Nicotine USP is a high-purity, pharmaceutical-grade active pharmaceutical ingredient manufactured in compliance with stringent United States Pharmacopeia (USP) standards. It is widely recognized for its exceptional quality, consistency, and effectiveness in regulated pharmaceutical applications.
This premium-grade nicotine appears as a clear to pale yellow oily liquid with a characteristic odor. It is highly soluble in water and organic solvents, making it suitable for diverse formulation requirements. Produced under controlled conditions, Nicotine USP ensures reliable performance, superior stability, and precise dosage control.
The product is extensively used in Nicotine Replacement Therapy (NRT) applications, including gums, lozenges, patches, and other advanced delivery systems. Its high purity and compliance with international pharmacopeial standards make it a preferred choice for pharmaceutical manufacturers, research institutions, and formulation developers worldwide.
Manufactured using advanced purification and quality control processes, Nicotine USP undergoes rigorous testing to meet strict specifications for identity, assay, impurities, and safety. This ensures that every batch delivers consistent quality, supporting the development of safe and effective pharmaceutical products.
With a strong focus on quality, compliance, and reliability, Nicotine USP serves as a trusted raw material for modern pharmaceutical formulations and innovation-driven healthcare solutions.
CERTIFICATEOF ANALYSIS
|
Product |
: NICOTINE USP |
Page 1 of 1 |
|
|
Batch No |
: NCT/04/07/2023 |
Mfg Date |
: JUL - 2023 |
|
A.R. No |
: FP/NCT/04/2023 |
Retest Date |
: JUN- 2025 |
|
Batch Size |
: 150.100 Kg |
Date of released |
: 26/07/2023 |
|
SR.NO |
TESTS |
SPECIFICATION |
RESULTS |
|
1 |
Appearance |
Colorless or brownish viscous Liquid, Volatile, hygroscopic. |
Complies |
|
2 |
Identification A & B |
A) IR Spectrophotometer B) By HPLC |
Complies Complies |
|
3 |
Solubility |
Soluble in water, Miscible with anhydrous ethanol |
Complies |
|
4 |
Water content |
NMT 0.50 % w/w |
0.16% w/w |
|
5 |
Specific Optical Rotation |
-130.0o to -143.0o |
-142.210 |
|
6 |
Related Substance By HPLC |
||
|
6.1 |
Nicotine related Compound E |
NMT 0.30 % |
Not detected |
|
6.2 |
Nicotine related Compound C |
NMT 0.30 % |
0.03% |
|
6.3 |
Nicotine related Compound F |
NMT 0.30 % |
0.01% |
|
6.4 |
Nicotine related Compound A |
NMT 0.30 % |
0.01% |
|
6.5 |
Nicotine related Compound D |
NMT 0.30 % |
0.12% |
|
6.6 |
Nicotine related Compound G |
NMT 0.30 % |
0.01% |
|
6.7 |
Nicotine related Compound B |
NMT 0.30 % |
0.03% |
|
6.8 |
Any Other Unspecified Impurity |
NMT 0.10 % |
0.01% |
|
6.9 |
Total Impurities |
NMT 0.80 % |
0.23% |
|
7 |
Assay By Potentiometer (Anhydrous basis) |
99.0 % to 101.0 % |
99.89% |
|
REMARK : As opinion of under signed product is Complies / Prescribe USP Specification. |
High purity with USP-grade compliance
Excellent solubility for versatile formulations
Ideal for Nicotine Replacement Therapy (NRT) products
Consistent batch-to-batch quality
Suitable for regulated pharmaceutical markets
Manufactured using advanced quality control processes


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