VIVASTAR® P - JRS PHARMA
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VIVASTAR® P is Sodium Starch Glycolate manufactured from potato starch derived from European potatoes. It is plant-origin only and does not come into contact with animal-origin materials during manufacturing or packaging.
VIVASTAR® is a sodium starch glycolate made from plant-origin potato starch derived from European potatoes.- It is documented as complying with the Ph. Eur., NF and JP monographs for Sodium Starch Glycolate.
- The product includes explicit regulatory statements such as gluten-free declaration, low pesticide levels, and defined heavy-metal limits.
VIVASTAR P is presented with ingredient profile details covering sodium starch glycolate, potato starch-derived material, and related pharmacopeial specifications with supporting visuals.
Composition and Origin
VIVASTAR® is Sodium Starch Glycolate manufactured from potato starch derived from European potatoes. The raw material is only of plant origin, and there is no contact with material of animal origin during the manufacturing and packaging process. No animal-based processing aids are used during production.
Nutritional composition table showing nutrient names and their declared minimum or maximum values per 100 g.
| Nutritional composition | |
|---|---|
| Nutrient | Avg. units per 100 g |
| Carbohydrates | 84.8 % |
| Carbohydrates, Available | 84.8% |
| Calories | 339 Calories/100 g |
| Calories from Fat | 0 Calories/100 g |
| Calories from Saturated Fat | 0 Calories/100 g |
| Calories (Insoluble Fiber Subtracted) | 339 Calories/100 g |
| Calcium | 11.3 mg/100 g |
| Iron | <1 mg/100 g |
| Sodium | 4550 mg/100 g |
| Potassium | 48.7 mg/100 g |
| Ash | 10.258 % |
| Moisture | 4.952 % |
| Total Fat | 0.00 % |
| Saturated Fat | 0.00 % |
| Monounsaturated Fat | 0.00 % |
| cis-cis Polyunsaturated Fat | 0.00 % |
| trans Fat | 0.00 % |
| Protein | < 0.781 |
| Insoluble Fiber | 0.00 % |
| Soluble Fiber | 0.00 % |
| Total Fiber | 0.00 % |
| Fructose | Less than 0.1 % |
| Glucose | Less than 0.1 % |
| Sucrose | Less than 0.1 % |
| Maltose | Less than 0.1 % |
| Lactose | Less than 0.1 % |
| Total Sugars | 0.000 % |
| The nutritional values reported are calculated based on the newest available data at the time of calculation. This information is provided for preliminary calculation only. The finished product should be analyzed for accurate labeling purposes. | |
Technical specifications table showing chemical, physical, and microbiological limits for VIVASTAR® P.
| Technical Specifications | ||||
|---|---|---|---|---|
| Parameter | Min | Max | Units | Reference |
| Identification (NF A, B, C, D) | - | - | Passes | NF |
| Identification (Ph. Eur. A, B, C, D) | - | - | Passes | Ph. Eur. |
| Identification (JP 1, 2, 3) | - | - | Passes | JP |
| Appearance of solution | - | - | Passes | Ph. Eur. |
| Assay (Na+ from Starch glycolate) | 2.8 | 4.2 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 20 | ppm | JRS Method |
| Iron | - | 20 | ppm | JRS Method |
| Loss on drying | - | 7.0 | % | Ph. Eur., NF, JP |
| pH | 5.5 | 7.5 | - | Ph. Eur., NF, JP |
| Residue of methanol | - | 3.0 | % | JRS Method |
| Sodium chloride | - | 7.0 | % | JRS Method |
| Sodium glycolate | - | 2.0 | % | Ph. Eur., NF, JP |
| TAMC (Total Aerobic Microbial Count) | - | 10² | cfu/ g | Ph. Eur., USP, JP |
| TYMC (Total Yeasts and Molds Count) | - | 10² | cfu/ g | Ph. Eur., USP, JP |
| Escherichia coli | Absent in 1 g | Ph. Eur., USP, JP | ||
| Pseudomonas aeruginosa | Absent in 1 g | Ph. Eur., USP, JP | ||
| Salmonella species | Absent in 10 g | Ph. Eur., USP, JP | ||
| Staphylococcus aureus | Absent in 1 g | Ph. Eur., USP, JP | ||
| Particle size [through 140 mesh (106 um)] | 99 | % | JRS Method | |
| Settling volume | <45 | mL/ g | Ph. Eur. | |
Allergen information table showing allergen names and presence or absence status for VIVASTAR®.
