JRS PHARMA VIVAPHARM® HPMC
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VIVAPHARM® HPMC is Hypromellose / Hydroxypropylmethylcellulose manufactured from wood-derived cellulose pulp and available in multiple viscosity grades, including E3, E5, E6, E15, and E50.
Manufactured from wood-derived cellulose pulp.- Plant-origin material with no animal-origin contact during manufacturing or packaging.
- Complies with NF, Ph. Eur., and JP monographs for Hypromellose.
- Suitable for vegan and ovo-lacto-vegetarian applications.
- Recommended re-evaluation period of 3 years when stored as recommended.
Shows maximum heavy metal levels for VIVAPHARM® HPMC.
| Heavy Metals | |
|---|---|
| Heavy Metal | Maximum Level |
| Arsenic | NMT 3 mg/kg |
| Cadmium | NMT 1 mg/kg |
| Lead | NMT 2 mg/kg |
| Mercury | NMT 1 mg/kg |
Shows what the material is made from and its plant-based origin.
Composition and Origin
VIVAPHARM® HPMC is pure Hydroxypropyl Methylcellulose manufactured from cellulose pulp obtained from wood. The main raw material is plant-origin cellulose pulp, while other raw materials are synthetic. No animal-origin materials or animal-based processing aids are used during manufacturing or packaging.
Shows the specification limits and test references for the VIVAPHARM® HPMC grades.
| Technical Specifications | |||||
|---|---|---|---|---|---|
| VIVAPHARM® HPMC E3 | |||||
| Characteristics | Specification | Reference | |||
| Loss on drying (105° 1 h) | max. 5.0 % | USP, Ph. Eur.,JP | |||
| Apparent viscosity (Ubbelohde) | 2.4 – 3.6 mPa∙s | USP, Ph. Eur.,JP | |||
| Methoxy content | 28.0 – 30.0 % | USP, Ph. Eur.,JP | |||
| Hydroxypropoxy content | 7.0 – 12.0 % | USP, Ph. Eur.,JP | |||
| Identification (A,B,C,D,E)(1,2,3,4,5) | passes | USP, Ph. Eur.,JP | |||
| Appearance of solution | passes | Ph. Eur. | |||
| pH | 5.0- 8.0 | USP, Ph. Eur., JP | |||
| Residue on ignition (Sulfated ash) | max. 1.5 % | USP, Ph. Eur., JP | |||
| Heavy metals | max. 20 ppm | JP (monitored) 1 | |||
| VIVAPHARM® HPMC E5 | |||||
| Characteristics | Specification | Reference | |||
| Loss on drying (105° 1 h) | max. 5.0 % | USP, Ph. Eur.,JP | |||
| Apparent viscosity (Ubbelohde) | 4.0 – 6.0 mPa∙s | USP, Ph. Eur.,JP | |||
| Methoxy content | 28.0 – 30.0 % | USP, Ph. Eur.,JP | |||
| Hydroxypropoxy content | 7.0 – 12.0 % | USP, Ph. Eur.,JP | |||
| Identification (A,B,C,D,E)(1,2,3,4,5) | passes | USP, Ph. Eur.,JP | |||
| Appearance of solution | passes | Ph. Eur. | |||
| pH | 5.0- 8.0 | USP, Ph. Eur., JP | |||
| Residue on ignition (Sulfated ash) | max. 1.5 % | USP, Ph. Eur., JP | |||
| Heavy metals | max. 20 ppm | JP (monitored) 1 | |||
| VIVAPHARM® HPMC E6 | |||||
| Characteristics | Specification | Reference | |||
| Loss on drying (105° 1 h) | max. 5.0 % | USP, Ph. Eur.,JP | |||
| Apparent viscosity (Ubbelohde) | 4.8 – 7.2 mPa∙s | USP, Ph. Eur.,JP | |||
| Methoxy content | 28.0 – 30.0 % | USP, Ph. Eur.,JP | |||
| Hydroxypropoxy content | 7.0 – 12.0 % | USP, Ph. Eur.,JP | |||
| Identification (A,B,C,D,E)(1,2,3,4,5) | passes | USP, Ph. Eur.,JP | |||
| Appearance of solution | passes | Ph. Eur. | |||
| pH | 5.0- 8.0 | USP, Ph. Eur., JP | |||
| Residue on ignition (Sulfated ash) | max. 1.5 % | USP, Ph. Eur., JP | |||
| Heavy metals | max. 20 ppm | JP (monitored) 1 | |||
| VIVAPHARM® HPMC E15 | |||||
| Characteristics | Specification | Reference | |||
| Loss on drying (105° 1 h) | max. 5.0 % | USP, Ph. Eur.,JP | |||
| Apparent viscosity (Ubbelohde) | 12.0 – 18.0 mPa∙s | USP, Ph. Eur.,JP | |||
| Methoxy content | 28.0 – 30.0 % | USP, Ph. Eur.,JP | |||
| Hydroxypropoxy content | 7.0 – 12.0 % | USP, Ph. Eur.,JP | |||
| Identification (A,B,C,D,E)(1,2,3,4,5) | passes | USP, Ph. Eur.,JP | |||
| Appearance of solution | passes | Ph. Eur. | |||
| pH | 5.0- 8.0 | USP, Ph. Eur., JP | |||
| Residue on ignition (Sulfated ash) | max. 1.5 % | USP, Ph. Eur., JP | |||
| Heavy metals | max. 20 ppm | JP (monitored) 1 | |||
| VIVAPHARM® HPMC E50 | |||||
| Characteristics | Specification | Reference | |||
| Loss on drying (105° 1 h) | max. 5.0 % | USP, Ph. Eur.,JP | |||
| Apparent viscosity (Ubbelohde) | 40.0 – 60.0 mPa∙s | USP, Ph. Eur.,JP | |||
| Methoxy content | 28.0 – 30.0 % | USP, Ph. Eur.,JP | |||
| Hydroxypropoxy content | 7.0 – 12.0 % | USP, Ph. Eur.,JP | |||
| Identification (A,B,C,D,E)(1,2,3,4,5) | passes | USP, Ph. Eur.,JP | |||
| Appearance of solution | passes | Ph. Eur. | |||
| pH | 5.0- 8.0 | USP, Ph. Eur., JP | |||
| Residue on ignition (Sulfated ash) | max. 1.5 % | USP, Ph. Eur., JP | |||
| Heavy metals | max. 20 ppm | JP (monitored) 1 | |||
Shows EU and US-format nutritional values per 100 g.
