Technical data sheet
Reference Nº: DIV-431
Date: 01/06/2025
PHARMACEUTICAL TALC
CAS Nº
14807-96-6
EC/EINECS Nº
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 |
Specifications
Standard
Method
| 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 |
Metals
Pollutants
Standard
Method
| LEAD | ≤10.0ppm | EP, USP, JP |
| ARSENIC | ≤4.0ppm | JP |
Microbiological analysis
Specifications
Standard
Method
| TOTAL PLATE COUNT | <1 000ufc/g | Internal Method |
| YEASTS AND MOULD | <100ufc/g | Internal Method |
Other 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
*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.
