Product Description
Chemical Name : 2-Propenoic acid, 2-methyl-, polymer with diethenylbenzene,complex with (S)-3-(1-methyl-2-pyrrolidinyl)pyridine; Methacrylicacid polymer with divinylbenzene, complex with nicotine.
Molecular Formula : [(C4H6O2)x(C10H10)y](C10H14N2)
Reference Pharmacopoeia : USP 43
CAS No. : 6019-06-3
Material Code : NCTP
Sampling Plan : n = N
Re-Test parameter : Complete analysis
Re-Test Date : 06 Months
Sampling Quantity : 50gm
Quantity for Control sample : 30gm
Standard Pack Size : As per customer Requirement
Packaging and Storage : Packed in an airtight container under nitrogen and protected fromlight.
Precautions : At the time of sampling use proper PPE like hand glows, mask, capand specs.
Test and Specification
1. Appearance White or almost white powder
2.Identification
a) BY IR: For Nicotine: Match IR Spectrum of the samplepreparation with IR spectrum of nicotine ditartratedihydrate USP RS
b) By IR: For Polacrilex: Match IR Spectrum of the samplepreparation with IR spectrum of USP Polacrilex resin RS
c) By HPLC: The retention time of the major peak of theSample solution corresponds to that of the Standardsolution, as obtained in the Assay3. Assay by HPLC NLT 95.0% and NMT 115.0% on the dried basis
4. Nicotine Release NLT 70% in 10 min
5. LOD at 105C for 2 Hr. NMT 7.0%
Reliable Quality and Regulatory ComplianceEach batch of Nicotine Polacrilex 20% is thoroughly tested and supplied with a Certificate of Analysis to guarantee compliance with pharmacopeial requirements. Impurity profiles and residual solvents strictly adhere to ICH and pharmacopeial guidelines, ensuring pharmaceutical grade safety and consistency for manufacturers and healthcare providers.
Flexible Packaging, Safe Handling, and TransportAvailable in HDPE or aluminum containers of customized sizes, our packaging options ensure the integrity and safety of Nicotine Polacrilex 20%. Not restricted under IATA or IMDG transport regulations, it can be imported and exported globally with ease while maintaining product quality throughout the supply chain.
FAQ's of Nicotine Polacrilex 20%:
Q: How should Nicotine Polacrilex 20% be stored to ensure maximum stability?
A: Nicotine Polacrilex 20% should be stored in a cool, dry place away from direct light. Proper storage helps maintain its stability and extends its shelf life up to two years as recommended.
Q: What is the primary use of Nicotine Polacrilex 20% in the pharmaceutical industry?
A: This active pharmaceutical ingredient is primarily used in nicotine replacement therapies, such as in the formulation of chewing gums and lozenges designed to aid individuals attempting to quit smoking.
Q: When is a Certificate of Analysis provided for Nicotine Polacrilex 20%?
A: A Certificate of Analysis, detailing critical quality parameters and compliance information, is supplied with every batch for complete transparency and assurance to customers.
Q: Where does Nicotine Polacrilex 20% meet regulatory and quality standards?
A: It complies with pharmacopeial standards for impurities, microbial limits, and identification, and meets ICH guidelines for residual solvents. All tests conform to authoritative regulatory benchmarks.
Q: What is the process for confirming the identity and purity of Nicotine Polacrilex 20%?
A: Identification is confirmed using Infrared (IR) and High Performance Liquid Chromatography (HPLC) methods. An impurity profile and residual solvent content are assessed for each batch to ensure pharmaceutical grade quality.
Q: How is Nicotine Polacrilex 20% typically packaged and transported?
A: The product is packaged in secure HDPE or aluminum containers, with sizes customizable to customer needs. It is not considered restricted for transport under IATA/IMDG guidelines, ensuring safe and convenient shipping.
Q: What are the benefits of using Nicotine Polacrilex 20% in nicotine replacement therapies?
A: Nicotine Polacrilex 20% offers controlled nicotine release, high purity, and compliant quality, supporting effective and safe nicotine delivery for smoking cessation products.