Product Description
Nicotine USP is a high-purity Active Pharmaceutical Ingredient (API) used in various pharmaceutical, therapeutic, and research applications. It is a naturally occurring alkaloid extracted from tobacco leaves and refined to meet stringent United States Pharmacopeia (USP) standards. This pharmaceutical-grade Nicotine USP is commonly used in nicotine replacement therapy (NRT) products such as nicotine gums, patches, inhalers, and lozenges.
At Prism Industries Pvt. Ltd., we ensure that our Nicotine USP is manufactured with the highest level of precision, guaranteeing purity, safety, and effectiveness. Our advanced extraction and purification processes result in Nicotine USP with minimal impurities, making it the preferred choice for pharmaceutical manufacturers worldwide.
Identification
Nicotine USP is identified as a clear, colorless to pale yellow liquid or a fine white crystalline powder with a characteristic odor. It is highly potent and requires controlled handling.
- Chemical Name: (S)-3-(1-Methyl-2-pyrrolidinyl) pyridine
- CAS Number: 54-11-5
- Molecular Formula: C₁₀H₁₄N₂
- Molecular Weight: 162.23 g/mol
- Appearance: Clear liquid or white crystalline powder
- Odor: Strong, characteristic tobacco-like odor
Regulatory Documents & Compliance
Prism Industries Pvt. Ltd. is committed to maintaining global regulatory standards for Nicotine USP to ensure safety, quality, and compliance with pharmaceutical guidelines. We provide all essential regulatory documents for our clients, including:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Good Manufacturing Practice (GMP) Certification
- United States Pharmacopeia (USP) Compliance
- European Pharmacopoeia (EP) Compliance
- Drug Master File (DMF) Submission Available
- REACH Compliance (EU Market Access)
- FDA Registration and Approval
Our Nicotine USP is manufactured following ISO 9001:2015 and GMP-certified standards, ensuring consistency in quality and safety for pharmaceutical applications.
Specifications of Nicotine USP
Prism Industries Pvt. Ltd. guarantees that our Nicotine USP meets or exceeds all regulatory and pharmacopoeial specifications, including:
- Purity: ≥99.8%
- Moisture Content: ≤0.5%
- Residual Solvents: Below regulatory limits
- Heavy Metals: ≤10 ppm
- Specific Optical Rotation: -134° to -137°
- pH (1% solution in water): 7.5 – 8.5
- Boiling Point: 247°C
- Flash Point: 95°C
Our in-house quality control laboratories conduct rigorous testing to ensure that our Nicotine USP meets the highest standards before it reaches our customers.
Solubility
Nicotine USP is highly soluble in various solvents, making it ideal for pharmaceutical formulations.
- Water Solubility: Miscible
- Soluble in: Alcohol, Ether, Chloroform
- Insoluble in: Non-polar solvents such as Hexane
This versatile solubility profile allows for easy formulation into different dosage forms, ensuring efficient drug delivery in pharmaceutical applications.
Assay of Nicotine USP
The assay of Nicotine USP determines its potency and purity, ensuring compliance with USP monographs.
- Assay by Titration: ≥99.8% (w/w)
- Assay by GC/HPLC: ≥99.9% (w/w)
Our high-purity Nicotine USP is tested with titrimetric analysis and chromatographic methods to confirm its active pharmaceutical ingredient (API) content before release.
Chromatographic Purity by HPLC
High-Performance Liquid Chromatography (HPLC) is the preferred analytical technique for determining the chromatographic purity of Nicotine USP.
- Main Peak Purity: ≥99.9%
- Impurity Levels: Below 0.05%
- Retention Time: Consistent with reference standards
Our HPLC analysis ensures that Nicotine USP is free from degradation products, residual solvents, and unwanted alkaloids, providing pharmaceutical manufacturers with high-purity nicotine for drug formulations.
Why Choose Prism Industries Pvt. Ltd. for Nicotine USP?
1. High-Purity, Pharmaceutical-Grade Nicotine
We specialize in producing Nicotine USP with 99.9% purity, ensuring compliance with USP, EP, and GMP standards. Our product is free from harmful contaminants, making it ideal for nicotine replacement therapies (NRTs).
2. Advanced Manufacturing & Quality Assurance
Our state-of-the-art manufacturing facilities utilize cutting-edge extraction and purification technologies to deliver the highest-quality Nicotine USP. We follow strict GMP protocols to maintain batch-to-batch consistency.
3. Compliance with Global Regulations
Our Nicotine USP meets international regulatory requirements, including USP, EP, REACH, and FDA standards. We provide comprehensive regulatory documentation to support pharmaceutical manufacturers.
4. Reliable Bulk Supply & Customization
As a leading bulk drugs manufacturer, we offer Nicotine USP in customizable concentrations and packaging options to meet the specific needs of our clients. Our bulk supply chain ensures uninterrupted availability.
5. Competitive Pricing & Fast Delivery
We provide cost-effective pricing without compromising on quality. With global distribution networks, we ensure fast and efficient delivery of Nicotine USP to our customers worldwide.
6. Expert Technical & Regulatory Support
Our team of pharmaceutical scientists and regulatory experts assists clients with technical queries, regulatory documentation, and formulation guidance to optimize their nicotine-based pharmaceutical products.
7. Commitment to Sustainability
At Prism Industries Pvt. Ltd., we emphasize eco-friendly and sustainable production methods, ensuring that our Nicotine USP is manufactured with minimal environmental impact.
Partner with Prism Industries Pvt. Ltd. for Premium Nicotine USP
If you are looking for a trusted API manufacturer for Nicotine USP, Prism Industries Pvt. Ltd. is your ideal partner. With a proven track record in API manufacturing, we deliver high-quality, regulatory-compliant nicotine for pharmaceutical and research applications.
Contact us today for bulk inquiries and regulatory support. Let’s innovate together for a healthier future! 
New headquarters, new possibilities
Related Products
Our minimum order quantities vary depending on the product:
- Active Pharmaceutical Ingredients (APIs): 1 kg
- Excipients: 5 kg
- Finished Dosage Forms: 1,000 units
- Custom Orders: Determined on a case-by-case basis
We accept the following payment methods:
- Bank Transfers: EUR, USD, GBP
- Credit/Debit Cards: Visa, MasterCard
- PayPal: For international transactions
API Pharmaceutical Manufacturing Company is a dedicated manufacturer of high-quality pharmaceutical ingredients and finished products. We control the entire production process to ensure compliance with the highest standards of quality and safety.
We primarily serve business clients in the pharmaceutical, biotech, and healthcare industries. For individual customers, we recommend reaching out to our authorized distributors.