Technical data sheet
N° de référence DIV-431
Date : 01/06/2025
TALC PHARMACEUTIQUE
N° CAS
14807-96-6
Nº EC/EINECS
238-877-9
| CHEMICAL IDENTIFICATION | |
| MOLECULAR FORMULA | Mg3H2(SiO3)4 |
| MOLECULAR WEIGHT | 379.259 g/mol |
| CHEMICAL NAME | dioxosilane;oxomagnesium;hydrate |
| REACH STATUS | Exempt |
| ORIGIN | Mineral |
| GEOGRAPHICAL ORIGIN | Europe |
| APPEARANCE | Light homogeneous white or oily to the touch homogeneous light powder |
| ODOUR | Characteristic |
| TASTE | Characteristic |
Spécifications
Standard
Méthode
| IDENTIFICACIÓN | Conforms | EP, USP, JP |
| ACID or ALKALINITY | Conforms | EP, USP, JP |
| ASBESTOS | Absence | Internal Method |
| WHITENESS Y (Minolta CR.400) | 91 – 94% | Internal Method |
| RESIDUE on 75µm SIEVE (Alpine 200 LS) | <0.2% | Internal Method |
| LOSS ON IGNITION | ≤7% | EP, USP, JP |
| WATER SOLUBLE SUBSTANCES | <10mg | EP |
| <5mg | USP | |
| <4mg | JP | |
| ACID SOLUBLE SUBSTANCES | ≤2% | JP |
| ALUMINIUM | ≤2% | EP, USP, JP |
| CALCIUM | ≤0.9% | EP, USP, JP |
| IRON | ≤0.25% | EP, USP, JP |
| MAGNESIUM | 17.0 – 19.5% | EP, USP, JP |
Métaux
Polluants
Standard
Méthode
| LEAD | ≤10.0ppm | EP, USP, JP |
| ARSENIC | ≤4.0ppm | JP |
Microbiological assay
Spécifications
Standard
Méthode
| TOTAL PLATE COUNT | <1 000ufc/g | Internal Method |
| YEASTS AND MOULD | <100ufc/g | Internal Method |
Autres informations
Use: Food, Pharma.
Product Suitable for Vegans and Vegetarians.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
GMO Free Product conforms to the Reg. (EC) 1829/2003 & 1830/2003.
Allergens Free Product conforms to the Reg. (EU) Nº 1169/2011 & Reg. (EC) No 1223/2009.
Product complies with Reg (EU) Nº 1272/2013 (Annex XVII) on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons.
Dioxins and PCB dioxins like are bellow the maximum permitted limit set by the EU.
Product Not contain elemental impurities and genotoxic impurities (ICH Guideline Q3D on elemental impurities; ICH Q3A (R2) Impurities in nwe drug substances; ICH Q3B (R2) Impurities in new drug substances).
Nanomaterial Technology UNTREATED product conforms to the Reg. (EU) Nº 1169/2011.
Free Residual Solvents product (ICH Q3C (R6)).
Free doping substances product (WADA list).
NON Irradiated product conforms to the EU Dir. Nº 1999/2/EC.
Product Not Tested on animals according Reg. (CE) Nº1223/2009.
Free CMR substances product, according to Reg. (EC) Nº 1223/2009.
Product Not listed in California Act Proposition 65, however it may contain respirable crystalline silica.
Product exempt from registration according annex V.7 (Naturally occuring substances not chemically modified) of Reg. (EC) Nº 1907/2016 as amended.
Product Not contain substances of very high concern (SVHC).
Product complies with Reg. (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Reg.(EC) No 1333/2008.
Product Not contain antioxidants and preservatives.
Store in cool, dry and well ventilated areas, store in tightly closed packages at temperatura between -5 – 45ºC, and realitve humidity 5-98%.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications EP, USP39-NF34 and JPC.
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 Vegans and Vegetarians.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
GMO Free Product conforms to the Reg. (EC) 1829/2003 & 1830/2003.
Allergens Free Product conforms to the Reg. (EU) Nº 1169/2011 & Reg. (EC) No 1223/2009.
Product complies with Reg (EU) Nº 1272/2013 (Annex XVII) on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons.
Dioxins and PCB dioxins like are bellow the maximum permitted limit set by the EU.
Product Not contain elemental impurities and genotoxic impurities (ICH Guideline Q3D on elemental impurities; ICH Q3A (R2) Impurities in nwe drug substances; ICH Q3B (R2) Impurities in new drug substances).
Nanomaterial Technology UNTREATED product conforms to the Reg. (EU) Nº 1169/2011.
Free Residual Solvents product (ICH Q3C (R6)).
Free doping substances product (WADA list).
NON Irradiated product conforms to the EU Dir. Nº 1999/2/EC.
Product Not Tested on animals according Reg. (CE) Nº1223/2009.
Free CMR substances product, according to Reg. (EC) Nº 1223/2009.
Product Not listed in California Act Proposition 65, however it may contain respirable crystalline silica.
Product exempt from registration according annex V.7 (Naturally occuring substances not chemically modified) of Reg. (EC) Nº 1907/2016 as amended.
Product Not contain substances of very high concern (SVHC).
Product complies with Reg. (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Reg.(EC) No 1333/2008.
Product Not contain antioxidants and preservatives.
Store in cool, dry and well ventilated areas, store in tightly closed packages at temperatura between -5 – 45ºC, and realitve humidity 5-98%.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications EP, USP39-NF34 and JPC.
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.
Toutes les matières premières que nous vendons sont strictement testées.
Dans notre propre laboratoire de qualité en Espagne.
Avec une rotation
constante du stock.
constante du stock.
Pour garantir des lots frais à tout moment.
Nous vous livrons la commande au moment.
À l’endroit et de la façon dont vous préférez.
Tous nos produits sont étiquetés et disposent de leur propre documentation en anglais et en espagnol.
Demandez-nous ce dont vous avez besoin, nous l’organisons pour vous.
À Nutrifoods nous sommes distributeurs de matières premières pour l’industrie des compléments alimentaires. Nous expédions vers plus de 20 pays dans le monde entier, en répondant toujours aux normes les plus élevées en termes de garantie et de qualité du service à la clientèle. Il est facile de travailler avec nous. Il est facile de travailler avec nous.
