Description

Tirzepatide D-γ-Glu impurity is a high-purity impurity reference standard designed for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide. This impurity involves an isomeric variation in the glutamic acid linker of the Tirzepatide side chain (e.g., α- vs γ-linkage or D-configuration), which can arise from raw-material impurities or side reactions during side-chain conjugation. 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-D-gamma-Glu
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	C225H348N48O68
Molecular Weight	4813.53
Solubility	20% ACN in water
Storage Condition	-20±5°C, protect from light and moisture
Synonyms	[D-γ-Glu]Tirzepatide; Side-chain linker isomer 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 D-γ-Glu Impurity Reference Standard