D-Leu7-Triptorelin (CAS 321709-37-9) — A Comprehensive Insight into Triptorelin Impurity and Peptide Reference Standard by Pharmaffiliates

 Introduction to D-Leu7-Triptorelin (CAS 321709-37-9)

D-Leu7-Triptorelin (CAS 321709-37-9) is a specialized peptide variant of the luteinizing hormone–releasing hormone (LHRH) analog family. On the Pharmaffiliates website, it is listed under catalogue code PAPEP003537 and is offered as a reference standard for research and analytical use.

This article explores the chemical identity, applications, and relevance of D-Leu7-Triptorelin, as well as how it fits into the broader context of triptorelin derivatives and impurities.

Chemical Identity & Structure

  • CAS Number: 321709-37-9

  • Synonym / Form: D-Leu7-Triptorelin, often supplied as the ditrifluoroacetate salt in analytical standard form

  • Molecular Formula / Weight: The free base has a molecular weight of approximately 1311.47 (C₆₄H₈₂N₁₈O₁₃)

  • Peptide nature: It is a decapeptide analog, differing by having D-leucine at position 7 in its sequence instead of the L-leucine found in standard triptorelin.

Because D-Leu7-Triptorelin is an analog and impurity variant of the main triptorelin molecule, it is used primarily for analytical characterization, impurity profiling, and as a reference standard for quality control.

Role & Use Cases

Analytical & Reference Standard Use

Pharmaffiliates classifies D-Leu7-Triptorelin under their peptide and impurity catalogue. Its primary value lies in its use as a reference and standardization compound in laboratories that analyze or manufacture triptorelin active pharmaceutical ingredients (APIs).

When pharmaceutical companies produce triptorelin or its salts (such as acetate or pamoate), monitoring potential impurities or isomeric variants is crucial. D-Leu7 is one such non-pharmacopeial impurity. Having a pure standard with CAS 321709-37-9 enables laboratories to calibrate analytical methods such as HPLC, mass spectrometry, and peptide mapping to detect and quantify this variant accurately.

Impurity Profiling in Triptorelin Products

Triptorelin is widely used in the treatment of hormone-dependent conditions such as advanced prostate cancer as a GnRH agonist.

Pharmaffiliates offers a range of related impurities and peptide derivatives (including D-Ser4 and D-Tyr5 variants) in their impurity catalogue.

Using D-Leu7-Triptorelin as a standard helps ensure accurate impurity profiling, controlled release formulation testing, stability studies, and regulatory submissions. In GMP or GLP environments, quantifying trace impurities is often a key part of regulatory drug approval dossiers.

Comparison: Standard Triptorelin vs D-Leu7 Variant

FeatureStandard TriptorelinD-Leu7-Triptorelin (CAS 321709-37-9)
Typical CAS (free base)57773-63-4321709-37-9
Biological applicationClinical API (LH / FSH suppression, prostate cancer therapy)Analytical reference standard, impurity quantification
Structural differenceContains L-leucine at position 7Contains D-leucine at position 7
Use in regulatory QAMain API analysis and assaysImpurity profiling, validation of separation and detection methods

While the D-Leu7 form is not designed for therapeutic use, it plays an essential role in ensuring the purity, integrity, and consistency of the main active drug substance.

Regulatory & Quality Considerations

To meet pharmacopeial and regulatory requirements, manufacturers must identify and quantify known impurities in peptide APIs. The presence of stereoisomeric impurities such as D-Leu7-Triptorelin must be tightly controlled. Using certified reference standards allows laboratories to validate separation and quantification methods for such variants.

Pharmaffiliates provides high-purity peptide standards with detailed product data, including purity, catalogue numbers, and related impurity listings.

Regulatory authorities such as the FDA emphasize the importance of detecting and quantifying peptide impurities during the submission and approval processes of peptide-based drugs. Hence, D-Leu7-Triptorelin is a valuable asset in compliance, analytical development, and quality assurance.

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