JRS VIVAPUR Grades
Sell
The product offers tightly controlled purity, microbiological, and particle-size specifications, supporting consistent performance and reliable processing.- The product is backed by detailed physical, chemical, and microbiological specifications, including particle size, bulk density, pH, and absence limits for key microorganisms.
- VIVAPUR® is a pure microcrystalline cellulose excipient made from 100% wood-derived pulp and recommended for declaration as "Microcrystalline Cellulose" or "E460 (i)".
- It carries a strong compliance profile, including EU food additive approval, Ph. Eur., NF, JP and ChP monograph compliance, GRAS status, JECFA compliance, and FDA DMF coverage.
- VIVAPUR® is backed by extensive quality and suitability assurances, with certifications and statements covering EXCiPACT, ISO 9001, FSSC 22000, halal, kosher, gluten-free status, and very low impurity levels.
- Its specification covers key physical, chemical, and microbiological parameters, including particle size, bulk density, pH, heavy metals, and the absence of specified microbes.
VIVAPUR® 101, VIVAPUR® 102, VIVAPUR® 112, VIVAPUR® 200 XLM, and Microcrystalline Cellulose entries are covered with detailed regulatory, identification, purity, microbiological, particle-size, and physical specification information.
Microcrystalline Cellulose
VIVAPUR® is pure Microcrystalline Cellulose manufactured from cellulose pulp obtained from 100% wood.
VIVAPUR® 101
Appearance: White or almost white, fine or granular, slightly hygroscopic powder. Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L)
VIVAPUR® 102
Appearance: White or almost white, fine or granular, slightly hygroscopic powder Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L)
VIVAPUR® 112
Appearance: White or almost white, fine or granular, slightly hygroscopic powder Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L)
VIVAPUR® 200 XLM
Appearance: White or almost white, fine or granular, slightly hygroscopic powder Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L)
VIVAPUR® 301
Appearance: White or almost white, fine or granular, slightly hygroscopic powder. Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L).
VIVAPUR® 302
Appearance: White or almost white, fine or granular, slightly hygroscopic powder Solubility: Practically insoluble in water, acetone, anhydrous ethanol and toluene, dilute acids and sodium hydroxide solution (50 g/ L)
Technical specifications table showing chemical and microbiological parameters with limits, units, and reference methods for VIVAPUR® 101.
| Technical Specifications | ||||
|---|---|---|---|---|
| Parameter | Min | Max | Units | Reference Method |
| Identification A, (2) | - | - | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | - | - | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | - | max. 350 | Degree of polymerization | Ph. Eur., NF, JP |
| Conductivity | - | 50 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | - | 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 10 | ppm | JRS Method |
| Loss on drying | - | 7 | % | Ph. Eur., USP, JP |
| pH | 5.0 | 7.0 | - | Ph. Eur., USP, JP |
| Solubility | - | - | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | - | 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | - | 0.24 | % | 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 |
| Escherichia coli | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | - | Absent in 1 g | - | Ph. Eur., USP, JP |
| Salmonella species | - | Absent in 0 g | g | Ph. Eur., USP, JP |
| Staphylococcus aureus | - | Absent in 1 g | - | Ph. Eur., USP, JP |
| Bulk density | 0.26 | 0.31 | g/ mL | NF, JP |
| TUP 1)Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | - | 9/ 600 cm² | cm2 | JRS Method |
| Degree of brightness | - | Conforms to JRS Standard | - | JRS Method |
| Powder flow - angle of repose | - | 45 | ° | JRS Method |
| Particle Size (retained on air jet sieve) | Min | Max | Units | Method |
| > 250 µm (60 mesh) | - | 1% | % | JRS Method |
| > 75 µm (200 mesh) | - | 30% | % | JRS Method |
| > 32 µm (450 mesh) | 50% | - | % | JRS Method |
| Particle Size (laser diffraction) | Min | Max | Units | Method |
| d10 | 15 | 30 | um | JRS Method |
| d50 | 45 | 80 | um | JRS Method |
| d90 | 100 | 180 | um | JRS Method |
Technical specifications table showing chemical and microbiological limits, methods, and units for VIVAPUR® 102.
