(l)-Ephedrine Hydrochloride USP
   
Molecular Formula : C10H15NO. HCl
Molecular Weight : 201.69
CAS No. : [50-98-6]
Chemical Name :
1. Benzenemethanol, œ-[1-(methylamino)ethyl]-, hydrochloride [R-(R*,S* )], salt
2. (1R,2S)-2-Methylamino-1-phenyl propan-1-ol Hydrochloride
Specifications :
1. Description : Colourless crystals or white crystalline powder
2. Identification : a) Infrared spectrum of sample is concordant with the reference spectrum.
b) A solution of sample respond to the test for chloride.
3. Solubility : Freely soluble in water and soluble in alcohol.
4. Melting range : Between 217° and 220°C; the range between beginning and end of melting does not exceed 2°C
5. Specific rotation : Between - 33.0° and - 35.5° ( 5 % solution in water )
6. Acidity & alkalinity : NMT 0.10 ml of 0.02 N H2SO4 or NMT 0.20 ml of 0.02 N
NaOH solution
7. Sulfate : Must pass the test. No turbidity develops within 10 min.
8. Ordinary impurities : NMT 2.0 %
9. Residue on ignition : NMT 0.1 %
10. Loss on drying : NMT 0.5 %
11. Organic volatile impurities : Must pass the test
12. Assay : Between 98.0 % and 100.5 % ( dried basis )
Therapeutic indications: Bronchodilator
Packing : Packed in double lined polyethylene bags in 25 kg fiber drums.
Storage : Store below 35°C.