Technical data sheet
Reference Nº: VIT-035/2
Review: 9
Date: 01/09/2023
VITAMIN H (D-BIOTIN)
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.
*The organoleptic characteristics of dried extracts may change from batch due to the vegetal origin of the raw material used for processing, the date of harvest, the processing area or the climate during the crop, not affecting in any case to the properties neither to the quality of the extract. (Colour, Smell, Taste, Humidity, and so on...)
*The technical data sheets are informative and may not be up-to-date. Please contact us for the latest version.
*The organoleptic characteristics of dried extracts may change from batch due to the vegetal origin of the raw material used for processing, the date of harvest, the processing area or the climate during the crop, not affecting in any case to the properties neither to the quality of the extract. (Colour, Smell, Taste, Humidity, and so on...)
*The technical data sheets are informative and may not be up-to-date. Please contact us for the latest version.
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