Product Name: 甲磺酸达比加群酯

CAS No.: 872728-81-9

Batch No.: 20191119

Report Date: 20191119

Perform Standard: Enterprise Standard

Items

Standards

Description

Off-White to yellow powder

Identification

IR

UV

HPLC

Water

≤0.5%

Sulphate

≤0.02%

Chlorides

≤0.03%

Residue on ignition

≤0.1%

Methanesulfonic acid

12.62%--13.94%

Related substances

DB-IMP3≤0.5%

DB-IMP4≤0.5%

DB-IMP5≤0.15%

DB-IMP11≤0.15%

DB-IMP14≤0.15%

DB-INT4≤0.15%

Max single ≤0.1%

Total impurities≤1.0%

Heavy metals

20ppm

Assay

98.0%-102.0  Calculated on dried basis

Conclusion: The product conforms to the above standards