Nicotine USP/EP is a high-grade nicotine product that meets the stringent quality standards set by the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP). This ensures its purity, safety, and compliance with regulatory requirements, making it an essential ingredient in the pharmaceutical and related industries.
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SR. NO. |
TEST PARAMETERS |
SPECIFICATIONS |
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1 |
Description |
Colorless to Slightly yellow liquid |
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2
|
Identification A (By IR Spectroscopy) |
Infrared absorption spectrum of sample should match with the Infrared absorption spectrum of the standard |
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Identification B (By HPLC)
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The retention time of the major peak of the sample solution corresponds to that of the Standard solution, as obtained in Assay. |
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|
3 |
Assay (By HPLC) On anhydrous basis |
98.0 % to 102.0 % |
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4 |
Organic impurities (By HPLC) |
Should comply. |
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|
Nicotine related Impurity A Nicotine related Impurity B Nicotine related Impurity C Nicotine related Impurity D Nicotine related Impurity E Nicotine related Impurity F Nicotine related Impurity G Any other unspecified impurity Total impurities |
NMT 0.30 % NMT 0.30 % NMT 0.30 % NMT 0.30 % NMT 0.30 % NMT 0.30 % NMT 0.30 % NMT 0.10 % NMT 0.80 % |
|
5 |
Water Determination (By KF) |
NMT 0.50% |
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6 |
Specific Optical Rotation (By Polarimeter) |
-130° to -143° |
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7 |
Elemental impurities (By ICP-MS) |
Should meet the limits as specified in USP <232> and ICH Q3D. |
