Product Description
Nicotine Polacrilex 20% is a pharmaceutical-grade nicotine resin complex used primarily in nicotine replacement therapy (NRT) products such as gums, lozenges, and tablets. It consists of nicotine bound to a polacrilin resin, which provides a controlled and sustained release of nicotine in the body, helping individuals reduce or quit smoking.
At Prism Industries Pvt. Ltd., we manufacture high-quality Nicotine Polacrilex 20%, ensuring strict compliance with international pharmaceutical standards. Our Nicotine Polacrilex 20% is formulated with precision, offering excellent bioavailability, stability, and efficacy for use in nicotine replacement products.
Identification
- Chemical Name: Nicotine Polacrilex
- Nicotine Content: 20%
- Molecular Formula of Nicotine: C10H14N2
- Molecular Weight of Nicotine: 162.23 g/mol
- CAS Number: [Specific CAS Number]
- Appearance: Off-white to light brown powder
- Odor: Characteristic nicotine-like odor
- Solubility: Partially soluble in water; freely soluble in acidic solutions
- Function: Used in nicotine gums and lozenges for smoking cessation therapy
Nicotine Polacrilex 20% is designed to bind to salivary ions, ensuring a controlled and gradual release of nicotine in the bloodstream when used in oral nicotine replacement products.
Regulatory Documents & Compliance
At Prism Industries Pvt. Ltd., we adhere to global regulatory requirements to ensure the safety, efficacy, and quality of Nicotine Polacrilex 20%. We provide the following regulatory documents:
- Certificate of Analysis (COA): Verifies product purity, potency, and compliance with specifications.
- Material Safety Data Sheet (MSDS): Contains safety, handling, and storage guidelines.
- Good Manufacturing Practices (GMP) Certificate: Certifies compliance with pharmaceutical manufacturing standards.
- USP/NF Compliance: Meets United States Pharmacopeia (USP) standards for Nicotine Polacrilex 20%.
- ICH Q3C Compliance: Ensures residual solvents meet international guidelines.
- Stability Studies Report: Demonstrates product stability under varied storage conditions.
- TSE/BSE-Free Certification: Confirms no animal-derived components.
- Allergen-Free Statement: Certifies the absence of common allergens.
We ensure that Nicotine Polacrilex 20% meets all regulatory and safety standards, making it safe and effective for pharmaceutical use.
Specifications of Nicotine Polacrilex 20%
Parameter | Specification |
Appearance | Off-white to light brown powder |
Odor | Characteristic mild nicotine odor |
Nicotine Content | 19.0% – 21.0% |
pH (5% Solution in Water) | 5.0 – 7.5 |
Loss on Drying | ≤ 5.0% |
Heavy Metals | ≤ 10 ppm |
Residual Solvents | Complies with ICH Q3C guidelines |
Particle Size Distribution | 90% passes through a 100-mesh sieve |
Microbial Limits | Complies with pharmacopeial standards |
Our Nicotine Polacrilex 20% meets stringent quality control and safety specifications, ensuring its suitability for pharmaceutical and nicotine replacement therapy applications.
Solubility of Nicotine Polacrilex 20%
The solubility properties of Nicotine Polacrilex 20% make it an ideal component in nicotine replacement therapies.
- Water: Partially soluble
- Ethanol: Slightly soluble
- Acidic Solutions: Freely soluble (in acidic pH environments, such as saliva)
- Saliva: Designed for gradual release upon contact with salivary ions
The controlled solubility of Nicotine Polacrilex 20% ensures a slow and steady release of nicotine, reducing withdrawal symptoms in smoking cessation therapy.
Assay of Nicotine Polacrilex 20%
The assay for Nicotine Polacrilex 20% is conducted using High-Performance Liquid Chromatography (HPLC) to determine nicotine purity and content.
HPLC Assay Method for Nicotine Polacrilex 20%
- Instrument: High-Performance Liquid Chromatography (HPLC)
- Mobile Phase: Acetonitrile: Buffer solution (60:40)
- Column: C18 (250 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.0 mL/min
- Detection Wavelength: 260 nm
- Injection Volume: 10 µL
- Retention Time: 4.8 ± 0.2 minutes
- Assay Specification: 19.0% – 21.0% nicotine content
Our Nicotine Polacrilex 20% consistently meets assay purity standards, ensuring pharmaceutical-grade nicotine content.
Chromatographic Purity by HPLC
Chromatographic purity testing by HPLC ensures that Nicotine Polacrilex 20% is free from unwanted impurities, degradation products, or residual solvents.
HPLC Conditions for Chromatographic Purity Analysis
- Mobile Phase: Acetonitrile: Phosphate Buffer (70:30)
- Column: C18 (150 mm × 4.6 mm, 5 µm)
- Flow Rate: 1.2 mL/min
- Detection Wavelength: 260 nm
- Retention Time: 4.5 ± 0.3 minutes
- Total Impurities Limit: ≤ 0.5%
Our Nicotine Polacrilex 20% undergoes strict quality control to ensure its purity and effectiveness in nicotine replacement therapy applications.
Key Applications of Nicotine Polacrilex 20%
- Nicotine Gums: Provides a controlled nicotine release to reduce smoking cravings.
- Nicotine Lozenges: Dissolves in the mouth, delivering nicotine in a sustained manner.
- Nicotine Tablets: Used for oral nicotine replacement therapy.
- Pharmaceutical Formulations: Included in prescription and over-the-counter smoking cessation products.
Our Nicotine Polacrilex 20% is widely used in the pharmaceutical industry for its efficacy in smoking cessation treatments.
Why Choose Prism Industries Pvt. Ltd. for Nicotine Polacrilex 20%?
As a leading manufacturer of Nicotine Polacrilex 20%, Prism Industries Pvt. Ltd. ensures:
High Purity: Nicotine content of 19.0% – 21.0%, meeting USP standards. Regulatory Compliance: Full adherence to GMP, USP, and ICH Q3C guidelines. Advanced Quality Control: Rigorous HPLC testing for assay and purity verification. Sustainable Manufacturing: Eco-friendly production processes. Global Supply Network: Reliable distribution for international markets.
Nicotine Polacrilex 20% is a highly effective nicotine resin complex used in nicotine replacement therapy (NRT). Its controlled release properties, high purity, and compliance with regulatory standards make it an ideal choice for nicotine gums, lozenges, and tablets.
At Prism Industries Pvt. Ltd., we manufacture premium Nicotine Polacrilex 20% with strict quality control and pharmaceutical-grade purity. If you need high-quality Nicotine Polacrilex 20%, contact us today for bulk supply and customized solutions.
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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.