Description

Tirzepatide GLN19 deamidation impurity is a high-purity impurity reference standard used for impurity profiling, analytical method development, and quality control of Tirzepatide. Deamidation at glutamine residue 19 is a well-characterized degradation pathway in peptide drug substances that can be monitored by HPLC and LC-MS. This reference standard supports accurate detection and quantification of deamidated species, ensuring product consistency and compliance with regulatory expectations throughout manufacturing and stability programs.

Specifications

Parameter	Value
API Category	Tirzepatide Impurity
Appearance	Off-white lyophilized powder
Catalog Number	BF-Q19
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	GLN19 deamidation 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 GLN19 (Q19) Deamidation Impurity Reference Standard