Specification No. T06
TROSPIUM CHLORIDE
(1R,3r,5S)-3-[(Hydroxydiphenylacetyl)oxy]spiro[8-azoniabicyclo[3,2,1]octane-8,1´-pyrrolidinium] chloride
Molecular Formula: C25H30ClNO3
Molecular Weight: 428.0
Description: White or almost white, crystalline powder. Very soluble in water, freely soluble in methanol, practically insoluble in methylene chloride.
| Tests: | Limits: | Methods: |
| Identification: I.R. spectrum | Ph. Eur. 5th Ed., <2.2.24> | |
| Identification: chloride | Ph. Eur. 5.2, page 3281 Ph. Eur. 5th Ed., <2.3.1> |
|
| Clarity of 10 % (w/v) aqueous solution: | clear | Ph. Eur. 5th Ed., < 2.2.1> |
| Color of 10 % (w/v) aqueous solution: | max. B7 | Ph. Eur. 5th Ed., < 2.2.2> |
| pH of 1 % (w/v) aqueous solution: | 5.0 – 7.0 | Ph. Eur. 5th Ed., < 2.2.3> |
| Impurity C (TLC): | max. 0.5 % | Ph. Eur. 5.2, page 3281 |
| Related substances (HPLC): | Ph. Eur. 5th Ed., <2.2.29> | |
| Impurity A | max. 0.3 % | Ph. Eur. 5.2, page 3281 |
| Impurity B | max. 0.5 % | Ph. Eur. 5.2, page 3281 |
| Any other impurity: | max. 0.1 % | Ph. Eur. 5.2, page 3281 |
| Total sum of impurities: | max. 1.0 % | Ph. Eur. 5.2, page 3281 |
| Loss on drying (105 °C): | max. 0.5 % | Ph. Eur. 5th Ed., <2.2.32> |
| Sulphated ash: | max. 0.1 % | Ph. Eur. 5th Ed., <2.4.14> |
| Assay (Argentometry, calculation calculation based on dry substance): | 99.0 – 101.0 % | Ph. Eur. 5th Ed., page 3282 |
| Ethanol (GC): |
max. 3000 ppm |
Ph. Eur. 5th Ed. 2005, <2.2.28> NQ T06, test No. 14 |
| Microbiological test: | ||
| Bacteria | max. 1000 cfu/g | Ph. Eur. 5th Ed. 2005, <2.6.12> |
| Fungi | max. 100 cfu/g | Ph. Eur. 5th Ed. 2005, <2.6.12> |
| Escherichia coli in 1g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Salmonella in 10g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Pseudomonas aeruginosa in 1g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Staphylococcus aureus in 1g | absent | Ph. Eur. 5th Ed. 2005, <2.6.13> |
| Shelf life: 12 months (to be understood as a retest date) | ||
Impurity A: Hydroxydiphenylacetic acid
Impurity B: (1R,3r,5S)-8-azabicyclo[3,2,1]oct-3-yl hydroxydiphenyl-acetate
Impurity C:(1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3,2,1]octane-8,1´-pyrrolidinium]
This specification supersedes the specification No. T06, version 1 issued on October 26, 2005.
*NQ = Norm of Quality
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