Vitamin B5 powder
From 250 gr
From 250 gr
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PRODUCT INFORMATION
TECHNICAL DATA SHEET |
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REFERENCE Nº: VIT-015 |
REVIEW: 4 |
DATE: 11.2021 |
PRODUCT NAME |
VITAMIN B5 (CALCIUM D-PANTOTHENATE) |
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MOLECULAR FORMULA |
C18H32CaN2O10 |
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MOLECULAR WEIGHT |
476.54 g/mol |
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CAS Nº |
137-08-6 |
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EINECS Nº |
205-278-9 |
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GEOGRAPHICAL ORIGIN |
Europa |
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ORIGEN |
Synthetic |
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PHYSICAL AND CHEMICAL ASSAY |
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SPECIFICATIONS |
STANDARD |
METHOD |
APPEARANCE |
Fine, white free flowing granulate |
Visual |
ODOUR |
Characteristic |
Olfactory |
TASTE |
Characteristic |
Gustatory |
IDENTIFICATION |
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Identifiation |
Positive |
Ph. Eur / EP - USP |
Test A (TLC) |
Positive |
IP |
Test B (colourimetry, ferric chloride) |
Positive |
IP |
Test C (colourimetry, copper sulfate) |
Positive |
IP |
Test D (calcium) |
Positive |
IP |
SOLUTION APPEARANCE |
Conforms |
Ph. Eur / EP |
CHLORIDE |
≤200ppm |
Ph. Eur / EP |
ALKALINITY |
Conforms |
USP |
ALKALOIDS |
Conforms |
FCC |
LOSS ON DRYING |
≤3.0 % |
Internal Method |
pH |
6.8 - 8.0 |
Internal Method |
BULK DESINTY |
Aprox. 0.6 g/ml |
Internal Method |
OPTICAL ROTATION |
+25.50º a +27.50º |
Ph. Eur / EP - IP |
RELATED SUBSTANCES (TLC) |
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Beta-Alanine |
≤0.5 % |
Internal Method |
RELATED SUBSTANCES (HPLC) |
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Pantoate |
≤1.0 % |
Internal Method |
Pantolactone |
≤0.3 % |
Internal Method |
Alanyl Calcium-D-Pantothenate |
≤0.3 % |
Internal Method |
Any unspecified impurity |
≤0.1 % (cada una / each) |
Internal Method |
Total impurities |
≤2.0 % |
Internal Method |
RESIDUAL SOLVENTS |
≤100 ppm |
USP, Ph. Eur. / USP, EP |
ASSAY |
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Calcium-D-Pantothnate (titrimetric) |
98.0 -101.0 % |
Internal Method |
Calcium-D-Pantothenate (HPLC) |
98.0 -102.0 % |
USP |
Calcium (complexometric) |
8.20 - 8.60 % |
Internal Method |
Nitrogen (Kjeldahl) |
5.70 - 6.00 % |
Internal Method |
Panthotenic acid (expressed as assay 98.0 -101%) |
89.7 - 92.5% |
Internal Method |
SOLUBILITY |
Easily soluble in water, moderately soluble in ethanol and practicaly insoluble in ether. |
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SPECIFICATIONS |
STANDARD |
METHOD |
HEAVY METALS |
≤10 ppm |
Ph. Eur. / EP |
ARSENIC |
≤1 ppm |
Internal Method |
LEAD |
≤1 ppm |
Internal Method |
CADMIUM |
≤1 ppm |
Internal Method |
MERCURY |
≤0.1 ppm |
Internal Method |
MICROBIOLOGICAL ASSAY |
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SPECIFICATIONS |
STANDARD |
METHOD |
TOTAL PLATE COUNT |
≤1000 ufc/g |
Ph. Eur. / EP - USP |
YEASTS AND MOULD |
≤100 ufc/g |
Ph. Eur. / EP - USP |
BILE TOLERANTE GRAMNEG. BACTERIA |
≤100 ufc/g |
|
E. COLI |
Absence/g |
Ph. Eur. / EP - USP |
SALMONELLA |
Absence/10g |
Ph. Eur. / EP - USP |
S. AUREUS |
Absence/g |
Ph. Eur. / EP - USP |
OTHER INFORMATIONS |
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USE: Food. |
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Product Suitable for Vegans and Vegetarians. |
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Product with Halal and Kosher Certificate. |
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Free GMO product conforms to the Reg. CE 1829/2003 & 1830/2003. |
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Free Allergens product conforms to the Reg. (EU) Nº 1169/2011 and USP Food Allergen Labeling and Consumer Protection act (FALCPA). |
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Free BSE/TSE product conforms to the Reg. (EC) 999/2001 as amended. |
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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. (EC) No 1881/2006. |
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Free PAH's product. |
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Free Melamin product. |
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Free Aflatoxins product. |
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Product is NOT irradiated. |
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Compliance statement reg. 1935/2004 and 10/2011 regarding packaging materials in contact with food. |
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SHELF LIFE: 3 Years. |
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STORAGE: Keep in tightly closed containers, store in a cool, dark place, away from light. |
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Norms: Complies manufacturer´s specifications, USP, FCC, EP, CFR, GRAS and IP. |
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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. |