Product Overview
Norethisterone Base & Acetate API is a synthetic ingredient manufactured in a GMP-compliant facility.
It meets strict standards, including those of BP and USP. The API comes with thorough quality documentation.
This keeps the API consistent, reliable, and set for global formulation development.
Therapeutic Applications
Norethisterone Base & Acetate API is used to create hormonal and progestin-based products.
It is suitable for oral solid dosage form development and combination products.
This synthetic steroid API offers reliable quality and stable performance.
It is especially useful for formulation tasks that require accurate potency and stability, mainly in regulated markets.
Specification Parameters
These parameters define the quality, purity, and compliance standards for Norethisterone Base & Acetate API.
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Chemical Name : Norethisterone Base: 17α-Ethynyl-19-nortestosterone, Norethisterone Acetate: 17α-Ethynyl-17β-hydroxy-19-nortestosterone acetate
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CAS Number: Norethisterone Base: 68-22-4, Norethisterone Acetate: 51-98-9
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Molecular Formula & Weight: Base: C₂₀H₂₆O₂, 298.42 g/mol, Acetate: C₂₂H₂₈O₃, 340.46 g/mol
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Appearance: Base: White to off-white solid, Acetate: White powder/solid
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Assay Method: HPLC (High-Performance Liquid Chromatography) for purity (>99%)
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Related Substances / Impurities: Quantified by HPLC/GC; includes Norethisterone and other known impurities.
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Residual Solvents: Tested and controlled as per ICH Q3C guidelines.
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Elemental Impurities (ICH Q3D): Limits for heavy metals and toxic elements are defined and monitored.
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Loss on Drying / Water Content: Measured to ensure that the moisture content is within specified limits.
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Identification Tests: Confirm identity using UV, IR, and HPLC comparisons with reference standards.
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Solubility: Base: Poorly soluble in water. Acetate: ~0.00542 mg/mL in water
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Microbial Limits: Total aerobic microbial count and absence of pathogens as per pharmacopoeial standards.
Packaging & Storage
To keep Norethisterone Base and Acetate APIs fresh and of high quality, they are kept in strong containers.
The materials used for these containers are fibre, cardboard, and HDPE.
They’re made to be very secure and keep things well sealed.
Keep it in a cool, dry spot, out of direct light and moisture.
Why Choose Us
Actiza Industry provides top-notch Norethisterone Base and Acetate APIs. We closely follow all regulations. This builds trust with pharmaceutical manufacturers globally.
Quality Assurance
We follow WHO-GMP and ISO standards, checking each batch for purity and stability. We also confirm it follows pharmacopeial regulations.
Advanced Facilities
Our factory has top-notch machines and automated systems. We also have areas set aside to prevent cross-contamination. This setup supports efficient and safe API production.
Regulatory Support
We provide complete documentation, including CoA, MSDS, and DMF support. Our APIs follow BP, USP, and ICH guidelines. This makes registration and global market access easier.
Reliable Supply
Actiza Industry keeps production running smoothly and delivers on time. Bulk packaging in drums and secure storage keep our APIs stable. We are dependable for pharmaceutical formulation needs worldwide.
