Product	Tadalafil
Batch No.	202010003
Mfg. date	20201022
Perform standard	USP 36
ANALYSIS	STANDARD	RESULT OF ANALYSIS
Description	White to class white powder	Class white powder
Solubility	Freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride, practically insoluble in water.	Conforms
Specific rotation	+78.0°～84.0°	+82.1°
Identification	HPLC	Conforms
Ordinary impurities(Do not calculate isomer A+C)	Single impurity≤0.15%	0.08%
Ordinary impurities(Do not calculate isomer A+C)	Total impurities≤1.0%	0.42%
Calculate isomer	A≤0.3%	0.21%
	B≤0.1%	Not detected
	C≤0.1%	Not detected
Loss on drying	≤0.5%	0.35%
Residue on ignition	≤0.1%	Conforms
Heavy metal	20ppm	Conforms
Assay	97.5%~102.0%	99.6%
Conclusion：Conform to USP 36

Tadalafil

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