Technical data sheet
N° de référence AMI-034
Date : 01/12/2025
N-ACÉTYL-L-CYSTEINE
N° CAS
616-91-1
Nº EC/EINECS
210-498-3
| CHEMICAL IDENTIFICATION | |
| MOLECULAR FORMULE | C5H9NO3S |
| INCI NAME | Acetylcysteine |
| MOLECULAR WEIGHT | 163.2g/mol |
| GEOGRAPHICAL ORIGIN | Asia |
| ORIGIN | Synthetic-Fermentation |
| CARRIER | Absence |
| APPEARANCE | White crystalline powder |
| ODOUR | Characteristic |
| TASTE | Characteristic |
Spécifications
Standard
Méthode
| IDENTIFICATION | ||
| Infrared spectrum | Complies | Internal Method |
| Test A (Specific optical rotation) | Complies | Internal Method |
| PARTICLE SIZE | through 20 mesh | Internal Method |
| LOSS ON DRYING | ≤ 0.5% | EP – USP |
| SULPHATED ASHES | ≤ 0.2% | EP – USP |
| pH | 2.0 – 2.8 | EP – USP |
| SPECIFIC ROTATION | to +27.0º | EP – USP |
| MELTING POINT | 104ºC – 110ºC | EP |
| TAPPED DENSITY | 0.75 – 0.85 g/ml | Internal Method |
| OTHER | ||
| Appearance of solution | Clear and colorless | EP |
| RELATED SUBSTANCES | ||
| A: L-Cystine | ≤ 0.1% | EP |
| B: L-Cysteine | ≤ 0.2% | EP |
| C: N,N-diacetyl-L-Cystina | ≤ 0.3% | EP |
| D: N,N-diacetyl-L-Cysteine | ≤ 0.15% | EP |
| Individual Impurity | ≤ 0.1% | EP |
| Total impurities | ≤ 0.5% | EP |
| SOLUBILITY | Freely soluble in water and in alcohol (96%), practically insoluble in methylene choride. | Internal Method |
| ASSAY | 98.5 – 101.0% | EP – USP |
Métaux
Polluants
Standard
Méthode
| HEAVY METALS | ≤10 ppm | USP |
| ARSENIC | ≤1 ppm | Internal Method |
| LEAD | ≤2 ppm | Internal Method |
| CADMIUM | ≤1 ppm | Internal Method |
| MERCURY | ≤0.1 ppm | Internal Method |
| ZINC | ≤5 ppm | EP |
Microbiological assay
Spécifications
Standard
Méthode
| TOTAL PLATE COUNT | ≤1 000 ufc/g | Internal Method |
| YEASTS AND MOULD | ≤100 ufc/g | Internal Method |
| E. COLI | Negative/25g | Internal Method |
| SALMONELLA | Negative/25g | Internal Method |
| S. AUREUS | Negative/25g | Internal Method |
Autres informations
Use: Food supplement conforms to the Reg. (EU) No 178/2002.
Product suitable for Vegetarians and Vegans.
Product with Kosher & Halal certified.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Allergens Free Product conforms to the Reg. (EU) No 1169/2011.
Contaminants Free Product conforms to the (EC) Reg. No 2023/915.
Free BSE/TSE product conforms to theREg. (EC) No 999/2001.
Pesticides Free Product conforms with Regulation (EC) No 396/2005.
Nanomaterial Technology UNTREATED product conforms to the Reg. (EU) No 1169/2011.
NON Irradiated product conforms to the EU Dir. No 1999/2/EC.
Residual Solvents Free Product conforms to the EU Dir. No 2009/32/EC.
Free doping substances product (WADA list).
Product is NOT treated with ETO.
STORAGE: Keep in well-closed containers under room temperature away from light, humidity and heat sources.
Shelf life: 3 years.
For the indicated regulations and directives, subsequent modifications are included.
ALL DATA SHOWN ARE FROM OUR SUPPLIER-MANUFACTURER. THE ABOVE INFORMATION DOES NOT EXEMPT FROM THE OBLIGATION TO IDENTIFY AND CONTROL THE PRODUCT IN RELATION TO THE INTENDED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE.
STORAGE CONDITIONS
Product suitable for Vegetarians and Vegans.
Product with Kosher & Halal certified.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Allergens Free Product conforms to the Reg. (EU) No 1169/2011.
Contaminants Free Product conforms to the (EC) Reg. No 2023/915.
Free BSE/TSE product conforms to theREg. (EC) No 999/2001.
Pesticides Free Product conforms with Regulation (EC) No 396/2005.
Nanomaterial Technology UNTREATED product conforms to the Reg. (EU) No 1169/2011.
NON Irradiated product conforms to the EU Dir. No 1999/2/EC.
Residual Solvents Free Product conforms to the EU Dir. No 2009/32/EC.
Free doping substances product (WADA list).
Product is NOT treated with ETO.
STORAGE: Keep in well-closed containers under room temperature away from light, humidity and heat sources.
Shelf life: 3 years.
For the indicated regulations and directives, subsequent modifications are included.
ALL DATA SHOWN ARE FROM OUR SUPPLIER-MANUFACTURER. THE ABOVE INFORMATION DOES NOT EXEMPT FROM THE OBLIGATION TO IDENTIFY AND CONTROL THE PRODUCT IN RELATION TO THE INTENDED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE.
STORAGE CONDITIONS
*Les caractéristiques du produit peuvent présenter des variations d’un lot à l’autre en raison de l’origine des matières premières utilisées dans sa fabrication, de leur zone de provenance ou de facteurs naturels qui leur sont associés. Ces variations peuvent affecter des paramètres tels que la couleur, l’odeur, le goût ou l’humidité, sans compromettre en aucun cas ses propriétés ni sa qualité.
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