Technical data sheet
N° de référence DIV-186-1
Date : 01/11/2025
L-BITARTRATE CHOLINE
N° CAS
87-67-2
| CHEMICAL IDENTIFICATION | |
| UIPAC NAME | (2-Hydroxyethyl) trimethylammonium bitartrate |
| MOLECULAR FORMULA | C9H19NO7 |
| MOLECULAR WEIGHT | 253.25 g/mol |
| GEOGRAPHICAL ORIGIN | Europe |
| APPEARANCE | White,,crystalline, hygroscopic powder |
| ODOUR | Characteristic |
| TASTE | Characteristic |
Spécifications
Standard
Méthode
| IDENTIFICATION | ||
| IR* | Complies | USP |
| Test B* | Complies | USP |
| SPECIFIC ROTATION* | to +18.5º | USP |
| pH (10% solution) | 3.0 – 4.0 | USP |
| WATER (w/w) | ≤0.5% | USP |
| RESIDUE on IGNITION (prior to conditioning) | ≤0.1% | USP |
| RELATED SUBSTANCES* | ||
| CHOLINE related compound A* | ≤0.1% | USP |
| Any unspecified impurity | ≤0.1% | USP |
| Total Impurities | ≤0.5% | USP |
| RESIDUAL SOLVENTS* | Passes test | USP |
| 1,4-Dioxane | ≤10 ppm | USP |
| E 551, SILICON DIOXIDE (conditioning agent) w/w | 0.5 – 1.0% | USP |
| TOTAL AMINES as TMA | ≤10 ppm | USP |
| PARTICLE SIZE: 80 mesh | ≤10% | Internal Method |
| PARTICLE SIZE: 40 mesh | ≤2% | Internal Method |
| SOLUBILITY | Soluble in water ca. 330 g/l (24°C). Soluble in ethanol ca. 20 g/l, practically insoluble in ether and soluble in glycerol ca. 10g/l. | Internal Method |
| ASSAY prior to conditioning | ≥99.0% | USP |
| ASSAY after conditioning | ≥98.0% | USP |
Métaux
Polluants
Standard
Méthode
| ARSENIC* | ≤2 ppm | USP |
| LEAD* | ≤0.3 ppm | USP |
| Analysis regularly performed from selected lots in compliance with documented quality control program |
Microbiological assay
Spécifications
Standard
Méthode
| TOTAL PLATE COUNT | ≤300 ufc/g | Internal Method |
| YEASTS AND MOULD | ≤30 ufc/g | Internal Method |
| TOTAL COLIFORMS | Negative/10g | Internal Method |
| ENTEROBACTERIACEAE | Negative/10g | Internal Method |
| CRONOBACTER spp. | Negative/10g | Internal Method |
| E. COLI | Negative/10g | Internal Method |
| STAPHYLOCOCCUS AUREUS | Negative/10g | Internal Method |
| SALMONELLA | Negative/25g | Internal Method |
| BACILLUS CEREUS | ≤10 ufc/g | Internal Method |
| LISTERIA MONOCYTOGENES | Negative/25g | Internal Method |
Autres informations
Food grade product conforms to the Reg. (EC) No 178/2002 & No 852/2004.
Product is suitable for Vegans and Vegetarians.
Product with Kosher and Halal Certificate.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Free BSE/TSE product conforms to Reg (CE) 999/2001.
Allergens Free Product conforms to the Reg. (EU) Nº 1169/2011.
Contaminants Free Product conforms to the Reg. (EU) Nº 2023/915.
Pesticides Free Product conforms to the Reg. (EC) Nº 396/2005.
Residuals Solvents Free Product conforms to the Dir. 2009/32/EC.
STORAGE: Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials. Eliminate all ignition sources. Separate from oxidizing materials. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications, USP, FCC and Reg. (EU) No 231/2012.
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 is suitable for Vegans and Vegetarians.
Product with Kosher and Halal Certificate.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Free BSE/TSE product conforms to Reg (CE) 999/2001.
Allergens Free Product conforms to the Reg. (EU) Nº 1169/2011.
Contaminants Free Product conforms to the Reg. (EU) Nº 2023/915.
Pesticides Free Product conforms to the Reg. (EC) Nº 396/2005.
Residuals Solvents Free Product conforms to the Dir. 2009/32/EC.
STORAGE: Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials. Eliminate all ignition sources. Separate from oxidizing materials. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications, USP, FCC and Reg. (EU) No 231/2012.
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.
*Les fiches techniques sont informatives et peuvent ne pas être à jour. Veuillez nous contacter pour obtenir la dernière version.
*Toute information supplémentaire ou documentation complémentaire sera fournie sur demande ou contre commande.
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