Nonoxynol 9
Nonoxynol-9 Manufacturer | Spermicide & Surfactant Headline: Premium Nonoxynol-9 Manufacturer | Spermicide & Surfactant (CAS: 9016-45-9 / 26027-38-3) Sub-headline: USP/EP Grade | High Purity Non-Ionic Surfactant | Contraceptive & Antiseptic Applications Unique Selling Proposition (USP): • Proven Efficacy: The global standard active ingredient for spermicidal lubricants and gels. • Versatile Chemistry: Functions as an effective non-ionic surfactant, wetting agent, and emulsifier in pharmaceutical and cosmetic formulations. • Regulatory Compliance: Manufactured under strict GMP guidelines to meet USP/EP pharmacopeial monographs.
Introduction
Nonoxynol-9 (N-9), CAS No. 9016-45-9, is a non-ionic surfactant belonging to the family of nonoxynols. It is a viscous, colorless to light yellow liquid that is soluble in water, alcohol, and oil.
While widely recognized for its spermicidal properties (immobilizing sperm by disrupting their cell membrane), Nonoxynol-9 is also valued in the pharmaceutical and personal care industries for its excellent wetting, emulsifying, and cleaning capabilities. It serves as a solubilizer for perfumes and essential oils and as an active agent in certain antiseptic formulations.
Category：
Keywords：
surfactant
nonoxynol-9
spermicide
Functions
1.Spermicidal Action (Contraceptive)
• Mechanism: Surfactant action disrupts the lipid bilayer of the sperm cell membrane (acrosome).
• Action: Immobilizes and kills sperm on contact, preventing fertilization. Widely used in spermicidal gels, foams, films, and condom lubricants.
2.Emulsification & Solubilization
• Mechanism: Reduces surface tension between immiscible phases.
• Action: Stabilizes oil-in-water emulsions in creams and lotions. Solubilizes active pharmaceutical ingredients (APIs) and fragrances in aqueous solutions.
3.Antiseptic/Cleaning Properties
• Mechanism: Membrane disruption of microorganisms.
• Action: Used in some topical antiseptic cleaners and shaving creams for its cleansing and mild antimicrobial effects.
Applications
1.Contraceptive Products
• Application: Spermicidal Gels, Foams, Films, and Suppositories.
• Why it works: It is the only FDA-approved spermicide for over-the-counter use in the US, with a long history of efficacy.
2.Personal Care & Cosmetics
• Application: Shaving creams, hair care products, and facial cleansers.
• Why it works: Acts as a foaming agent and emulsifier, providing a smooth texture and effective dirt removal.
3.Pharmaceutical Excipient
• Application: Solubilizing agent for poorly water-soluble drugs.
• Why it works: Increases the bioavailability of certain topicals and oral solutions.
Flow Chart
1.Reaction: Addition of Ethylene Oxide (EO) to Nonylphenol under alkaline catalysis.
2.Polymerization: Controlled reaction to achieve an average chain length of 9 ethylene oxide units (n=9).
3.Neutralization: Neutralizing the catalyst with acid (e.g., Phosphoric acid).
4.Purification: Removal of unreacted Nonylphenol and Polyethylene Glycol (PEG) by-products.
5.Distillation/Stripping: Removing volatile impurities and water.
6.Filtration: Polishing filtration to ensure clarity.
7.Testing: QC analysis for hydroxyl value and cloud point.
8.Packaging: 200kg HDPE Drums or IBC Totes.
Quality Standard of Lactoferrin
Product: Nonoxynol-9 (USP Grade)
CAS: 9016-45-9
| Item | Specification | Result |
| Appearance | Clear, colorless to light yellow liquid | Conforms |
| Identification | IR / UV | Conforms |
| Acid Value | ≤ 0.2 | 0.05 |
| Water (KF) | ≤ 0.5% | 0.1% |
| Polyethylene Glycol | ≤ 1.0% | 0.6% |
| Free Ethylene Oxide | ≤ 1 ppm | < 0.5 ppm |
| Dioxane | ≤ 10 ppm | < 5 ppm |
| Cloud Point (1% in water) | 52°C - 56°C | 54°C |
| Assay (GC) | Meets USP Requirements | Conforms |
Method of Analysis of Lactoferrin
Test Method: GC (Gas Chromatography) / Titration
• Identity: Infrared Absorption (IR) matches standard.
• Cloud Point: A specific characteristic of non-ionic surfactants, indicating the temperature at which the solution becomes cloudy (phase separation), confirming the correct EO chain length.
• Impurities: GC is critical for monitoring Free Ethylene Oxide and 1,4-Dioxane levels to meet safety regulations.
Reference Chromatogram of Lactoferrin Reference Substance
(Description)
The Gas Chromatogram (GC) or GPC (Gel Permeation Chromatography) profile shows a distribution of oligomers centered around n=9. Peaks for unreacted Nonylphenol and low molecular weight PEGs should be minimal.
Stability and Safety
Stability Studies
• Chemical Stability: Stable under normal conditions. Avoid strong oxidizing agents.
• Shelf Life: 24 Months when stored in original sealed containers.
• Storage Condition: Store at room temperature (15-30°C). May solidify at lower temperatures; gentle heating helps re-liquefy without affecting quality.
Safety & Handling (MSDS Summary)
• Classification: Irritant (Eyes/Skin). Environmental Hazard (Aquatic).
• Handling: Wear safety goggles and gloves. Avoid contact with eyes (severe irritation).
• Usage Warning: Frequent use of N-9 can cause vaginal epithelial irritation, which may increase the risk of STI transmission. Product labeling often includes this warning.
• Storage: Keep container tightly closed.
Customer Comments
R&D Manager, Intimate Health Co. (USA)
2026.02.26
★★★★☆
Production Lead, PharmaFilm (India)
2026.02.26
★★★★☆
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FAQ
Is Nonoxynol-9 safe for daily use?
It is FDA-approved for contraception. However, frequent use (multiple times a day) has been linked to tissue irritation. It is recommended for use as directed on final product labels.
Does it protect against STDs?
No. In fact, due to potential irritation, it provides no protection against HIV or other STDs and may theoretically increase risk if irritation occurs. It is solely a contraceptive.
Is it vegan?
Yes, it is a synthetic chemical derived from petroleum-based precursors (phenol/ethylene oxide). No animal ingredients are used.
References
1.Raymond, E.G., et al. (2004). "Contraceptive efficacy of spermicides..." Contraception.
2.United States Pharmacopeia (USP) Monograph: Nonoxynol-9.
3.WHO. "Nonoxynol-9 for protection against heterosexually acquired HIV infection." (Review of safety).
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