VIVASOL® GF / GF LM - JRS PHARMA
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VIVASOL® GF and VIVASOL® GF LM are Croscarmellose Sodium grades produced from wood cellulose and used as pharmaceutical excipients compliant with Ph. Eur., NF, JP, and ChP.
Croscarmellose sodium excipient available as VIVASOL® GF and VIVASOL® GF LM.- Plant-origin material with no animal-origin contact during manufacturing or packaging.
- Complies with Ph. Eur., NF, JP, and ChP monographs for Croscarmellose Sodium.
- Common EU/FALCPA allergens are absent, including gluten, milk/lactose, soy, nuts, sesame, and sulphites above threshold.
- Suitable for vegan and ovo-lacto-vegetarian applications.
- Recommended re-evaluation period: 4 years for VIVASOL® GF and 2 years for VIVASOL® GF LM.
Shows common EU/FALCPA allergens as absent.
| Allergen Information | |
|---|---|
| Allergen (Regulation (EC) No 1169/2011, Annex II as amended) (FALCPA for USA) | Status |
| 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 |
| Sulphur 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 |
Shows EU and US-format nutritional values per 100 g.
| Nutritional Values | |
|---|---|
| Nutritional Values EU | Value per 100 g |
| Calorific value | ~ 179 kcal or 716 kJ |
| Protein | < 0.1 g |
| Usable carbohydrate | < 0.1 g |
| Sucrose | < 0.1 g |
| Glucose | < 0.1 g |
| Fructose | < 0.1 g |
| Fat | < 0.1 g |
| Saturated fatty acids | < 0.1 g |
| Unsaturated fatty acids | < 0.1 g |
| Dietary fiber | ~ 89.5 g |
| Nutritional Values EU | Avg. Units per 100 g |
| Carbohydrates | 89.0% |
| Carbohydrates, Available | 0.0% |
| Calories | 178 Calories/100 g |
| Calories from Fat | 0 Calories/100 g |
| Calories from Saturated Fat | 0 Calories/100 g |
| Calories (Insoluble Fiber Subtracted) | 0 Calories/100 g |
| Calcium | 0.003 % |
| Iron | 0.0006 % |
| Sodium | 5.98 % |
| Potassium | 0.017 % |
| Ash | 13.914 % |
| Moisture | 7.924 % |
| Total Fat | 0.0 % |
| Saturated Fat | 0.0 % |
| Monounsaturated Fat | 0.0 % |
| cis-cis Polyunsaturated Fat | 0.0 % |
| trans Fat | 0.0 % |
| Protein | < 0.781 % |
| Insoluble Fiber | 89.0% |
| Soluble Fiber | 0.0 % |
| Total Fiber | 89.0% |
| Dietary Fiber | 0.0 % |
| Fructose | < 0.1% |
| Glucose | < 0.1% |
| Sucrose | < 0.1% |
| Maltose | < 0.1% |
| Total Sugars | 0.0 % |
Shows what the product is made from and the origin of its raw materials.
Composition and Origin
VIVASOL® GF and VIVASOL® GF LM are pure Croscarmellose Sodium products manufactured from wood cellulose. Process aids are synthetic in origin and include sodium hydroxide, acetic acid and derivatives, and ethanol. The products have no animal-origin contact during manufacturing or packaging.
Technical specifications table showing chemical, microbiological, and physical quality parameters with limits and methods for VIVASOL® GF LM.
