Leuprolide Related Compounds & Impurities

Leuprolide is a GnRH super-agonist that suppresses gonadotropins upon sustained administration, used for prostate cancer, endometriosis and central precocious puberty.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Leuprolide reference standards, pharmacopeial and non-pharmacopeial Leuprolide impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Leuprolide-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Leuprolide Acetate
Leuprolide
Leuprolide EP Impurity B
(D-His2)-Leuprolide
L-Leu-leuprolide
D-Ser-leuprolide
D-Ser-Leuprolide Trifluoroacetate
Leuprolide EP Impurity C
Leuprolide Acetate EP Impurity D
Leuprolide EP Impurity E
Leuprolide Acetate EP Impurity F
Leuprorelin EP Impurity G
Leuprolide Acetate EP Impurity H
Leuprolide Impurity 6
L-Leu6,D-Leu7]leuprolide
[D-pro9]Leuprolide
[D-Trp3,L-Leu6] Leuprolide
[D-Det6,L-Leu6]leuprolide
PGlu-His-Trp
[des-Leu7]leuprolide
Glu.1-Leuprolide
[Glu.1,D-ser] Leuprolide
[Glu.1D-His] Leuprolide
Des-PGLU-leuprolide
Leuprolide impurity 2
Leuprolide impurity 3
Leuprolide impurity 4
Leuprolide Mesylate
Des-1,2,3-Leuprolide
D His Leuprolide
[Ser(Ac)]4-Leuprolide,Acetyl Leuprolide
D-[Pyr]1-Leuprolide
5-9-Leuprolide
Des-Pyr-Leuprolide
Leuprolide Acetate Impurity J
Leuprolide Impurity 5
Leuprolide Acetate Impurity I
Leuprolide Acetate EP Impurity G
Leuprolide-d10 Trifluoroacetic Acid Salt
L-Leu6-Leuprolide
5-9-Leuprolide Trifluoroacetate
Leuprolide Impurity 7
Leuprolide Impurity 8
Pyr-His-Trp-OH
(O Acetyl L Ser) Leuprolide
Leuprolide Dimer
Leuprolide EP Impurity B Trifluoroacetate

Metabolites

PGlu-His-Trp-OH

Isotope Labelled Compounds

Leuprolide 13C6
Leuprolide D10 Trifluoroacetic Acid Salt
Leuprolide-D5