Albuterol sulphate CAS NO.51022-70-9

Product Name	Salbutamol Sulphate / Albuterol Sulfate
CAS No.	51022-70-9
Molecular Formula	2(C13H21NO3)H2O4S
Molecular Weight	576.7
Melting Point	180.C

Test	Specification	Results
Characteristics	White or almost white crystalline powder	White crystalline powder.
Identification	A. UV specific absorption / A 1% 1CM: 66-75	69.24
	B. by TLC ; C. by IR;	Complies as per BP; Complies
	D. by Color Reaction	Complies
Solubility	Freely soluble in ethanol (96%), sparingly soluble in water, slightly soluble in ether	Complies
Melting Range	152.0 –159.0℃	154.0℃
Clarity and colour of solution	2% solution in methanol is clear and not more intensely colored that reference solution BY5	Complies
Optical Rotation:	-0.10° ~ +0.10°;	+0.0°
Appearance of Solution	Solution is clear & not more intensely color than reference standard BY5 (method II)	Complies as per BP
Related substances ( by HPLC)	Single impurity D,F,G: NMT: 0.30%;	Impurity A: 0.067%;
	Single impurity A,B,C,E,H,I: NMT: 0.30%	Not detected;
	Unspecified impurity: NMT0.1%;	Unspecified impurity: 0.079%
	Total impurities: NMT1.0%	0.00071
Imputiry J (Absorbance at 310)	0.1% w/w max.	0.00015
Boron	≤ 50PPM	30.54PPM
Residual solvents	Methanol: NMT3000ppm;	Methanol: 312ppm;
Residual solvents	Ethyl Acetate: NMT5000ppm	Ethyl Acetate: 69ppm
Loss on drying	≤0.5% (W/W)	0.0018
Sulfated Ash	≤0.10% (W/W)	0.0003
Assay (On dried basis)	98.00% --101.00% (W/W)	0.992
Conclusion	Conforms to BP2019