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Ipratropium bromide monohydrate pratropium Bromide Pharmaceutical intermediates
Items | Specifications | Result |
Appearance | White or almost white, crystalline powder | Almost white, crystalline powder |
Melting point | About 230ºC, with decomposition | 227ºC~229ºC, with decomposition |
Identification A | Infrared absorption spectrophotometry. Comparison: ipratropium bromide CRS. | Complies |
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 chromatogra obtained with reference solution. | Complies |
Identification C | To 5 ml of solution S(see tests), and 2 ml of dilute sodiumhydroxide solution R. No precipitate is formed. | Complies |
Identification D | To about 1mg add 0.2ml of nitri c acid R and evaporate to dryness on a water-bath. Dissolve the residue in 2ml of actone R and add 0.1ml of a 30g/L solution of potassiumhydroxide R in methano l R. A violet colour develops. | Complies |
Identification E | It gives reaction of bromides. | Complies |
Appearance of solution | The solution is clear and not more intensely coloured then reference solution GY7. | Complies |
PH | 5.0~7.5 | 6.2 |
Impurity A | NMT0.1% | Not detected |
Related substances | Impurity B, C: NMT 0.1% Impurity D: NMT 0.05% Unspecified impurities:for each impurity, NMT0.1% Total: NMT 0.25% Disregard limit: 0.03% Disregard the peak due to the bromide ion. |
Impurity B: Not detected; Impurity C: Not detected; Impurity D: Not detected; Unspecified impurities: not detected; Total: Not detected. |
Water | 3.9%~4.4% | 4.3% |
Sulfated ash | NMT 0.1% | 0.02% |
Assay | 99.0% to 100.5%(anhydrous substance) | 100.3% |
Residual solvents | Methano l: NMT 0.3% Aceton e: NMT 0.5% Isopropano l: NMT 0.5% Dichloromethan e: NMT 0.06% Chlorofor m: NMT 0.006% Toluen e: NMT 0.089% |
Not detected; 0.0005%; 0.2%; Not detected Not detected; Not detected. |
Conclusion | The test result comply with EP10.0. |
CAS No. | 66985-17-9 |
Molecular Formula | C20H32BrNO4 |
Molecular Weight | 430.38 |
Product Name | Ipratropium bromide monohydrate |
Appearance | White Powder |
Assay | 99%+ |
Melting point: 231 °C
Storage conditions: 2-8°C
Solubility H2O: soluble10mg/mL
Form: powder
Color:white
What is Ipratropium bromide
Ipratropium Bromide is a pharmaceutical ingredient used for for the treatment of chronic obstructive pulmonary disease and acute asthma
Ipratropium bromide (INN, trade names Atrovent, Apovent, Ipraxa, Aerovent and Rinatec) is an anticholinergic drug used for the treatment of chronic obstructive pulmonary disease and acute asthma.
Analysis of Report
Items |
Specification |
Result |
Assay |
99.0%-100.5% |
100.2% |
Apperance |
White or almost white crystalline powder |
Almost white crystalline powder |
PH |
5-7.5 |
5.9 |
Water |
3.9%-4.4% |
4.1% |
Related substances |
Total impurities≤0.25% Other unknown inpurity≤0.1% |
0.062% N.D |
Sulphated ash |
≤0.1% |
<0.1% |
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Our company is based on the optical valley biological city,making full use of the park policy advantages, focusing on the research and development of biological medicine.
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