Description

Tirzepatide ILE12NVA (NVA-ILE) impurity is a high-purity impurity reference standard used for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide. This substitution impurity involves an amino acid variation at position 12 and is critical for evaluating sequence fidelity during solid-phase peptide synthesis. This reference standard enables precise identification and quantification of sequence-related impurities by HPLC and LC-MS in manufacturing and quality assessment workflows.

Specifications

Parameter	Specification
API Category	Tirzepatide Impurity
Appearance	Off-white lyophilized powder
Catalog Number	BF-ILE12NVA
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	ILE12 substitution 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)

Documents

MSDS

COA

Tirzepatide ILE12NVA (NVA-ILE) Impurity Reference Standard