Specification No. M05
Trimecain hydrochloride
Mesocaine hydrochloride
2-(diethylamino)-N-(2,4,6-trimethylphenyl)acetamide-hydrochloride
Molecular Formula: C15H25ClN2O
Molecular Weight: 284.83
C.A.S. No.: [1027-14-1] Merck 12: 9830
Description: White powder.
| Tests: |
Limits: | Methods: |
| Identification: a) Melting point b) I.R. spectrum c) Chloride d) TLC |
140 - 142 °C |
Ph. B. MMII,<2.2.14> Ph. B. MMII,<2.2.24> Ph. B. MMII, p 5532 Ph. B. MMII, p 5532 |
| Clarity of 5 % (w/v) aqueous solution: | clear | Ph. B. MMII,<2.2.1.> |
| Color of 5 % (w/v) aqueous solution: |
colorless | Ph. B. MMII,<2.2.2.>, Method II |
| pH of 5 % (w/v) aqueous solution: |
4.0 - 6.0 | Ph. B. MMII,<2.2.3 > |
| Other organic compounds: | must pass the Ph. B. MMII p 5533 | |
| Mesidine: | must pass the Ph. B. MMII p 5533 | |
| Sulphate: | max. 0.05 % | Ph. B. MMII,<2.4.13> |
| Loss on drying (105 °C): | max. 4.0 % | Ph. B. MMII,<2.2.32> |
| Sulphated ash: | max. 0.1 % | Ph. B. MMII,<2.4.14> |
| Assay (acidimetric titration, calculation based on dry substance): | 98.5 - 101.0 % | Ph. B. MMII, p 5533 |
| Ethanol (GC): | max. 2000 ppm | NQ M 05, test No. 14 |
| Acetone (GC): | max. 2000 ppm | NQ M 05, test No. 15 |
| Toluene (GC): | max. 100 ppm | NQ M 05, test No. 16 |
| Diethylether (GC): | max. 100 ppm | NQ M 05, test No. 17 |
| Microbiological test: | Ph. B. MMII,<5.1.4> | |
| Total viable aerobic count | max. 100 cfu/g | |
| Total enterobacteria count | max. 10 cfu/g | |
| Pseudomonas aeruginosa in 1g | absent | |
| Staphylococcus aureus in 1g | absent | |
| Shelf life: 2 years | ||
- INTERPHARMA PRAHA, a.s., Komoranska 955, 143 10 Praha 12, Czech Republic
- Business Development: 00420-241 773 242
- Secretariat: 00420-241 773 242, Fax: 00420-241 773 235
- Email: