Technical data sheet
Reference Nº: VIT-035
Review: 9
Date: 01/09/2023
BIOTIN POWDER
CAS Nº
58-85-5
EC/EINECS Nº
200-399-3
| MOLECULAR FORMULA | C10H16N2O3S |
| MOLECULAR WEIGHT | 244.3 g/mol |
| GEOGRAPHICAL ORIGIN | Asia |
| ORIGEN | Synthetic |
Specifications
Standard
Method
| APPEARANCE | White or almost white fine crystalline powder | VISUAL |
| ODOUR | Characteristic | OLFACTORY |
| IDENTIFICATION (A,B,C) | Positive | Ph. Eur. – USP / EP-USP |
| ASSAY (HPLC) | 97.50 – 102.00 % | USP |
| ASSAY (Tritación) | 98.50 – 101.00 % | Ph. Eur. / EP |
| LOSS ON DRYING | ≤1.00% | Ph. Eur. / EP |
| RESIDUE ON IGNITION | ≤0.1% | Ph. Eur. / EP |
| OPTICAL ROTATION | +89.0º a +93.0º | Ph. Eur. – USP / EP-USP |
| RESIDUAL SOLVENTS | ||
| Toluene | ≤890 ppm | USP |
| Ethanol | ≤5 000 ppm | |
| SOLUTION APPEARANCE | Clear and colorless | Internal Method |
| RELATIONED SUBSTANCES | ||
| Individual Impurities | ≤1.00% | USP |
| Total Impurities | ≤2.00% | USP |
| PARTICLE SIZE | 100% through 300 mesh | Internal Method |
| SOLUBILITY | Slightly soluble in water and ethanol, practically insoluble in acetone and soluble in dilute alkaline solutions |
Metals
Pollutants
Standard
Method
| HEAVY METALS | ≤10 ppm | USP |
| LEAD | <2 ppm | USP |
| CADMIUM | <1 ppm | USP |
| ARSENIC | <1 ppm | USP |
| MERCURY | <0.1 ppm | USP |
Microbiological analysis
Specifications
Standard
Method
| TOTAL PLATE COUNT | <100 ufc/g | USP |
| YEAST AND MOULD | <100 ufc/g | USP |
| E.COLI | Negative | USP |
| SALMONELLA | Negative | USP |
| S. AUREUS | Negative | USP |
Other informations
Food grade product conforms to the Reg. (EC) No 178/2002.
Product Suitable for Vegans and Vegetarians.
Product with Halal and Kosher Certificates.
Free GMO product conforms to the Dir. CE 1829/2003 & 1830/2003.
Free Allergens product conforms to the Reg. (EU) Nº 1169/2011.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
NON Irradiated product conforms to the (EU) Dir. Nº 1999/2/CE.
Residual Solvent free product conforms to the Dir. 2009/32/EC. OVI meets / Residual solvents required. ICH, USP, EP:
Class I: Solvents not used in manufacturing processes.
Class II: Solvents used in manufacturing processes. Toluene <890 ppm
Class III: Solvents used in manufacturing processes. Alcohol <5000 ppm.
Free Pesticides conforms to the (EU) Reg. Nº 396/2005.
Free Contaminants product conforms to the Reg. (EC) No 2023/915.
Free Mycotoxins, Aflatoxins, Dioxins, Furans, PCB´s, Formaldehyde and Melamine product.
Free PAH´s and Benzopyrenes.
Free Nanomaterials product conforms to the Reg. (EU) No 1169/2011.
Free Dopants Substances product conforms to the WADA List.
SHELF LIFE: 3 years.
STORAGE: Keep in hermetically sealed containers. Protect from light and moisture. Store at <15ºC. If kept in the refrigerator at a temperature of 5-7ºC, its durability is extended.
Norms: Complies manufacturer´s specifications, USP and Eu. Ph.
Product Suitable for Vegans and Vegetarians.
Product with Halal and Kosher Certificates.
Free GMO product conforms to the Dir. CE 1829/2003 & 1830/2003.
Free Allergens product conforms to the Reg. (EU) Nº 1169/2011.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
NON Irradiated product conforms to the (EU) Dir. Nº 1999/2/CE.
Residual Solvent free product conforms to the Dir. 2009/32/EC. OVI meets / Residual solvents required. ICH, USP, EP:
Class I: Solvents not used in manufacturing processes.
Class II: Solvents used in manufacturing processes. Toluene <890 ppm
Class III: Solvents used in manufacturing processes. Alcohol <5000 ppm.
Free Pesticides conforms to the (EU) Reg. Nº 396/2005.
Free Contaminants product conforms to the Reg. (EC) No 2023/915.
Free Mycotoxins, Aflatoxins, Dioxins, Furans, PCB´s, Formaldehyde and Melamine product.
Free PAH´s and Benzopyrenes.
Free Nanomaterials product conforms to the Reg. (EU) No 1169/2011.
Free Dopants Substances product conforms to the WADA List.
SHELF LIFE: 3 years.
STORAGE: Keep in hermetically sealed containers. Protect from light and moisture. Store at <15ºC. If kept in the refrigerator at a temperature of 5-7ºC, its durability is extended.
Norms: Complies manufacturer´s specifications, USP and Eu. Ph.
*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.