| Technical Specifications | ||
|---|---|---|
| Chemical Specifications | Acceptance Criteria | Reference |
| Identification (A, B, C), (1, 2, 3) | Passes | Ph. Eur., NF, JP |
| Content of water-soluble material | 1.0 – 10.0 % | Ph. Eur., NF, JP |
| Degree of substitution | 0.60 – 0.85 | Ph. Eur., NF, JP |
| Loss on drying | Max. 6.0 % | Ph. Eur., NF, JP |
| pH | 5.0 – 7.0 | Ph. Eur., USP, JP |
| Residue of ethanol | Max. 0.1 % | JRS Method |
| Sodium chloride and sodium glycolate | Max. 0.5 % | Ph. Eur., NF, JP |
| Sodium content | Max. 12.4 % | JRS Method |
| Sulphated ash | 14.0 – 28.0 % | Ph. Eur., NF, JP |
| Arsenic | Max. 2 ppm | JRS Method |
| Cadmium | Max. 1 ppm | JRS Method |
| Heavy metals | Max.10 ppm | JRS Method |
| Lead | Max. 2 ppm | JRS Method |
| Mercury | Max. 1 ppm | JRS Method |
| TAMC (Total aerobic microbial count) | 102 CFU/g | Ph. Eur., USP,JP |
| TYMC (Total yeast and mold count) | 20 CFU/g | Ph. Eur., USP,JP |
| E. 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 |
| Settling volume | 10.0 – 30.0 ml | Ph. Eur., NF, JP |
| Particle size distribution (laser diffraction) | ||
| d10 | Max. 25 µm | JRS Method |
| d50 | 25 – 55 µm | JRS Method |
| d90 | Min. 60 µm | JRS Method |
Technical specifications table showing chemical, physical, and microbiological parameters with acceptance criteria and reference methods.
| Technical Specifications | ||
|---|---|---|
| Parameter | Acceptance Criteria | Reference Method |
| Identification (A, B, C), (1, 2, 3) | Passes | Ph. Eur., NF, JP |
| Arsenic | Max. 2 ppm | JRS Method |
| Content of water-soluble material | 1.0 – 10.0 % | Ph. Eur., NF, JP |
| Degree of Substitution | 0.60 – 0.85 | Ph. Eur., NF, JP |
| Heavy metals | Max.10 ppm | JRS Method |
| Loss on drying | Max. 10.0 % | Ph. Eur., NF, JP |
| pH | 5.0 - 7.0 | Ph. Eur., USP, JP |
| Residue of Ethanol | Max. 0.5 % | JRS Method |
| Sodium chloride and Sodium glycolate | Max. 0.5 % | Ph. Eur., NF, JP |
| Sulphated ash | 14.0 – 28.0 % | Ph. Eur., NF, JP |
| TAMC (Total Aerobic Microbial Count) | 10² cfu/ g | Ph. Eur., USP, JP |
| TYMC (Total Yeast and Mold Count) | 20 cfu/ g | Ph. Eur., USP, JP |
| E. 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 |
| Settling volume | 10.0 – 30.0 ml | Ph. Eur., NF, JP |
| Particle Size distribution (laser diffraction) | ||
| d10 | Max. 25 µm | JRS Method |
| d50 | 25 – 55 µm | JRS Method |
| d90 | Min. 60 µm | JRS Method |
Storage guidance and re-evaluation timing for the product.
Which grades are available?
The available grades in the provided documents are VIVASOL® GF and VIVASOL® GF LM.
What is the difference between GF and GF LM?
GF LM is the lower-moisture grade. It has a lower loss on drying limit and a lower ethanol limit than GF.
What compendial standards are referenced?
VIVASOL® GF and GF LM are referenced against Ph. Eur., NF, and JP.
What is the re-evaluation period?
VIVASOL® GF has a recommended re-evaluation period of 4 years. VIVASOL® GF LM has a recommended re-evaluation period of 2 years.
Which pharmacopoeias are covered?
The product is covered by Ph. Eur., NF, JP, and ChP references for Croscarmellose Sodium.
Shows storage conditions and re-evaluation handling for the VIVASOL® GF grades.
Storage and Handling
- Store in original, unopened, well-closed containers.
- Protect from excessive heat and moisture.
- Inner bags should be sealed and cartons tightly secured when the entire contents are not used.
- VIVASOL® GF has a recommended re-evaluation period of 4 years from the date of manufacture.
- VIVASOL® GF LM has a recommended re-evaluation period of 2 years from the date of manufacture.
- After re-evaluation, one additional year may be added for VIVASOL® GF if loss on drying remains within specification.
- After re-evaluation, half a year may be added for VIVASOL® GF LM if loss on drying remains within specification.