C228H353N49O69,MW 4884.61

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In stock & estimated to ship in 3-7 days by October 14, 2026

Description

Tirzepatide Endo-Ala21 impurity is a high-purity impurity reference standard designed for pharmaceutical quality control, analytical method development, and regulatory compliance testing of Tirzepatide. This insertion impurity contains an additional alanine at position 21 (duplicated residue) in the Tirzepatide sequence, typically resulting from double coupling during solid-phase peptide synthesis. 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-Double-Ala21
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 C228H353N49O69
Molecular Weight 4884.61
Solubility 20% ACN in water
Storage Condition -20±5°C, protect from light and moisture
Synonyms [Endo-Ala21]Tirzepatide; [Double-Ala21]Tirzepatide; Insertion (double) 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

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