HOME -> PRODUCTS -> N-ACETYL-L-CYSTEINE USP 23

 

N-ACETYL-L-CYSTEINE

SPECIFICATIONS


ITEMS

SPECIFICATIONS

Appearance

White crystalline powder

Assay

98.0 – 102.0%

Specific Rotation

+21.0 ~ +27.0

State of Solution

98.0% Min.

Chloride (Cl)

0.04% Max.

Ammonium (NH4)

0.02% Max.

Sulfate (SO4)

0.030% Max.

Iron (Fe)

20 ppm Max.

Heavy Metals

10 ppm Max.

L-Cystine

0.5% Max.

L-Cysteine

0.5% Max.

N,N-Diacetyl-L-Cysteine

0.5%Max.

N,S-Diacetyl-L-Cysteine

0.5% Max.

Other Impurities

0.5% Max.

Total Impurities

0.5% Max.

Organic Volatile Impurities

As per USP

Loss on Drying

1.0% Max.

Residue on Ignition

0.5% Max.

pH

2.0 – 2.8

Lead

3.7 ppm Max

Microbiological:

 

Total Plate Count

1,000 CFU/g Max.

Yeast/Mold

100 CFU/g Max.

E.Coli

Negative

Salmonella

Negative