Technical data sheet
Reference Nº: AMI-034
Date: 01/12/2025
N-ACETYL-L-CYSTEINE
CAS Nº
616-91-1
EC/EINECS Nº
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 |
Specifications
Standard
Method
| 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 |
Metals
Pollutants
Standard
Method
| 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 analysis
Specifications
Standard
Method
| 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 |
Other 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
*Product characteristics may vary from one batch to another due to the origin of the raw materials used in its manufacture, their area of origin, or natural factors associated with them. These variations may affect parameters such as color, odor, taste, or moisture, without compromising its properties or quality.
*The technical data sheets are informative and may not be up-to-date. Please contact us for the latest version.
*Any additional information or supporting documentation will be provided upon request or against order.
All the raw materials we sell are strictly tested.
In our own quality laboratory in Spain.
Constant
stock rotation.
stock rotation.
To guarantee fresh batches at all times.
Punctuality and quality of delivery.
We deliver how, when and where you need it.
All our products are labeled and have their own documentation in English and Spanish.
Ask us whatever you might need; we’ll take care of it.
At Nutrifoods we are distributors of raw materials for the food supplement industry. We ship to more than 20 different countries all over the world, always making sure to meet the highest standards in terms of quality of customer service and guaranteed satisfaction. It’s easy to work with us.
