Semaglutide NEW

Appearance

White or almost white loose powder

White loose powder

Solubility

Freely soluble in water;

Firstly, to add freshly boiled and cooled water to make a clear solution containing 0.15mg of semaglutide in lml.Then, to

adjust the pHof the solution to 5.5 with 0.05M hydrochloric acid and keep for 30  seconds. Finally, to adjust the pH of the solution to 3.0 and keep 30 seconds. The solution should be turbid in the rang of pH 3.0 to 5.5

Conforms

Identification By HPLC

The retention time of the principal peak of the test solution corresponds to 

that of the reference solution, as obtained in the Assay

Conforms

Amino acid contect

Asp:0.9-1.1

Ser:2.7-3.3

Glu:4.5-5.5

Gly:3.6-4.4

His: 0.9-1.1

Arg:1.8-2.2

Thr:1.8-2.2

Ala:2.7-3.3

Aib:0.9-1.1

Tyr:0.9-1.1

Val:1.8-2.2

Lys:0.9-1.1

Ile:0.9-1.1

Leu:1.8-2.2

Phe:1.8-2.2

AEEA:Should be detected

0.9

3.0

5.0

4.0

1.1

2.2

2.0

3.0

1.0

1.0

1.9

1.0

0.9

2.0

.9

Conforms

Molecular lon Mass

4113.58±1.0

Conforms

pH

7.0-9.0

<8.6

Water Content(K. F)

NMT 10.0%

4.8%

Solution clarity and color

Clear and colorless

Conforms

Related substances

(HPLC)

Impurity A: NMT 0.3%

Impurity D: NMT 0.3%

Any individual impurity: NMT0.1%

Total impurities: NMT1.5%

N.D

0.01%

Any individual impurity: 0.05% 

Total impurities:0.15%

Sodium ion

1.5%-4.0%

2.8%

High molecular protein

NMT   0.5%

N.D

Residual solvent

Methylene chloride NMT 600ppm

Acetonitrile NMT 410ppm

Methanol NMT 3000ppm

DMF  NMT  880ppm

Isopropyl ether NMT 5000ppm

Isopropanol NMT 5000ppm

N.D

20ppm

N.D

N.D

N.D

65ppm

Bacterial Endotoxins

NMT   50EU/mg

Conforms

Microbial Limits

TAMC  NMT  200cfu/g

TYMC  NMT  100cfu/g

10cfu/g

20cfu/g

Acid group ions

Trifluoroacetate ion NMT 0.1%

Phosphate ion NMT 0.1%

Chloride ion NMT 0.1%

Acetate ion NMT 0.1%

N.D

N.D

N.D

N.D

Polycyclic Aromatic

Hydrocarbon

Pass Test

Pass Test

Assay

95.0%-105.0%(Calculated with reference to the anhydrous and salt-free substance.)

100.6%

Storage

Preserve in tight containers.Store at a temperature -15ºC to-25ºC

Conclusion:This batch of product complies with Enterprise Standard