Product Description
Nicotine Polacrilex 15% is a highly purified form of nicotine, bound to an ion-exchange resin. This product is designed to be used in various pharmaceutical and consumer products, especially in nicotine replacement therapies (NRTs) such as gums, lozenges, and other oral products. With a controlled release mechanism, it offers an effective and consistent delivery of nicotine, which is ideal for individuals looking to quit smoking or reduce their nicotine intake.
Manufactured under strict quality control guidelines, Nicotine Polacrilex 15% provides an excellent solution for controlled dosing. Its unique formulation allows for the gradual release of nicotine, helping to manage cravings and reduce withdrawal symptoms. This product is widely used by healthcare providers and manufacturers in the production of over-the-counter nicotine replacement products.
Key Features:
- 15% nicotine content for effective dose control
- High-quality, pharmaceutical-grade nicotine bound to polacrilex resin
- Ideal for use in nicotine replacement therapies (e.g., gums, lozenges)
- Provides consistent and gradual nicotine release
- Manufactured under Good Manufacturing Practice (GMP) conditions
- Meets all relevant regulatory standards for safety and efficacy
Applications:
- Nicotine replacement therapies (NRTs) for smoking cessation
- Pharmaceutical formulations for controlled nicotine release
- Over-the-counter nicotine gums, lozenges, and patches
- Research and development in nicotine pharmacokinetics
Identification
The identity of Nicotine Polacrilex 15% is confirmed using advanced analytical techniques to ensure it meets the required quality standards. The following methods are employed for accurate identification:
- Infrared (IR) Spectroscopy: The compound’s molecular structure is identified based on its unique infrared absorption spectra. Key functional groups, such as the nicotine base and the polacrilex resin, have distinctive absorption peaks in the IR spectrum.
- Nuclear Magnetic Resonance (NMR): The structure of Nicotine Polacrilex 15% is further validated by NMR, which allows for detailed observation of the compound’s molecular framework. The NMR spectrum provides information on the positioning of hydrogen and carbon atoms within the nicotine molecule.
- Mass Spectrometry (MS): Mass spectrometry is used to determine the molecular weight and fragmentation pattern of Nicotine Polacrilex. This confirms the identity and purity of the compound.
- Elemental Analysis: The elemental composition of Nicotine Polacrilex is analyzed to ensure the proper balance of nicotine and polacrilex resin, confirming the integrity of the formulation.
Regulatory Documents
Nicotine Polacrilex 15% complies with international regulations to ensure its safety and efficacy. Several key regulatory documents are available for this product, which provide assurance to consumers and manufacturers of its high quality:
- Certificate of Analysis (COA): The Certificate of Analysis for Nicotine Polacrilex 15% includes detailed batch-specific information such as the concentration of nicotine, purity, and compliance with relevant specifications. It provides transparency about the quality of the product.
- Safety Data Sheet (SDS): The Safety Data Sheet offers vital safety information regarding the handling, storage, and disposal of Nicotine Polacrilex 15%. It also includes hazard classification, personal protective equipment (PPE) recommendations, and emergency response guidelines in case of accidental exposure.
- Good Manufacturing Practice (GMP) Certification: Nicotine Polacrilex 15% is manufactured in accordance with GMP guidelines, ensuring the product’s quality, consistency, and safety. This certification indicates that the production process adheres to international standards for pharmaceutical products.
- ISO Certification: The manufacturing facility where Nicotine Polacrilex 15% is produced holds ISO 9001:2015 certification, confirming that it meets global standards for quality management systems.
- FDA Approval (If applicable): Nicotine Polacrilex 15% may be approved by the FDA for use in over-the-counter nicotine replacement products, offering further assurance of its safety and effectiveness in the relevant market.
Specifications
Nicotine Polacrilex 15% is produced to meet stringent quality standards and is tested to ensure it meets the following specifications:
- Appearance: White to off-white powder or resinous material
- Nicotine Content: 15% w/w nicotine by weight
- Molecular Formula: [Insert Molecular Formula]
- Molecular Weight: [Insert Molecular Weight]
- Melting Point: Not applicable (resin-based formulation)
- Solubility: Soluble in water and ethanol; insoluble in non-polar solvents
- Purity: ≥ 95% (determined by HPLC or other suitable methods)
- Particle Size: [Insert specification if applicable]
- Storage Conditions: Store in a cool, dry place, away from direct sunlight and moisture
- Packaging: Available in multiple sizes, including 10g, 100g, and 500g containers, depending on customer needs
Note: Batch-specific certificates and analysis reports are available upon request to ensure the product meets the specific needs of different applications.
Assay
The assay of Nicotine Polacrilex 15% is performed to determine the exact nicotine content in the compound, which is crucial for maintaining accurate dosage in nicotine replacement therapies (NRTs). The assay is typically conducted using High-Performance Liquid Chromatography (HPLC) with ultraviolet (UV) detection to ensure the correct concentration of nicotine.
Assay Specifications:
- Method: High-Performance Liquid Chromatography (HPLC)
- Active Ingredient: Nicotine
- Purity: ≥ 95% nicotine content by weight
- Detection Wavelength: 254 nm (UV detection)
- Impurity Limitations: No significant peaks other than nicotine are detected in the chromatogram
- Limit of Detection (LOD): [Insert LOD specification]
The assay results are typically within the specified limits to ensure consistent nicotine content for precise dosing. This is crucial for formulating products that deliver an accurate and effective dose for smoking cessation.
Chromatographic Purity by HPLC
The chromatographic purity of Nicotine Polacrilex 15% is determined using High-Performance Liquid Chromatography (HPLC). This method is used to quantify the presence of any impurities and ensure the high purity of the nicotine compound. The HPLC analysis for Nicotine Polacrilex 15% ensures that the product complies with industry standards for purity and quality, making it suitable for use in pharmaceutical and consumer products.
HPLC Method Details:
- Column Type: C18 reverse-phase column or equivalent
- Mobile Phase: A mixture of water and acetonitrile, with or without pH modifiers as required
- Flow Rate: [Insert flow rate specification]
- Detection Method: UV detection at 254 nm
- Retention Time: [Insert specific retention time for nicotine]
- Purity: ≥ 95% nicotine, with no significant impurities detected
The chromatogram for Nicotine Polacrilex 15% typically shows a single, sharp peak corresponding to nicotine, with minimal or no impurities. Any detected impurities should be below regulatory limits, ensuring the product is safe for its intended use.
Nicotine Polacrilex 15% is a high-quality, pharmaceutical-grade product designed to deliver a consistent and controlled release of nicotine. Its precise nicotine content, high purity, and gradual release mechanism make it an ideal ingredient for nicotine replacement therapies, such as gums, lozenges, and patches. With its stringent regulatory compliance, proven assay methods, and chromatographic purity, this product provides a reliable and safe solution for those seeking to manage their nicotine intake.
Whether used for manufacturing or research purposes, Nicotine Polacrilex 15% ensures consistent quality and effectiveness in every batch, supporting the goal of helping individuals quit smoking and reduce nicotine dependence.
For more details or to place an order, please contact our customer service team or visit our website.
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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.