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VITAMIN B5 POWDER

From 1 Kg
Producto Nutrifoods

Technical data sheet

Reference Nº: VIT-015
Review: 6
Date: 01/08/2023
VITAMIN B5 POWDER
CAS Nº
0137-08-06
EC/EINECS Nº
205-278-9
OTHER NAMEVITAMIN B5 (CALCIUM D-PANTOTHENATE)
MOLECULAR FORMULAC18H32CaN2O10
MOLECULAR WEIGHT476.54 g/mol
GEOGRAPHICAL ORIGINEurope
ORIGENSynthetic
Specifications
Standard
Method
APPEARANCEFine, white free flowing granulateVisual
ODOURCharacteristicOlfactory
TASTECharacteristicGustatory
IDENTIFICATION
IdentifiationPositivePh. Eur / EP – USP
Test A (TLC)PositiveIP
Test B (colourimetry, ferric chloride)PositiveIP
Test C (colourimetry, copper sulfate)PositiveIP
Test D (calcium)PositiveIP
SOLUTION APPEARANCEConformsPh. Eur / EP
CHLORIDE≤200ppmPh. Eur / EP
ALKALINITYConformsUSP
ALKALOIDSConformsFCC
LOSS ON DRYING≤3.0 %Internal Method
pH6.8 – 8.0Internal Method
BULK DESINTYAprox. 0.6 g/mlInternal Method
OPTICAL ROTATION+25.50º a +27.50ºPh. Eur / EP – IP
RELATED SUBSTANCES (TLC)
Beta-Alanine≤0.5 %Internal Method
RELATED SUBSTANCES (HPLC)
Pantoate≤1.0 %Internal Method
Pantolactone≤0.3 %Internal Method
Alanyl Calcium-D-Pantothenate≤0.3 %Internal Method
Any unspecified impurity≤0.1 % (each)Internal Method
Total impurities≤2.0 %Internal Method
RESIDUAL SOLVENTS≤100 ppmUSP, Ph. Eur. / USP, EP
ASSAY
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
SOLUBILITYEasily soluble in water, moderately soluble in ethanol and practicaly insoluble in ether.

Metals

Pollutants
Standard
Method
HEAVY METALS≤10 ppmPh. Eur. / EP
ARSENIC≤1 ppmInternal Method
LEAD≤1 ppmInternal Method
CADMIUM≤1 ppmInternal Method
MERCURY≤0.1 ppmInternal Method

Microbiological analysis

Specifications
Standard
Method
TOTAL PLATE COUNT≤1000 ufc/gPh. Eur. / EP – USP
YEASTS AND MOULD≤100 ufc/gPh. Eur. / EP – USP
BILE TOLERANTE GRAMNEG. BACTERIA≤100 ufc/g
E. COLIAbsence/gPh. Eur. / EP – USP
SALMONELLAAbsence/10gPh. Eur. / EP – USP
S. AUREUSAbsence/gPh. Eur. / EP – USP

Other informations

USE: Food.
Product Suitable for Vegans and Vegetarians.
Product with Halal and Kosher Certificate.
Free GMO product conforms to the Reg. CE 1829/2003 & 1830/2003.
Free Allergens product conforms to the Reg. (EU) Nº 1169/2011 and USP Food Allergen Labeling and Consumer Protection act (FALCPA).
Free BSE/TSE product conforms to the Reg. (EC) 999/2001 as amended.
Free Pesticides conforms to the (EU) Reg. Nº 396/2005.
Free Contaminants product conforms to the Reg. (EC) No 2023/915.
Free Residual Solvents product conforms to the EP and USP. Only Class 2 solvent methanol is likely to be present. Residual Class 2 solvent is below the Option 1 limit. No other solvents, not listed in the above-mentioned guidelines or monographs are likely to be present.
Free PAH’s product.
Free Melamine product.
Free Aflatoxins product.
Product is NOT irradiated.
Compliance statement reg. 1935/2004 and 10/2011 regarding packaging materials in contact with food.
SHELF LIFE: 3 Years.
STORAGE: Keep in tightly closed containers, store in a cool, dark place, away from light.
Norms: Complies manufacturer´s specifications, USP, FCC, EP, CFR, GRAS and IP.
*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.