99% up by HPLC Tirzepatide 2023788-19-2

Product Information

Product name

Tirzepatide; TZP

CAS No.

2023788-19-2

Molecular Formula

C225H348N48O68

Molecular Weight

4813.45

Quality Standard

99% up by HPLC, DMF

Amino Acid Sequence

Tyr-{Aib}-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Tyr-Ser-Ile-{Aib}-Leu-Asp-Lys-Ile-Ala-GIn-(diacid-C20-gamma-Glu-(AEEA)2-Lys)-Ala-Phe-Val-GIn-Trp-Leu-Ile-Ala-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2

Appearance

White powder

COA

Test Items

Specifications

Results

Appearance

White powder

White powder

Solubility

Freely soluble in water, insoluble in acetonitrile.

Conforms

Color of solution and clarity

The solution should be clear and colorless.

Conforms

Specific optical rotation

-19.0° - -39.0°(Calculated on anhydrous、 ion-free basis)

-32.9°

Identification

HPLC chromatography: The retention time of the major peak of test solution corresponds to that of the reference solution, as obtain under Assay

Conforms

Monoisotopic mass: 4813.45±1 .0  

4813.05

pH

6.0-8.0

7.4

Water

≤10.0%

1.2%

Sodium ion

≤4.0%

1.3%

Ammonium ion

≤0.5%

ND

Phosphate ion

≤0.5%

ND

Trifluoroacetic acid

≤1000ppm

ND

Acetic acid

≤5000ppm

ND

High molecular weight species

≤0.3%

0.1%

Residual solvents

Triethylamine≤ 0.5%

ND

Methanol ≤ 3000ppm

29ppm

Isopropanol ≤ 5000ppm

ND

Acetonitrile ≤ 410ppm

7ppm

Dichloromethane ≤ 600ppm

ND

Methyl tert-butyl ether ≤ 5000ppm

0 ppm

N,N-dimethylformamide ≤ 880ppm

ND

Methanol ≤ 3000ppm

270ppm

Related substances

Maximum single unknown impurity ≤ 0.5%

0.32%

Total impurities ≤ 2.0%

0.51%

Purity ≥ 98.0%

99.5%

Assay

95.0 % - 105.0% (Calculated as the anhydrous, sodium ion-free, ammonium ion-free, phosphate ion-free substance)

101.2%

Peptide content

≥ 85.0%

97%

Bacterial endotoxins

≤ 10EU/mg

<0.5EU/mg

Microbial Limit

Total aerobic microbial count ≤ 1000cfu/g

< 10cfu/g

Total molds and yeasts count ≤ 100cfu/g

< 10cfu/g

Total E.Coli can not be detected

ND

Amino acid ratio

Asp 1.6-2.4

2.2

Tyr 1.6-2.4

1.7

Lys 1.6-2.4

2.4

Ile 2.4-3.6

2.6

Leu 1.6-2.4

2.0

Val 0.8-1.2

0.9

Thr 1.6-2.4

1.9

Phe 1.6-2.4

1.9

Ser 4.0-6.0

5.3

Ala 3.2-4.8

3.9

Gly 3.2-4.8

4.0

Glu 3.2-4.8

4.2

Trp detected

Detected

Pro 3.2-4.8

4.1

Aib 1.6-2.4

1.8

AEEA 1.6-2.4

1.8

Conclusion

It conforms to all the requirements of enterprise.

Usage