Certificate of analysis

Certificado de análisis

N-ACETYL-L-CYSTEINE
USP42

Batch Manufactured Expiration

C103-202112316F 16/12/2021 09/12/2024
Characters White crystalline powder Conforms
Identification Compare the infrared absorption spectrum of the sample with that of the standard Identical
atlas .
Specific rotation [α]D25 +21. 0 to +27.0 °°(on dried basis) +22.8º
pH 2.0 ~ 2.8 2.2
Assay 98.0 to 102.0%(on dried basis) 100.6%
Related substances
Impurity B L-Cysteine ≤0.2% ＜0.05%
Impurity C N,N-Diacetyl-L- ≤0.3% 0.05%
Cystine
Impurity D N,S-Diacetyl-L- ≤0.15% ＜0.05%
Cysteine
Unspecified impurities
Impurity A L-Cystine ≤0.10% ＜0.05%
Any other impurity ≤0.10% ＜0.05%
Total ≤0.5% 0.10%
Chloride Not more than 0.04% <0.04%
Zinc Not more than 0.001% <10 ppm
Heavy metals (Pb) Not more than 0.001% < 0.001%
Loss on Drying Not more than 1.0% 0.08%
Residue on ignition (sulfated) Not more than 0.5% 0.05%
Lead Not more than 3ppm < 3ppm
Arsenic (as AS2O3) Not more than 1ppm < 1ppm

| Information included in this document is provided as supplied by the manufacturer/supplier. Certificate of analysis as received from our supplier. | PQ Gonmisol S.A. |
 Certificate of analysis

Certificado de análisis

N-ACETYL-L-CYSTEINE
USP42

Batch Manufactured Expiration

C103-202112316F 16/12/2021 09/12/2024
Cadmium Not more than 1ppm < 1ppm
Mercury (Hg) Not more than 0.1ppm < 0.1ppm
Microbiology
Total plate count Less than 1000 cfu/g Conforms
Mold and yeast Less than 100 cfu/g Conforms
E-coli Negative Negative
Salmonella Negative Negative
S. Aureus Negative Negative

Conclusion : Agree with the specification of USP42.

| Information included in this document is provided as supplied by the manufacturer/supplier. Certificate of analysis as received from our supplier. | PQ Gonmisol S.A. |