Tirzepatide 2023788-19-2

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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
Identification	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.

Hot Tags : Tirzepatide Tirzepatide raw material 2023788-19-2 Semaglutide ‌GIPR/GLP-1R agonist TZP

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