| Technical Specifications | ||||
|---|---|---|---|---|
| Parameter | Min | Max | Units | Specification Reference |
| Identification A, (2) | - | - | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | - | - | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | - | max. 350 | Degree of polymerization | Ph. Eur., NF, JP |
| Conductivity | - | 50 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | - | 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 10 | ppm | JRS Method |
| Loss on drying | - | 7 | % | Ph. Eur., USP, JP |
| pH | 5.0 | 7.0 | - | Ph. Eur., USP, JP |
| Solubility | - | - | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | - | 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | - | 0.24 | % | 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 |
| Escherichia coli | - | 0 | in 1 g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Salmonella species | - | Absent in 10 g | g | Ph. Eur., USP, JP |
| Staphylococcus aureus | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Bulk density | 0.28 | 0.33 | g/ mL | NF, JP |
| TUP 1)Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | - | 9/ 600 | cm2 | JRS Method |
| Degree of brightness | - | - | Conforms to JRS Standard | JRS Method |
| Powder flow - angle of repose | - | 42 | ° | JRS Method |
| Particle Size (retained on air jet sieve) | Min | Max | Units | Method |
| > 250 µm (60 mesh) | - | 8% | % | JRS Method |
| > 75 µm (200 mesh) | 45% | - | % | JRS Method |
| > 32 µm (450 mesh) | 70% | - | % | JRS Method |
| Particle Size (laser diffraction) | Min | Max | Units | Method |
| d10 | 20 | 50 | µm | JRS Method |
| d50 | 90 | 150 | µm | JRS Method |
| d90 | 190 | 300 | µm | JRS Method |
Technical specifications table showing product quality parameters, limits, units, and reference methods for VIVAPUR® 301.
| Technical Specifications | ||||
|---|---|---|---|---|
| Parameter | Min | Max | Units | Reference Method |
| Identification A, (2) | - | - | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | - | - | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | - | max.350 | Degree of polymerization | Ph. Eur., NF, JP |
| Conductivity | - | 75 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | - | 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 10 | ppm | JRS Method |
| Loss on drying | - | 7.0 | % | Ph. Eur., USP, JP |
| pH | 5.0 | 7.0 | - | Ph. Eur., USP, JP |
| Solubility | - | - | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | - | 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | - | 0.24 | % | 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 |
| Escherichia coli | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Salmonella species | - | Absent in 10 g | g | Ph. Eur., USP, JP |
| Staphylococcus aureus | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Bulk density | 0.35 | 0.46 | g/ mL | NF, JP |
| TUP 1)Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | 0.35 | 9/ 600 | cm² | JRS Method |
| Particle Size (retained on air jet sieve) | Min | Max | Units | Method |
| 250 µm (60 mesh) | 1 | % | JRS Method | |
| > 75 µm (200 mesh) | 30 | % | JRS Method | |
| > 32 µm (450 mesh) | 50 | % | JRS Method | |
| Particle Size (laser diffraction) | Min | Max | Units | Method |
| d10 | 15 | 30 | µm | JRS Method |
| d50 | 45 | 80 | µm | JRS Method |
| d90 | 100 | 180 | µm | JRS Method |
Technical specifications table showing identification, physical, chemical, and microbiological limits for VIVAPUR® 302.
| Technical Specifications | ||||
|---|---|---|---|---|
| Parameter | Min | Max | Units | Reference |
| Identification A, (2) | - | - | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | - | - | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | - | 350 | Degree of polymerization | Ph. Eur., NF, JP |
| Conductivity | - | 75 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | - | 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 10 | ppm | JRS Method |
| Loss on drying | - | 7.0 | % | Ph. Eur., USP, JP |
| pH | 5.0 | 7.0 | - | Ph. Eur., USP, JP |
| Solubility | - | - | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | - | 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | - | 0.24 | % | 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 | |
| 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 | |
| Bulk density | 0.35 | 0.5 | g/ mL | NF, JP |
| Particle Size (retained on air jet sieve) | Min | Max | Units | Method |
| > 250 µm (60 mesh) | - | 8 | % | JRS Method |
| > 75 µm (200 mesh) | 45 | - | % | JRS Method |
| > 32 µm (450 mesh) | 70 | - | % | JRS Method |
| Particle Size (laser diffraction) | Min | Max | Units | Method |
| d10 | 20 | 50 | µm | JRS Method |
| d50 | 90 | 150 | µm | JRS Method |
| d90 | 190 | 300 | µm | JRS Method |
| Parameter | Min | Max | Units | Reference |
| Tapped density | 0.45 | 0.68 | µm | JRS Method |
| TUP 1) Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | - | 9/ 600 | cm² | JRS Method |
Technical specifications table showing physical, chemical, microbiological, and particle-size limits for VIVAPUR® 112.