| Nutritional Profile | |
|---|---|
| EU Regulation | Values per 100g |
| Calorific value | 196 kcal or 784 kJ / 100g *3 |
| Protein | 0.0 g |
| Usable carbohydrate*2 | 0.0 g |
| Sucrose | 0.0 g |
| Glucose | 0.0 g |
| Fructose | 0.0 g |
| Fat | 0.0 g |
| Saturated fatty acids | 0.0 g |
| Unsaturated fatty acids | 0.0 g |
| Dietary fiber*4 | 98 g |
| Sodium | 1.788g |
| *2 | Calculated |
| *3 | Within the European Union due to directive 2008/100/EC dietary fibers have to be calculated with 2 kcal/g - 8 kJ/g. From 31st October 2012 no trade is allowed with products which do not comply with this directive. |
| *4 | The dietary fiber content in the dried matter is min 94 %. |
| US Regulation | Avg. Units per 100 g |
| Carbohydrates | 93.5% |
| Carbohydrates, Available | 0.0% |
| Calories | 187 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 | <1.00 mg/100 g |
| Iron | <1.00 mg/100 g |
| Sodium | <3.00 mg/100 g |
| Potassium | <3.00 mg/100 g |
| Ash | 1.5% |
| Moisture | 5.0% |
| Total Fat | 0.00% |
| Saturated Fat | 0.00% |
| Monounsaturated Fat | 0.00% |
| cis-cis Polyunsaturated Fat | 0.00% |
| trans Fat | 0.00% |
| Protein | 0.00% |
| Insoluble Fiber | 99.9% |
| Soluble Fiber | <0.2% |
| Total Fiber | 99.9% |
| Fructose | Less than 0.1% |
| Glucose | Less than 0.1% |
| Sucrose | Less than 0.1% |
| Maltose | Less than 0.1% |
| Total Sugars | 0.00% |
Storage stability and protective storage conditions for maintaining product quality.
How should this product be stored to maintain stability?
Storage stability statement explicitly stated for VIVAPHARM® HPMC.
What is the stated storage stability period?
years
What protective measures are required during storage?
kept in original unopened containers protected from heat and moisture
Shows the main formal regulatory, compendial, food, and registration references.
| Regulatory Compliance | |
|---|---|
| Area | Status |
| NF | Complies with Hypromellose monograph |
| Ph. Eur. | Complies with Hypromellose monograph |
| JP | Complies with Hypromellose monograph |
| E464(i) | EU approved food additive |
| FCC | Complies with FCC monograph for Hydroxypropylmethylcellulose |
| GRAS | Listed as GRAS under 21 CFR 172.874 |
| CEP | R1-CEP 2007-321-Rev 01 for Microcellulose Weissenborn |
| REACH | Medicinal-use excipient status understood under Article 2.5(a) exemption |
Allergen information table showing allergen names and presence status for VIVAPHARM HPMC.
| 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 |
| Chicken meat | Absent |
| Sesame | Absent |
| Lactose | Absent |
| Fish | Absent |
| Sesame oil | Absent |
| Egg | Absent |
| Crustaceans | Absent |
| Glutamate (E620 - E625) | Absent |
| Soy | Absent |
| Corn / maize | Absent |
| Sulpher dioxide and sulphites (E220 – E228) at concentrations of more than 10 mg/kg or 10 mg/l, expressed as SO2 | Absent |
Shows the recommended storage conditions and re-evaluation handling for VIVAPHARM® HPMC.
Storage and Handling
- Store in original, unopened, well-closed containers.
- Protect from excessive heat and moisture.
- Store under dry and ambient conditions.
- Inner bags should be sealed and cartons tightly secured when the entire contents are not used.
- Recommended re-evaluation period is 3 years from the date of manufacture.
- One additional year may be added after re-evaluation if loss on drying, pH, and viscosity remain within specification.
- Expiration date has not been determined.