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%