phenylepherine hcl phenylepherine hydrochloride PhenylepherineHcl
we have GMP CEP USFDA DMF and Writtern confirmation ,it conforms the USP37/EP7.0
Character |
White or almost white, crystalline powder |
Identification A |
Optical Rotation |
Identification B |
Melting point of base :171℃~176 ℃ |
Identification C |
IR test |
Identification D |
Copper Sulphate test |
Identification E |
Chloride Reaction |
Acidity or Alkalinity |
Complies |
Appearance of Solution |
Clear |
|
Colourless |
Melting point |
About 143℃ |
Specific Optical Rotation |
- 43° to – 47° |
Related Substances |
Impurity C、E≤0.1% |
|
Unspecified impurity≤0.10% |
|
Total impurities ≤ 0.2% |
Sulphates |
Not more than 500 ppm |
Loss on Drying |
Not more than 1.0 % |
Sulphated Ash |
Not more than 0.1 % |
Assay |
98.5 to 101.0 % |
Particle Size |
98% past 40 Mesh |
Residual Solvents |
Methanol ≤3000 ppm |
|
2-Propanol ≤5000 ppm |
|
Ethanol ≤5000 ppm |
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