361442-04-8 Lipid regulating drugs Pharmaceuticals
Product name
Saxagliptin CAS:361442-04-8
Packaging, Storage &Shelf Life
Package
1kg/bag,25kg/ drum
Storage
Stored in original packaging for two years at a temperature not exceeding 40°C.
Shelf life
2 years if sealed and stored properly.
Specification
Test |
Specifications |
Result |
Assay Content % by HPLC |
Min.98% |
99.08% |
Appearance |
white powder |
Complies |
Odor |
Characteristic |
Complies |
PH |
5.0-7.0 |
6.09 |
Clarity of water solution |
Transparent, colorless, none suspended matters |
Complies |
Loss on drying % |
MAX 0.5 |
0.25 |
Ash % |
MAX.0.5 |
0.38 |
Melting point |
+202.0-212.0°C |
Complies |
Specific rotation |
+174.0-+186.0 |
+181.0 |
Hydroquinone |
Negative |
Complies |
Heavy metals PPM |
MAX.10 |
Complies |
As AAS Pb Cd |
<2ppm <1ppm <1ppm |
Complies Complies Complies |
Microbiology Total Plate Count Yeast & Mold E.Coli S. Aureus Salmonella |
<1000cfu/g <100cfu/g Negative Negative Negative |
122 cfu/g 13 cfu/g Complies Complies Complies |
Conclusion |
Conform with specification |
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