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Description
Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate is produced by chemical synthesis. Subsequent washing and solvent elimination yield the desired substance in not less than 97% purity. The obtained substance is an isomeric mixture with a ratio of 1.98 : 1.00 for Z-isomer to E-isomer.
- Chemical Name: 2-Ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino)cyclohex-2-en-1-ylidene]acetate
- Molecular formula: C17H26N2O4
- CAS number: 1419401-88-9
- Molecular weight: 322.41 g/mol
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Characterisation | ||
| General properties | ||
| Appearance | Visual | Yellowish to yellow powder |
| Melting point | BP (Appendix V A) | 85 -120°C |
| Particle size | USP <786> | D(0.5) ≥1.2 µm |
| Solubility in Water | Commission Directive 92/69/EEC (1992) - Flask Method A6 | 0.45 g/L at 20°C |
| pH (1% in water) | Ph. Eur. 2.2.3 | 5.8-5.9 |
| Water content | Karl Fischer (Ph. Eur. 2.5.12) | ≤0.13% (w/w) |
| Identity | ||
| FT-IR | USP <854>; Ph. Eur. 2.2.40 | Observation of characteristic peaks at 2187, 1675, 1493, 1458, 1428, 1386, 1323, 1284, 1199, 1187, 1109, 1065, and 1025 cm-1. |
| HPLC-MS | HPLC-MS (Ph. Eur. 2.2.46; Ph. Eur. 2.2.29; Ph. Eur. 2.2.43) | The retention time of the main component corresponds to the retention time of the standard ±3%. Detection of molecular ions peaks as follows:
|
| UV/Vis (in ethanol) | USP <857> | The spectrum should cover whole UV-A region (320-400 nm) and most of the UV-B region (290-320 nm) with λmax at 385 nm ± 5 nm. Observation of two other peaks at 228.4 nm and 459.5 nm |
| Assay | ||
| Assay | HPLC-UV/Vis (Ph. Eur. 2.2.46; Ph. Eur. 2.2.29) | ≥97.0% |
| Impurities and incidental constituents | ||
| Residual Solvents | ||
| Class 2 solvents | Headspace-GC-MS (Ph. Eur. 2.2.28; Ph. Eur. 2.4.24) | ≤50 ppm |
| Elemental impurities | ||
| Arsenic | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤1 ppm |
| Lead | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤5 ppm |
| Nickel | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤2 ppm |
| Cadmium | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤2 ppm |
| Antimony | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤2 ppm |
| Mercury | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤1 ppm |
| Chromium | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤5 ppm |
| Cobalt | ICP-OES (ISO 11885/ISO 17294/ISO 21392) | ≤2 ppm |
| Other organic or inorganic impurities or toxins | ||
| Sum of impurities >0.1% | HPLC-UV/Vis (Ph. Eur. 2.2.46; Ph. Eur. 2.2.29) | ≤0.5% |
| Sum of impurities <0.1% | HPLC-UV/Vis (Ph. Eur. 2.2.46; Ph. Eur. 2.2.29) | ≤0.2% |
| 2-Ethoxyethanol | GC-FID (Ph. Eur. 2.2.28) | < 20 ppm |
| 3-methoxypropylamine | GC-FID (Ph. Eur. 2.2.28) | ≤500 ppm |
| Diethyl sulfate | Headspace-GC-MS (Ph. Eur. 2.2.28; Ph. Eur. 2.4.24) | <1 ppm |
| Nitrosamines | Challis et al., 1995[1] | <50 ppb |
Footnotes
Challis, B. C., Colling, J., Cromie, D. D. O., Guthrie, W. G., Pollock, J. R. A., Taylor, P., Telling, G. M., Wallace, L. (1995) A screening procedure for total N‐nitroso contaminants in personal care products: results of collaborative studies undertaken by a CTPA Working Group. International journal of cosmetic science, 17(6), 219-231.
Abbreviations
- BP: British Pharmacopoeia
- FID: Flame Ionisation Detection
- GC: Gas Chromatography
- HPLC: High Performance Liquid Chromatography
- ICP: Inductively Coupled Plasma
- ISO: International Organisation for Standardisation
- MS: Mass Spectrometry
- OES: Optical Emission Spectrometry
- Ph. Eur.: European Pharmacopoeia
- UPLC: Ultra Performance Liquid Chromatography
- USP: United States Pharmacopeia
- UV/Vis: Ultraviolet-Visible Spectroscopy/Detection.