Nicotine Polacrilex USP, also known as nicotine gum, is a specialized form of nicotine that is widely used as a nicotine replacement therapy (NRT) product. It plays a crucial role in helping individuals reduce their dependence on tobacco by providing controlled amounts of nicotine. As a distinguished Nicotine Polacrilex USP supplier, Nico Orgo Marketing Pvt. Ltd. ensures that our products meet the stringent quality standards set by the United States Pharmacopeia (USP).
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Sr. No. |
Test Parameters |
Specification |
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1 |
Description |
White to off white Powder |
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2
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Identification A BY IR For Nicotine |
The infrared spectrum of the sample of upper hexane layer exhibits maxima at the same wavelengths as that of a similar preparation of USP Nicotine Bitartrate Dihydrate RS. |
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Identification B BY IR For Polacrilex Resin |
The infrared spectrum of the sample of the residue obtained from Assay preparation exhibits maxima at the same wavelengths as that of a similar preparation of USP Polacrilex Resin RS. |
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Identification C BY HPLC |
The retention time of the major peak in the chromatogram of the sample solution corresponds to that in the chromatogram of standard solution, as obtained in the Assay test. |
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3 |
Assay (by HPLC) On dried Basis |
95.0 % to 115.0 % of labelled amount of Nicotine |
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% Amount of Nicotine in Nicotine Polacrilex |
19.0 % to 23.0 % |
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4 |
Organic Impurity BY HPLC |
As per USP specification |
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Nicotine related compound E |
NMT 0.30% |
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Nicotine related compound C |
NMT 0.30% |
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Nicotine related compound F |
NMT 0.30% |
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Nicotine related compound A |
NMT 0.30% |
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Nicotine related compound D |
NMT 0.30% |
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Nicotine related compound G |
NMT 0.30% |
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Nicotine related compound B |
NMT 0.30% |
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Any other unspecified impurity |
NMT 0.10% |
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Total impurities BY HPLC |
NMT 0.80% |
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5 |
Loss on drying |
NMT 7.0% |
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6 |
Nicotine Release (By UV) |
NLT 70 % w/w |
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7 |
Elemental impurities (By ICP-MS) |
Should meet the limits as specified in USP <232> and ICH Q3D |
