Description

Tirzepatide D-Phe22 impurity is a high-purity impurity reference standard designed for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide. In this variant, the L-phenylalanine at position 22 is replaced by its D-enantiomer, a racemization-related impurity that can arise during solid-phase peptide synthesis or under stress conditions. 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-Phe22
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-Phe22]Tirzepatide; Racemization (D-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-Phe22 Impurity Reference Standard