| Allergen Information | |
|---|---|
| Allergen | Status |
| The presence or absence of common food allergens or proteins derived therefrom in VIVASTAR® is indicated in the table: | |
| Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof | Absent |
| Crustaceans and products thereof | Absent |
| Eggs and products thereof | Absent |
| Fish and products thereof | Absent |
| Peanuts and products thereof | Absent |
| Soybeans and products thereof | Absent |
| Milk and products thereof (including lactose) | Absent |
| Nuts i.e. Almond (Amygdalus communis), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof | Absent |
| Celery and products thereof | Absent |
| Mustard and products thereof | Absent |
| Sesame seeds and products thereof | Absent |
| Sulphur dioxide and sulphites at concentrations of more than 10 mg / kg or 10 mg / litre expressed as SO2 | Absent |
| Lupines and products thereof | Absent |
| Molluscs and products thereof | Absent |
| Allergen (LeDa List 2.0 2011), absent (Recipe without / Does not intentionally contain): | Status |
| Milk | Absent |
| Lactose | Absent |
| Egg | Absent |
| Soy | Absent |
| Soy oil | Absent |
| Gluten | Absent |
| Wheat | Absent |
| Rye | Absent |
| Beef | Absent |
| Pork | Absent |
| Chicken meat | Absent |
| Fish | Absent |
| Crustaceans | Absent |
| Corn / maize | Absent |
| Cocoa | Absent |
| Legumes | Absent |
| Nuts | Absent |
| Nut oil | Absent |
| Peanuts | Absent |
| Peanut oil | Absent |
| Sesame | Absent |
| Sesame oil | Absent |
| Glutamate (E620 - E625) | Absent |
| Sulpher dioxide and sulphites (E220 - E228) at concentrations of more than 10 mg/kg or 10 mg/l, expressed as SO2 | Absent |
| Coriander | Absent |
| Celery | Absent |
| Carrot | Absent |
| Lupin | Absent |
| Mustard | Absent |
| Molluscs | Absent |
Storage guidance for keeping the product in original, unopened, well-closed containers protected from excessive heat and moisture.
How should VIVASTAR® be stored?
VIVASTAR® should be stored in original, unopened, well-closed containers protected from excessive heat and moisture. Inner bags should be sealed and drum or carton tightly secured when the entire contents of the package are not used.
What should I do after opening the package?
Inner bags should be sealed and drum or carton tightly secured when the entire contents of the package are not used
Regulatory compliance table showing regulation identifiers, compliance statuses, scopes, and notes for VIVASTAR®.
| Regulatory Compliance | ||
|---|---|---|
| Regulation | Status | Notes |
| REACH | Exemption applies | Considered exempt when used as an ingredient in medicinal products. |
| EMA/410/01 | Compliant | No human or animal origin material used; supports BSE/TSE safety. |
| ECHA SVHC / Candidate List | No SVHC above 0.1% | No listed substances of very high concern above the regulatory threshold. |
| California Proposition 65 | Lead monitored | Lead is tested periodically and is typically below detection limit. |
| ICH Q3C / USP <467> / Ph. Eur. 5.4 / JP 2.46 | Residual solvent controlled | No listed residual solvents expected except methanol, limited to max. 3.0%. |
| ICH Q3D / USP <233> | Elemental impurities evaluated | Elemental impurities are not intentionally added and are evaluated by ICP-MS. |
Shows the main safety status and storage conditions for handling VIVASTAR® P.
Safety and Storage
- Store in original, unopened, well-closed containers.
- Do not expose to temperatures above 50°C / 122°F.
- Protect from excessive heat and moisture.