| Technical Specifications | |||
|---|---|---|---|
| Parameter | Value | Units | Method |
| Identification A, (2) | IR scan conforms | - | Ph. Eur., NF, JP |
| Identification B, (1) | Violet-blue color | - | Ph. Eur., NF, JP |
| Identification C, (3) | Degree of polymerization max. 350 | - | Ph. Eur., NF, JP |
| Conductivity | Max. 75 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | Max. 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | Max. 10 | ppm | JRS Method |
| Loss on drying | Max. 1.5 | % | Ph. Eur., USP, JP |
| pH | 5.0 - 7.0 | - | Ph. Eur., USP, JP |
| Solubility | Dissolves completely | - | Ph. Eur. |
| Sulphated ash / residue on ignition | Max. 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | Max. 0.24 | % | 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 |
| Escherichia coli | Absent in 1 g | g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | Absent in 1 g | g | Ph. Eur., USP, JP |
| Salmonella species | Absent in 10 g | g | Ph. Eur., USP, JP |
| Staphylococcus aureus | Absent in 1 g | g | Ph. Eur., USP, JP |
| Bulk density | 0.3 | g/ mL | NF, JP |
| TUP 1) Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | Max. 9/ 600 | cm2 | JRS Method |
| Particle Size (retained on air jet sieve) | Value | United | Method |
| > 250 µm (60 mesh) | Max. 8 | % | JRS Method |
| > 75 µm (200 mesh) | Min. 45 | % | JRS Method |
| > 32 µm (450 mesh) | Min. 70 | % | JRS Method |
| Particle Size (laser diffraction) | Value | Units | Method |
| d10 | 20-50 | µm | JRS Method |
| d50 | 90-150 | µm | JRS Method |
| d90 | 190-300 | µm | JRS Method |
Technical specifications table showing nutritional parameters with minimum and maximum values and units.
| Technical Specifications | |||
|---|---|---|---|
| Parameter | Min | Max | Units |
| Calorific value | 190 | 190 | kcal or KJ /100 g |
| Protein | 0 | 0 | g |
| Usable carbohydrate*2 | 0 | 0 | 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*4 | 94 | g | |
| Sodium | 0.03 | g | |
| Carbohydrates | 96.3 | 96.3 | % |
| Carbohydrates, Available | 0 | 0 | % |
| Calories | 0 | 0 | Calories/100 g |
| Calories from Fat | 0 | 0 | Calories/100 g |
| Calories from Saturated Fat | 0 | 0 | Calories/100 g |
| Calories (Insoluble Fiber Subtracted) | 0 | 0 | Calories/100 g |
| Calcium | 1 | mg/100 g | |
| Iron | 1 | mg/100 g | |
Technical specifications table showing physical, chemical, and microbiological criteria for VIVAPUR® 200 XLM.
| Technical Specifications | ||||
|---|---|---|---|---|
| Specification | Min | Max | Units | Method |
| Identification A, (2) | - | - | IR scan conforms | Ph. Eur., NF, JP |
| Identification B, (1) | - | - | Violet-blue color | Ph. Eur., NF, JP |
| Identification C, (3) | - | 350 | Degree of polymerization | Ph. Eur., NF, JP |
| Conductivity | - | Max. 75 | µS/ cm | Ph. Eur., NF, JP |
| Ether-soluble substances | - | 0.05 | % | Ph. Eur., NF, JP |
| Heavy metals | - | 10 | ppm | JRS Method |
| Loss on drying | - | 1.5 | % | Ph. Eur., USP, JP |
| pH | 5.0 | 7.0 | - | Ph. Eur., USP, JP |
| Bulk density | 0.33 | 0.4 | g/ mL | NF, JP |
| pH | 5 | 7 | Ph. Eur., USP, JP | |
| Solubility | - | - | Dissolves completely | Ph. Eur. |
| Sulphated ash / residue on ignition | - | 0.05 | % | Ph. Eur., USP, JP |
| Water-soluble substances | - | 0.24 | % | 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 |
| Escherichia coli | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Pseudomonas aeruginosa | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Salmonella species | - | Absent in 10 g | g | Ph. Eur., USP, JP |
| Staphylococcus aureus | - | Absent in 1 g | g | Ph. Eur., USP, JP |
| Bulk density | 0.33 | 0.40 | g/ mL | NF, JP |
| TUP 1) Technically unavoidable particles according to IPEC TUPP guideline (i.e. dark particles) | 380 | 530 | µm | JRS Method |
| Particle Size (retained on air jet sieve) | Min | Max | Units | Method |
| > 400 µm (38 mesh) | - | 5 | % | JRS Method |
| > 250 µm (60 mesh) | 10 | - | % | JRS Method |
| > 150 µm (100 mesh) | 50 | - | % | JRS Method |
| Particle Size (laser diffraction) | Min | Max | Units | Method |
| d10 | 50 | 120 | µm | JRS Method |
| d50 | 180 | 280 | µm | JRS Method |
| d90 | 380 | 530 | µm | JRS Method |
Nutritional profile table showing nutrient names with minimum and maximum values and measurement units.
