Description

Tirzepatide Endo-Leu14 impurity is a high-purity impurity reference standard designed for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide. This insertion impurity contains an additional leucine at position 14 (duplicated residue) in the Tirzepatide sequence, typically resulting from double coupling during solid-phase peptide synthesis. This reference material supports accurate impurity identification, structural confirmation, and quantitative analysis by HPLC and LC-MS in peptide drug development and manufacturing workflows.

Specifications

Parameter	Value
API Category	Tirzepatide Impurity
Appearance	Off-white lyophilized powder
Catalog Number	BF-TZP-Double-Leu14
Package Size	50 mg (custom sizes available upon request)
Purity	≥95% (HPLC)
Salt Form	Sodium salt
CAS Number	N/A
Parent Compound CAS	2023788-19-2 (Tirzepatide)
Molecular Formula	C231H359N49O69
Molecular Weight	4926.69
Solubility	20% ACN in water
Storage Condition	-20±5°C, protect from light and moisture
Synonyms	[Endo-Leu14]Tirzepatide; [Double-Leu14]Tirzepatide; Insertion (double) impurity

Applications

Pharmaceutical impurity profiling and quality control
HPLC and LC-MS/MS method development and validation
Drug substance and drug product release testing
Stability studies and forced degradation analysis
Regulatory submission support (FDA, EMA, ICH guidelines)

Custom sizes and specifications are available upon request. Please use the Request a Quote button for pricing.

For research use only. Not intended for diagnostic or therapeutic use.

Documents

MSDS

COA

Tirzepatide Endo-Leu14 Impurity Reference Standard