N-Acetyl-L-Cysteine

CAS No.: 616-91-1
Molecular formular: C₅H₉NO₃S
Molecular weight: 163.19

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N-Acetyl-L-Cysteine	AJI92	USP2025	EP11	JP18
Appearance	White crystals or crystalline powder	White crystalline powder	White or almost white, crystalline powder or colourless crystals	White crystals or crystalline powder
ldentification	Conform	Conform	IR: Conform to CRS Spectrum	IR: Conform to CRS Spectrum
State of solution (Transmittance)	Clear and colorless, ≥98.0%	/	/	/
Specific rotation	+21.3° ~ +27.0°	/	+21.0° ~ +27.0° (dried substance)	+21.0° ~ +27.0° (on the dried basis)
Optical rotation	/	+21º ~ +27 º	/	/
Chloride	≤0.04%		/	≤0.040%
Sulfate	≤0.030%		/	≤0.030%
Ammonium	≤0.02%	/	/	≤0.02%
Iron	≤20ppm	/	/	≤10ppm
Heavy metals	≤10ppm	/	/	≤10ppm
Arsenic	≤1ppm	/	/	/
Other amino acids	Chromatographically not detectable	/	/	/
Loss on drying	≤0.5%	≤1.0%	≤1.0%	≤0.5%
Residue on ignition	≤0.20%	≤0.5%	≤0.2%	≤0.3%
pH	2.0 ~ 2.8	2.0 ~ 2.8	/	/
Assay	98.5% ~ 101.0%	98.0% ~ 102.0% (on the dried basis)	98.5% ~ 101.0% (dried substance)	99.0% ~ 101.0% (on the dried basis)
Appearance of solution	/	/	The solution is clear and colourless	/
Related compounds	/	/	Impurity C: ≤ 0.3%	The area of the peak other than acetylcysteine: ≤0.3%
			Impurity B: ≤ 0.2%	The area of the peak other than acetylcysteine: ≤0.3%
			Impurity D: ≤ 0.15%	The total area of the peak other than acetylcysteine: ≤0.6%
			Unspecified impurities: each impurity: ≤ 0.1%
			Total: ≤ 0.5%
Melting point	106°~110°	/	/	107℃ ~ 111℃
Zinc	/	/	≤10ppm	/