| Nutritional Profile | |||||
|---|---|---|---|---|---|
| EU Regulation | |||||
| Nutrient | Value | Units | |||
| Calorific value | 190 | kcal or KJ /100 g | |||
| Protein | 0 | g | |||
| Usable carbohydrate*2 | 0 | g | |||
| Sucrose | <0.1 | g | |||
| Glucose | <0.1 | g | |||
| Fructose | <0.1 | g | |||
| Fat | <0.1 | g | |||
| Unsaturated fatty acids | <0.1 | g | |||
| Saturated fatty acids | <0.1 | g | |||
| Dietary fiber*4 | >94 | g | |||
| Sodium | <0.03 | g | |||
| US Regulation | |||||
| Nutrient | Value | Units | |||
| Carbohydrates | 96.3 | % | |||
| Carbohydrates, Available | 0 | % | |||
| Calories | 0 Calories/100 g | g | |||
| Calories from Fat | 0 Calories/100 g | g | |||
| Calories from Saturated Fat | 0 Calories/100 g | g | |||
| Calories (Insoluble Fiber Subtracted) | 0 Calories/100 g | g | |||
| Calcium | <1.00 mg/100g | mg/100 g | |||
| Iron | <1.00 mg/100g | mg/100 g | |||
| Sodium | <3.00 mg/100g | mg/100 g | |||
| Potassium | <3.00 mg/100g | mg/100 g | |||
| Ash | 0.012 | % | |||
| Moisture | 3.731 | % | |||
| Total Fat | 0 | % | |||
| Saturated Fat | 0 | % | |||
| Monounsaturated Fat | 0 | % | |||
| cis-cis Polyunsaturated Fat | 0 | % | |||
| trans Fat | 0 | % | |||
| Protein | <0.781 | % | |||
| 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 | 0.000 | % | |||
Regulatory compliance table showing compliance statements, regulation identifiers, scopes, and notes for VIVAPUR.
| Regulatory Compliance | ||||
|---|---|---|---|---|
| Compliance Item | Regulation Identifier | Status | Scope | Notes |
| VIVAPUR® is an EU approved food additive | Directive No. 231/2012/EC | complies | Europe | Please consider country-specific regulations for food. |
| Generally Recognized as Safe (GRAS) | US Food and Drug administration | considered to be Generally Recognized as Safe (GRAS) | USA | Cellulose is listed in the Select Committee on GRAS Substances database for use at levels that are now current or might reasonably be expected in the future. |
| VIVAPUR® is in compliance with JECFA (WHO). | JECFA (WHO) | in compliance | VIVAPUR® | |
| VIVAPUR® can be declared as gluten free | EU classification reg. EC No. 1169/2011 | can be declared as gluten free | EU | based on reg. EC No. 178/2002 |
| There is no labelling requirement for VIVAPUR® | European Union Regulation on genetically modified food and feed (EU 1829/2003 as amended) and European Union Regulation concerning traceability and labelling of food and feed products produced from genetically modified organisms (EU 1830/2003 as amended) | There is no labelling requirement | European Union | VIVAPUR® is made of cellulose from trees that are not genetically modified. |
| JRS Pharma recognizes the requirements on substances used in medicinal products according to the REACH legislation. | REACH legislation | recognizes | medicinal products | both active and inactive ingredients (excipients) are within the scope of this exemption |
| VIVAPUR® complies with the requirements of EMA/410/01. | EMA/410/01 | complies | VIVAPUR® | free of any rich forms of Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE) |
| ethylene oxide residues will be below the statutory limit of 0.1 mg/kg | regulation (EC) No 2022/1396 (amending Reg. 231/2012) | below the statutory limit of 0.1 mg/kg | ethylene oxide residues | If tested, ethylene oxide residues will be below the statutory limit of 0.1 mg/kg. |
| VIVAPUR® does not contain "microplastics". | European Chemicals Agency (ECHA), Annex XV restriction report (Proposal for a restriction) Substance name (S): intentionally added microplastics of 20 March 2019 | does not contain | microplastics | Based on this definition VIVAPUR® is not made from or contains "microplastics". |
| VIVAPUR® complies with the Commission Regulation (EC) No 1881/2006, as amended. | Commission Regulation (EC) No 1881/2006, as amended | complies | aflatoxins and mycotoxins | Individually products are not necessarily tested. |
| VIVAPUR® is in compliance with REGULATION (EU) No 511/2014 | REGULATION (EU) No 511/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 | in compliance | Nagoya Protocol | on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union |
