Levonorgestrel

Levonorgestrel Impurities

Levonorgestrel impurities include process-related compounds, synthetic intermediates, and degradation products that may arise during synthesis, formulation, or storage. As a synthetic progestin widely used in hormonal contraceptives and emergency contraception, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Levonorgestrel EP Impurities

We offer pharmacopeial and non-pharmacopeial Levonorgestrel impurity compounds that conform to European Pharmacopoeia (EP) specifications. These standards support method development, impurity profiling, and stability studies. EP traceable compounds are available upon request and are supplied with validated analytical data including HPLC purity, NMR, and MS characterization.

Levonorgestrel Related Compounds

Levonorgestrel belongs to the gonane class of progestins and is the active levo-isomer of a racemic mixture. Related compounds may include stereoisomeric variants, synthetic intermediates, and structurally similar analogs used in combination therapies or as precursors. These compounds are used in forced degradation studies, impurity identification, and toxicological qualification. All entries are supported by comprehensive analytical documentation and meet international regulatory expectations.

Levonorgestrel Impurity Reference Standards

Levonorgestrel impurity reference standards are supplied with validated analytical data including NMR, MS, and HPLC purity. These compounds are used in pharmaceutical R&D, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request. All products are re-tested at regular intervals to ensure consistency and reliability.