| Function: | Respiratory System Agents |
|---|---|
| Certification: | / |
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Samples: |
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Items
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Specification
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| Appearance |
White or almost white crystalline powder
|
| Melting point | About 230ºC,with decomposition |
| Identification A | Infrared absorption spectrophotometry(2.2.24). Comparison:ipratropium bromide CRS. |
| Identification B | Examine the chromatograms obtained in the test for impurity A. Results:the principal spot in the chromatogram obtained with the test solution is similar in position,colour and size to the principal spot in the cheomatogram obtained with reference solution(a). |
| Identification C | To 5 mL of solution S(see Tests),add 2 mL of dilute sodiumhydroxide solution R.No precipitate is formed. |
| Identification D | To about 1 mg add 0.2mL of nitric acid R and evaporate todryness on a water-bath.Dissolve the residue in 2 mL of acetone R and add 0.1mL of a 30 g/L solution of potassiumhydroxide R in methanol R.A violet colour develops. |
| Identification E | It gives reaction(a) of bromides(2.3.1). |
| Appearance of solution | The solution is clear and not more intensely coloured than reference solution GY7 |
| pH | 5.0~7.5 |
| Impurity A | ≤0.1% |
| Related substances | Impurity D:NMT 0.05%;Impurity B,C:NMT 0.1%;Unspecified impurities:for each impurity,NMT 0.10%;Total:NMT0.25%;disregard limit:0.03%;disregard the peak due to the bromide ion. |
| Water | 3.9%~4.4% |
| Sulfated ash | ≤0.1% |
| Assay | 99.0%~100.5%(anhydrous substance) |
| Residual solvents | Methanol:NMT0.3%;Acetone:NMT0.5%;Isopropanol:NMT0.006%;Toluene:NMT0.089% |
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