(S)-nicotine specification: what a certificate of analysis should show
A certificate of analysis is where a nicotine supplier's claims become numbers. This guide walks through the tests buyers check for (S)-nicotine, what the pharmacopoeias require, and what our first industrial batch measured.
Identity
(S)-Nicotine, also written (–)-nicotine or L-nicotine, is 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine: CAS 54-11-5, C10H14N2, 162.23 g/mol1. Synthetic and tobacco-derived (S)-nicotine are the same substance, so identity tests are the same for both. ESSENZ supplies it as the free base.
Assay and related substances
The European and US pharmacopoeias set the same limits for nicotine of any origin: an assay of 99.0–101.0% and total related substances of no more than 0.8%2. Related substances are the nicotine-like impurities a test can find, such as alkaloids from the plant or by-products of a synthesis.
| Test | Pharmacopoeia limit | ESSENZ, first industrial batch |
|---|---|---|
| Assay | 99.0–101.0% | 100.5% (potentiometric titration)3 |
| Total impurities | not more than 0.8% | 0.10%3 |
| Largest unknown single impurity | set by the specification | 0.03%3 |
| Purity (100% minus total impurities) | — | 99.9%3 |
Read assay and purity together. The assay measures how much nicotine is there; the impurity profile shows what else is there. A titration assay above 100% is normal within the method's precision.
Enantiomeric purity
Nicotine has a mirror-image form, (R)-nicotine. Tobacco-derived nicotine is about 99% (S), and racemic synthetic nicotine is a 50:50 mix4, so the share of (S) tells you which kind of nicotine you have. It is reported as enantiomeric excess (ee) or as specific rotation.
Our first industrial batch had an ee of 99.85% (S), which is 99.9% (S), and a specific rotation of −148.6°3.
Other tests on a nicotine certificate
Depending on the specification and the market, a certificate also covers appearance, identification, water content and residual solvents. For applications where nitrosamines matter, ask which nitrosamines are tested, by which method and to which limit of quantification; our TSNA guide explains why.
What we provide
- A certificate of analysis with every batch.
- The specification and the safety data sheet on request.
- Samples from 10 g, shipped within two weeks with a full certificate of analysis.
- Client audits of our manufacturing partner's GMP-certified site, under NDA.
Sources
- PubChem compound summary: Nicotine, CID 89594 (C10H14N2, 162.23 g/mol). Link ↗
- European Pharmacopoeia monograph 1452 (Nicotine) and USP monograph Nicotine: assay 99.0–101.0%, total related substances not more than 0.8%.
- ESSENZ certificate of analysis ESN-COA-2026-0920, first industrial batch NGD-20260920 (149 kg, produced 20 September 2026). Available on request.
- Cheetham A. G. et al. Analysis and differentiation of tobacco-derived and synthetic nicotine products: addressing an urgent regulatory issue. PLOS ONE 17(4): e0267049 (2022). Link ↗