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. |
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