |
2.Chemical reaction | ||
Crystallinity | meets the requirements | pass |
Specific optical rotation | +58°~ +64° | +63° |
Assay | 916~964 ug/mg (on anhydrous acid basis) | 954ug/mg |
Loss on drying | ≤3.0% | 1.50% |
pH | 4.5~6.5 | 5 |
Clarity and color of solution | Clear | Clear |
max0.20(430nm) | 0.07 | |
Foreign matter | NLT 10um:≤6000 | 493 |
NLT 25um:≤600 | 3 | |
Related substance | Any peak :≤1.0% | 0.50% |
Total Peak:≤3.0% | 1.2% | |
Bacterial endotoxin | less than 0.20EU/mg | Complies |
Sterility | sterile | Complies |
Company Name: Qingdao Dacon Trading Co., Ltd
Registered Address:No. 519, Workshop On 5/F, 1 Hancheng Rd., Free Trade Zone, Qingdao, Shandong, China (Mainland)
Legal Representative/CEO: Ms. Shuming Kang
Registration No.: 91370220747213098M
