Description

Tirzepatide L-isoAsp15 impurity is a high-purity impurity reference standard used for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide, a GLP-1/GIP dual receptor agonist. This product is part of Biofargo's Tirzepatide Impurity Reference Standards portfolio. Isoaspartate formation at position 15 is a well-documented degradation pathway in peptide drugs that may affect structural integrity and analytical characterization. This reference standard enables accurate identification and quantification of isoAsp-related impurities during manufacturing, stability studies, and batch release testing by HPLC and LC-MS.

Specification

Parameter	Value
API Category	Tirzepatide Impurity
Appearance	Off-white lyophilized powder
Catalog Number	BF-Asp15
CAS Number	N/A
Molecular Formula	N/A
Molecular Weight	N/A
Solubility	20% ACN in water
Storage Condition	-20±5°C, protect from light and moisture
Synonyms	L-isoAsp15 variant

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)

Documents

MSDS

COA

Tirzepatide L-isoAsp15 Impurity Reference Standard