Acarbose 56180-94-0 CAS NO.56180-94-0

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Items	Specification
Characters	White or yellowish amorphous powder , hygroscopic.
Identification	a. HPLC	The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution.
	b. IR	Consistent with reference standard
Specific optical rotation	+168°~+183° (anhydrous substance)
water	≤4.0%
pH	5.5~7.5
Absorbance	≤0.15. NMT 0.15 at 425nm.
Sulphated ash	≤0.2%
Heavy Metals	≤20ppm
Related Substances	Total Impurity		≤3.0%
	Any Impurity		≤0.2%
	Impurity A		≤0.6%
	Impurity B		≤0.5%
	Impurity C		≤1.5%
	Impurity D		≤1.0%
	Impurity E		≤0.2%
	Impurity F		≤0.3%
	Impurity G		≤0.3%
	Impurity H		≤0.2%
Assay (anhydrous substance)	96.0%~102.0%
Microbiological purity	Not more than 1000 aerobic bacteria per 1 g
	Not more than 100 fungi per 1 g
	Absence of Escherichia coli per 1 g
Conclusion	Conform to the EU Specification

 

 

 

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