Biotin powder
From 5 gr
From 5 gr
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PRODUCT INFORMATION
TECNICAL DATA SHEET |
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REFERENCE Nº: VIT-035 |
REVIEW: 8 |
DATE: 02.2022 |
PRODUCT NAME |
VITAMIN H (D-BIOTIN) |
|
MOLECULAR FORMULA |
C10H16N2O3S |
|
MOLECULAR WEIGHT |
244.3 g/mol |
|
CAS Nº |
58-85-5 |
|
EINECS Nº |
200-399-3 |
|
ORIGIN |
Sinthetic |
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GEOGRAPHICAL ORIGIN |
Asia |
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PHYSICAL AND CHEMICAL ASSAY |
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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 |
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Toluene |
≤890 ppm |
USP |
Ethanol |
≤5 000 ppm |
|
SOLUTION APPEARANCE |
Clear and colorless |
Internal Method |
RELATIONED SUBSTANCES |
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Individual Impurities |
≤1.00% |
USP |
Total Impurities |
≤2.00% |
USP |
PARTICLE SIZE |
100% pasa / through 300 mesh |
Internal Method |
SOLUBILITY |
Slightly soluble in water and ethanol, practically insoluble in acetone and soluble in dilute alkaline solutions |
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SPECIFICATIONS |
STANDARD |
METHOD |
HEAVY METALS |
≤10 ppm |
USP |
LEAD |
<2 ppm |
USP |
CADMIUM |
<1 ppm |
USP |
ARSENIC |
<1 ppm |
USP |
MERCURY |
<0.1 ppm |
USP |
PHYSICAL AND CHEMICAL ASSAY |
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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 |
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Food grade product conforms to the Reg. (EC) No 178/2002. |
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Product Suitable for Vegans and Vegetarians. |
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Product with Halal and Kosher Certificates. |
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Free GMO product conforms to the Dir. CE 1829/2003 & 1830/2003. |
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Free Allergens product conforms to the Reg. (EU) Nº 1169/2011. |
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Free BSE/TSE product conforms to the Reg. (EC) No 999/2001. |
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NON Irradiated product conforms to the (EU) Dir. Nº 1999/2/CE. |
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Residual Solvent free product conforms to the Dir. 2009/32/EC. OVI meets / Residual solvents required. ICH, USP, EP: |
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Class I: Solvents not used in manufacturing processes. |
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Class II: Solvents used in manufacturing processes. Toluene <890 ppm |
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Class III: Solvents used in manufacturing processes. Alcohol <5000 ppm. |
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Free Pesticides conforms to the (EU) Reg. Nº 396/2005. |
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Free Contaminants product conforms to the Reg. No 1881/2006 and No 629/2008. |
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Free Mycotoxins, Aflatoxins, Dioxins, Furans, PCB´s, Formaldehyde and Melamine product. |
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Free PAH´s and Benzopyrenes. |
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Free Nanomaterials product conforms to the Reg. (EU) No 1169/2011. |
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Free Dopants Substances product conforms to the WADA List. |
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SHELF LIFE: 3 years. |
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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. |
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Norms: Complies manufacturer´s specifications, USP and Eu. Ph. |
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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 INTENTED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE. |