N-acetyl cysteine powder
From 1 kg
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N-acetyl cysteine
PRODUCT INFORMATION
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TECHNICAL DATA SHEET |
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REFERENCE Nº: AMI-034 |
REVIEW: 7 |
DATE: 02.2022 |
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PRODUCT NAME |
N-ACETYL-L-CYSTEINE |
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MOLECULAR FORMULA |
C5H9NO3S |
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MOLECULAR WEIGHT |
163.2g/mol |
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CAS Nº |
616-91-1 |
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EINECS Nº |
210-498-3 |
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INCI NAME |
Acetylcysteine |
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GEOGRAPHICAL ORIGIN |
Asia |
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SOURCE |
Synthetic-Fermentation |
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CARRIER |
Absence |
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PHYSICAL AND CHEMICAL ASSAY |
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SPECIFICATIONS |
STANDARD |
MÉTODO / METHOD |
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APPEARANCE |
White crystalline powder or colourless crystals |
Visual |
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IDENTIFICATION (IR) |
Positive |
USP |
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PARTICLE SIZE |
95% pasa / through 20 mesh |
Internal Method |
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LOSS ON DRYING |
≤ 1.0% |
USP |
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ASH |
≤ 0.2% |
USP |
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pH |
2.0 - 2.8 |
USP |
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SPECIFIC ROTATION |
+21.3º a / to +27.0º |
USP |
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CHLORIDES |
≤0.04% |
Internal Method |
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SULPHITES |
≤0.03% |
Internal Method |
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AMMONIUM |
≤0.02% |
Internal Method |
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IRON |
≤20 ppm |
Internal Method |
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RESIDUAL SOLVENTS |
Complies |
Reg. 2009/32/EC |
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SOLUBILITY |
Freely soluble in water and alcohol |
Internal Method |
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RELATED SUBSTANCES |
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L-Cystine |
≤ 0.5% |
Ph. Eur. / EP |
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L-Cysteine |
≤ 0.5% |
Ph. Eur. / EP |
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N,N-diacetyl-L-Cystina |
≤ 0.5% |
Ph. Eur. / EP |
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N,N-diacetyl-L-Cysteine |
≤ 0.5% |
Ph. Eur. / EP |
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Individual Impurity |
≤ 0.5% |
Ph. Eur. / EP |
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Total impurities |
≤ 2.0% |
Internal Method |
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ASSAY |
98.5-101.0% |
USP |
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SPECIFICATIONS |
STANDARD |
METHOD |
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HEAVY METALS (as Pb) |
≤10 ppm |
USP |
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ARSENIC |
≤0.5 ppm |
USP |
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LEAD |
≤1 ppm |
USP |
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CADMIUM |
≤0.5 ppm |
USP |
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ZINC |
≤10 ppm |
Internal Method |
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MERCURY |
≤0.1 ppm |
USP |
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MICROBIOLOGICAL ASSAY |
STANDARD |
METHOD |
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TOTAL PLATE COUNT |
≤1 000 ufc/g |
USP |
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YEASTS & MOULD |
≤100 ufc/g |
USP |
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ENTEROBATERIACEAE |
Absence/10g |
ISO |
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COLIFORMS |
Absence/g |
USP |
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BACILLUS SP. |
Absence/g |
GB |
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CLOSTRIDIUM SP. |
Absence/g |
USP |
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E. COLI |
Absence/g |
USP |
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S. AUREUS |
Absence/g |
USP |
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SALMONELLA |
Absence/25g |
USP |
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OTHER INFORMATIONS |
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USE: Food, Cosmetic. |
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Product Suitable for Vegans and Vegetarians. |
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Product with Halal and Kosher certificate. |
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Free Residual Solvents conforms to the Dir. 2009/32/EC and Dir. 2010/59/EU. |
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Free BSE/TSE product conforms to the Reg. (EC) No 999/2001. |
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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. |
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Free GMO product conforms to the Reg. Nº 1829/2003/EC & Nº 1830/2003/EC. |
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NON Irradiated and NON IONIZED product conforms to the EU Dir. Nº 1999/2/CE and 1999/3/CE. |
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Product is NOT used with Nanomaterial Technology conforms Reg. (EU) Nº 1169/2011. |
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Free doping substances product (WADA list). |
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Free Contaminants product conforms to the Reg. (EC)1881/2006 and No 629/2008. |
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Free Pesticides product conforms to the Reg. (EC) No 396/2005. |
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Product conforms to the Reg. 10/2011 and 1935/2004 regarding materials in contact with food. |
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STORAGE: Keep container dry and tightly closed; Keep in a cool well-ventilated; Keep away from heat and oxidizing agents. |
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Best before:3 years. |
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Norms: Complies manufacturer´s specifications, USP and EP. |
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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 INTENTED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE. |
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