Saxagliptin

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