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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हम एक ISO 14001:2015, ISO 45001:2018, ISO 9001:2015, ISO 22000:2005, GMP और GLP प्रमाणित कंपनी हैं।