Norethisterone Enanthate (NET-EN) API is manufactured and exported by Amber Lifesciences Pvt. Ltd. to regulated and semi-regulated markets worldwide. Produced in GMP- and ISO-certified facilities, our API meets stringent pharmacopeial standards (USP/EP/BP) and is backed by complete analytical documentation, ensuring consistent quality and reliability for injectable formulations.
Norethisterone Enanthate API – Technical Specifications
- CAS Number: 3836-23-5
- Molecular Formula: C₂₈H₃₈O₃
- Molecular Weight: 422.6 g/mol
- IUPAC Name: [(8R,9S,10R,13S,14S,17R)-17-acetyl-17-ethynyl-13-methyl-2,3,6,7,8,9,10,11,12,14,15,16-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl] heptanoate
- Appearance: White to off-white crystalline powder
- Solubility: Poorly soluble in water; readily dissolves in organic solvents like ethanol and DMSO.
Norethisterone Enanthate API Therapeutic Applications
- Contraception: Widely used in long-acting injectable contraceptives like Noristerat®, protecting for up to 8–12 weeks.
- Hormone Therapy: Prescribed for menstrual disorders, endometriosis, and hormone replacement therapy (HRT) in combination with estrogen.
Norethisterone Enanthate API Pharmacokinetics & Mechanism of Action
Norethisterone Enanthate is a 19-nortestosterone derivative that binds to progesterone receptors, suppressing ovulation and modifying cervical mucus and the endometrium to prevent pregnancy.
- Route of Administration: Intramuscular (IM) injection
- Half-life: Approximately 7–8 days due to slow release from the ester depot
- Metabolism: Hydrolyzed in the liver to active norethisterone
- Excretion: Eliminated via urine (~50%) and feces (~35%)
Norethisterone Enanthate API Manufacturing & Quality Assurance
At Amber Lifesciences, every batch is produced under GMP and ISO-certified standards. Quality control includes:
- HPLC/GC assay & impurity profiling
- Residual solvent testing
- Identity verification via IR/UV spectroscopy
- Microbial limit testing
- Stability studies as per ICH Q1A(R2) for global climatic zones II–IVb
Norethisterone Enanthate API Packaging, Storage & Handling
- Packaging: Double-lined, tamper-evident bags in HDPE/fiber drums
- Revised: Store between 2–8°C in a dry, light-protected environment to maintain stability.
- Handling: Follow cGMP material management and safety protocols
Norethisterone Enanthate API Global Market Reach
We supply Norethisterone Enanthate API to LATAM, MENA, Europe, Africa and Asia-Pacific, supporting pharmaceutical companies in both regulated and semi-regulated markets. Our efficient logistics network ensures timely deliveries under EXW, FOB, or CIF terms.
Why Choose Amber Lifesciences for Norethisterone Enanthate API?
- GMP & ISO-certified manufacturing facilities
- Full pharmacopeial compliance (USP/EP/BP)
- DMF-ready documentation for regulatory submissions
- Consistent batch-to-batch quality
- Global supply capability with flexible MOQ and optimized lead times
Conclusion:
Norethisterone Enanthate API is an essential progestin for long-acting contraception and hormone therapy, valued for its extended-release profile and therapeutic reliability. Partnering with Amber Lifesciences Pvt. Ltd. ensures you receive a pharmacopeia-compliant, globally trusted API supported by expert technical and regulatory assistance.