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 NAME | VITAMIN B5 (CALCIUM D-PANTOTHENATE) |
| MOLECULAR FORMULA | C18H32CaN2O10 |
| MOLECULAR WEIGHT | 476.54 g/mol |
| GEOGRAPHICAL ORIGIN | Europe |
| ORIGEN | Synthetic |
Specifications
Standard
Method
| APPEARANCE | Fine, white free flowing granulate | Visual |
| ODOUR | Characteristic | Olfactory |
| TASTE | Characteristic | Gustatory |
| IDENTIFICATION | ||
| 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) | ||
| 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 ppm | USP, 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 |
| SOLUBILITY | Easily soluble in water, moderately soluble in ethanol and practicaly insoluble in ether. |
Metals
Pollutants
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 analysis
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
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.
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.
*Product characteristics may vary from one batch to another due to the origin of the raw materials used in its manufacture, their area of origin, or natural factors associated with them. These variations may affect parameters such as color, odor, taste, or moisture, without compromising its properties or quality.
*The technical data sheets are informative and may not be up-to-date. Please contact us for the latest version.
*Any additional information or supporting documentation will be provided upon request or against order.
All the raw materials we sell are strictly tested.
In our own quality laboratory in Spain.
Constant
stock rotation.
stock rotation.
To guarantee fresh batches at all times.
Punctuality and quality of delivery.
We deliver how, when and where you need it.
All our products are labeled and have their own documentation in English and Spanish.
Ask us whatever you might need; we’ll take care of it.
At Nutrifoods we are distributors of raw materials for the food supplement industry. We ship to more than 20 different countries all over the world, always making sure to meet the highest standards in terms of quality of customer service and guaranteed satisfaction. It’s easy to work with us.
