Technical data sheet
Reference Nº: AMI-034
Review: 7
Date: 01/02/2022
N-ACETYL CYSTEINE POWDER
CAS Nº
616-91-1
EC/EINECS Nº
210-498-3
| MOLECULAR FORMULA | C5H9NO3S |
| MOLECULAR WEIGHT | 163.2g/mol |
| INCI NAME | Acetylcysteine |
| GEOGRAPHICAL ORIGIN | Asia |
| ORIGEN | Synthetic-Fermentation |
| CARRIER | Absence |
Specifications
Standard
Method
| APPEARANCE | White crystalline powder or colourless crystals | Visual |
| IDENTIFICATION (IR) | Positive | USP |
| PARTICLE SIZE | 95% through 20 mesh | Internal Method |
| LOSS ON DRYING | ≤ 1.0% | USP |
| ASH | ≤ 0.2% | USP |
| pH | 2.0 – 2.8 | USP |
| SPECIFIC ROTATION | +21.3º to +27.0º | USP |
| CHLORIDES | ≤0.04% | Internal Method |
| SULPHITES | ≤0.03% | Internal Method |
| AMMONIUM | ≤0.02% | Internal Method |
| IRON | ≤20 ppm | Internal Method |
| RESIDUAL SOLVENTS | Complies | Reg. 2009/32/EC |
| SOLUBILITY | Freely soluble in water and alcohol | Internal Method |
| RELATED SUBSTANCES | ||
| L-Cystine | ≤ 0.5% | Ph. Eur. / EP |
| L-Cysteine | ≤ 0.5% | Ph. Eur. / EP |
| N,N-diacetyl-L-Cystina | ≤ 0.5% | Ph. Eur. / EP |
| N,N-diacetyl-L-Cysteine | ≤ 0.5% | Ph. Eur. / EP |
| Individual Impurity | ≤ 0.5% | Ph. Eur. / EP |
| Total impurities | ≤ 2.0% | Internal Method |
| ASSAY | 98.5-101.0% | USP |
Metals
Pollutants
Standard
Method
| HEAVY METALS (as Pb) | ≤10 ppm | USP |
| ARSENIC | ≤0.5 ppm | USP |
| LEAD | ≤1 ppm | USP |
| CADMIUM | ≤0.5 ppm | USP |
| ZINC | ≤10 ppm | Internal method |
| MERCURY | ≤0.1 ppm | USP |
Other informations
USE: Food, Cosmetic.
Product Suitable for Vegans and Vegetarians.
Product with Halal and Kosher certificate.
Free Residual Solvents conforms to the Dir. 2009/32/EC and Dir. 2010/59/EU.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
Free Allergens product conforms to the Dir. 2003/89/EC, Dir. 2005/26/EC, Dir. 2005/63/EC, Dir. 2006/142/EC and Reg. (EU) No 1169/2011.
Free GMO product conforms to the Reg. Nº 1829/2003/EC & Nº 1830/2003/EC.
NON Irradiated and NON IONIZED product conforms to the EU Dir. Nº 1999/2/CE and 1999/3/CE.
Product is NOT used with Nanomaterial Technology conforms Reg. (EU) Nº 1169/2011.
Free doping substances product (WADA list).
Free Contaminants product conforms to the Reg. (EC) 1881/2006 and No 629/2008.
Free Pesticides product conforms to the Reg. (EC) No 396/2005.
Product conforms to the Reg. 10/2011 and 1935/2004 regarding materials in contact with food.
STORAGE: Keep container dry and tightly closed; Keep in a cool, well-ventilated place; Keep away from heat and oxidizing agents.
Best before: 3 years.
Norms: Complies manufacturer´s specifications, USP and EP.
Product Suitable for Vegans and Vegetarians.
Product with Halal and Kosher certificate.
Free Residual Solvents conforms to the Dir. 2009/32/EC and Dir. 2010/59/EU.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
Free Allergens product conforms to the Dir. 2003/89/EC, Dir. 2005/26/EC, Dir. 2005/63/EC, Dir. 2006/142/EC and Reg. (EU) No 1169/2011.
Free GMO product conforms to the Reg. Nº 1829/2003/EC & Nº 1830/2003/EC.
NON Irradiated and NON IONIZED product conforms to the EU Dir. Nº 1999/2/CE and 1999/3/CE.
Product is NOT used with Nanomaterial Technology conforms Reg. (EU) Nº 1169/2011.
Free doping substances product (WADA list).
Free Contaminants product conforms to the Reg. (EC) 1881/2006 and No 629/2008.
Free Pesticides product conforms to the Reg. (EC) No 396/2005.
Product conforms to the Reg. 10/2011 and 1935/2004 regarding materials in contact with food.
STORAGE: Keep container dry and tightly closed; Keep in a cool, well-ventilated place; Keep away from heat and oxidizing agents.
Best before: 3 years.
Norms: Complies manufacturer´s specifications, USP and EP.
*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.
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