Technical data sheet
N° de référence VIT-015F
Date : 01/02/2025
VITAMINE B5_D-PANTOTHÉNATE CALCIQUE
N° CAS
137-08-6
Nº EC/EINECS
205-278-9
| CHEMICAL IDENTIFICATION | |
| MOLECULAR FORMULA | C18H32CaN2O10 |
| MOLECULAR WEIGHT | 476.54 g/mol |
| GEOGRAPHICAL ORIGIN | Europa |
| ORIGEN | Synthetic |
| CATEGORY | Nutritional additives a. Vitaminas / Vitamins. |
| CODE | 3a841 |
| SPECIES or CATEGORIES of ANIMAL | All animal species |
| APPEARANCE | Fine, white free flowing granulate |
| ODOUR | Characteristic |
| TASTE | Characteristic |
Spécifications
Standard
Méthode
| IDENTIFICACIÓN / IDENTIFICATION | ||
| Identifiation | Complies | USP |
| Specific optical rotation | Complies | EP |
| Calcium | Complies | EP |
| SOLUTION APPEARANCE | Clear and colorless | EP |
| CHLORIDE | ≤200 ppm | EP |
| ALKALINITY | Complies | USP |
| ALKALOIDS | Complies | FCC |
| LOSS ON DRYING | ≤3.0 % | USP |
| pH | 6.8 – 8.0 | EP |
| BULK DESINTY | aprox./ approx. 0.6 g/ml | Internal Method |
| OPTICAL ROTATION at 20ºC, calculated on dried basis | +25.50º a +27.50º | EP |
| SUSTANCIAS RELACIONADAS / RELATED SUBSTANCES | ||
| Impurity A (Beta-Alanine) and other aminocarboxylic impurities | ≤0.5 % | USP |
| Pantoic acid | ≤1.0 % | USP |
| Pantolactone | ≤0.5 % | USP |
| ß-alanyl pantothenamide | ≤0.25 % | USP |
| Any unspecified impurity | each) | USP |
| Total impurities | ≤1.5 % | USP |
| RESIDUAL SOLVENTS: Methanol | ≤100 ppm | Internal Method |
| RIQUEZA / 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% | Stoichiometric calculation |
| SOLUBILITY | Easily soluble in water, moderately soluble in ethanol and practicaly insoluble in ether. | Internal Method |
Métaux
Polluants
Standard
Méthode
| ARSENIC | ≤1 ppm | Internal Method |
| LEAD | ≤0.5 ppm | Internal Method |
| CADMIUM | ≤0.5 ppm | Internal Method |
| MERCURY | ≤0.1 ppm | Internal Method |
Microbiological assay
Spécifications
Standard
Méthode
| TOTAL PLATE COUNT | ≤1000 ufc/g | EP – USP |
| YEASTS AND MOULD | ≤100 ufc/g | EP – USP |
| BILE TOLERANTE GRAMNEG. BACTERIA | ≤100 ufc/g | EP – USP |
| E. COLI | Ausencia/g – Absence/g | EP – USP |
| SALMONELLA | Ausencia/10g – Absence/10g | EP – USP |
| S. AUREUS | Ausencia/g – Absence/g | EP – USP |
Autres informations
Use: Additives for animal feed.
Product according to the Reg. (EC) No 1831/2003.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Allergens Free Product conforms to the Reg. (EU) No 1169/2011.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
Free Contaminants product conforms to the Reg. (EC) No 2023/915.
Free Pesticides product conforms to the Reg. (CE) No 396/2005.
Nanomaterials Free Product conforms to the Reg. (EU) No 1169/2011.
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 liested in the above mentioned guidelin or monographs are likely to be present.
Producto NO ha sido Irradiado according to the Dir. (EU) 1999/3CE.
Dopants Substances Free product conforms to the WADA List.
STORAGE: Store in tightly closed containers, in a cool, dark place, away from light.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications, USP, FCC, EP, CFR, GRAS and IP.
For the indicated regulations and directives, subsequent modifications are included.
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 INTENDED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE.
STORAGE CONDITIONS
Product according to the Reg. (EC) No 1831/2003.
GMO Free Product conforms to the Reg. (EC) No 1829/2003 & No 1830/2003.
Allergens Free Product conforms to the Reg. (EU) No 1169/2011.
Free BSE/TSE product conforms to the Reg. (EC) No 999/2001.
Free Contaminants product conforms to the Reg. (EC) No 2023/915.
Free Pesticides product conforms to the Reg. (CE) No 396/2005.
Nanomaterials Free Product conforms to the Reg. (EU) No 1169/2011.
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 liested in the above mentioned guidelin or monographs are likely to be present.
Producto NO ha sido Irradiado according to the Dir. (EU) 1999/3CE.
Dopants Substances Free product conforms to the WADA List.
STORAGE: Store in tightly closed containers, in a cool, dark place, away from light.
Shelf life: 3 years.
Norms: Complies manufacturer´s specifications, USP, FCC, EP, CFR, GRAS and IP.
For the indicated regulations and directives, subsequent modifications are included.
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 INTENDED USE. THIS DOCUMENT IS GENERATED BY COMPUTER AND IS VALID WITHOUT SIGNATURE.
STORAGE CONDITIONS
*Les caractéristiques du produit peuvent présenter des variations d’un lot à l’autre en raison de l’origine des matières premières utilisées dans sa fabrication, de leur zone de provenance ou de facteurs naturels qui leur sont associés. Ces variations peuvent affecter des paramètres tels que la couleur, l’odeur, le goût ou l’humidité, sans compromettre en aucun cas ses propriétés ni sa qualité.
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