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Basic Info

  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Monthly Production Capacity: 10ton/year

    Packaging Information: 25kg/drum; 5kg/bag, 1kg/bag

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

    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

    1. Tirzepatide is the world's first ‌dual GIP/GLP-1 receptor agonist. It exerts its therapeutic effects by simultaneously targeting two key receptors:

    (1) ‌Glucose-dependent insulinotropic polypeptide (GIP) receptor‌: Enhances insulin secretion and suppresses glucagon, improving glycemic control.

    (2) ‌Glucagon-like peptide-1 (GLP-1) receptor‌: Delays gastric emptying, increases satiety, and promotes glucose-dependent insulin release.

    This dual mechanism provides synergistic metabolic benefits, demonstrating superior efficacy compared to single-target agents.

     

    ‌2. Indications of Tirzepatide:

    Tirzepatide is approved for two primary indications:

    (1) ‌Type 2 diabetes‌: Marketed as ‌Mounjaro®‌, clinical trials (SURPASS series) showed HbA1c reductions up to 2.4%, with some patients achieving normoglycemia.

    (2) ‌Obesity‌: Marketed as ‌Zepbound®‌, FDA-approved in 2023 for chronic weight management in adults, with expansion to the Chinese market in 2024. Pivotal trials (SURMOUNT series) reported mean weight loss of 15%-22%, peaking at 24% (72-week regimen).

     

    ‌3. Key Advantages and Clinical Outcomes‌

    Compared to single GLP-1 agonists (e.g., Novo Nordisk's semaglutide), Tirzepatide exhibits:

    (1) ‌Superior weight loss‌: Head-to-head trials demonstrated 5%-7% greater weight reduction at equivalent doses.

    (2) ‌Enhanced glycemic control‌: Greater improvement in insulin resistance, particularly for patients with obesity-complicated diabetes.

    (3) ‌Comparable tolerability‌: Similar incidence of common adverse effects (nausea, diarrhea) with rare severe events.

     

    *Products under the patent are only for R&D use.

     

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