| VIVAPUR® does not contain "nanomaterials". | EU REGULATION (EU) No 1169/2011 of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25th October 2011 | does not contain | nanomaterials | According to the RECOMMENDATION of the 18th October 2011 (EU) No 2011/696 "Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. |
| Pesticide levels in VIVAPUR® are below the statutory requirements | regulation (EC) No 396/2005 as amended | are below the statutory requirements | pesticides | regarding the guidance levels and limits of pesticides |
| The packaging corresponds with the regulations (EC) No 1935/2004, No 10/2011 as amended, and US 21CFR174. | regulations (EC) No 1935/2004, No 10/2011 as amended, and US 21CFR174 | corresponds with | packaging | The packaging corresponds with the regulations (EC) No 1935/2004, No 10/2011 as amended, and US 21CFR174. |
| VIVAPUR® meets the specifications set forth in the current version of the European pharmacopoeia and the residual components specification set in the Reg. (EU) 231/2012. | Reg. (EU) 231/2012 | meets the specifications set forth | Titanium dioxide | There are currently no regulations for a limit amount of TiO2. |
Regulatory compliance notes cover Ph. Eur., NF, JP, GMP manufacturing, residual solvent status, and ICH Q3D elemental impurity information.
Additional Regulatory Details
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>). Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>).
- detailed information is available on request.
Regulatory compliance notes include Ph. Eur., NF, JP, E460 (i), FCC, GMP for excipients, residual solvent and elemental impurity statements, plus a request-on-demand note for detailed information.
Regulatory Compliance Information
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>). Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.
- VIVAPUR is manufactured under GMP for excipients according to IPEC and USP <1078>.
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>).
- Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.
Regulatory compliance notes for Ph. Eur., NF, JP, GMP, residual solvents, and ICH Q3D requirements are provided for sourcing and quality review.
Regulatory & Compliance Information
- VIVAPUR is manufactured under GMP for excipients according to IPEC and USP <1078>. The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>).
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>).
- Residual Solvents
- detailed information is available on request
- Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.
Regulatory compliance notes, GMP statements, and elemental impurity disclosures relevant to sourcing and qualification.
Regulatory Compliance Information
- Ph. Eur., NF, JP
- E460 (i)
- VIVAPUR is manufactured under GMP for excipients according to IPEC and USP <1078>
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>, JP<2.46>)
- Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.
- 2021-08-01
- VIVAPUR® 112
Regulatory notes, compliance statements, and storage requirements for sourcing and documentation review.
Regulatory & Compliance Information
- Please consider country-specific regulations for food.
- Cellulose is listed in the Select Committee on GRAS Substances database for use at levels that are now current or might reasonably be expected in the future.
- based on reg. EC No. 178/2002
- VIVAPUR® is made of cellulose from trees that are not genetically modified.
- both active and inactive ingredients (excipients) are within the scope of this exemption
- free of any rich forms of Bovine Spongiform Encephalopathy (BSE) and Transmissible Spongiform Encephalopathy (TSE)
- If tested, ethylene oxide residues will be below the statutory limit of 0.1 mg/kg.
- The DMF number for VIVAPUR®, all types, is 11963.
- Based on this definition VIVAPUR® is not made from or contains "microplastics".
- Individually products are not necessarily tested.
- on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
- According to the RECOMMENDATION of the 18th October 2011 (EU) No 2011/696 "Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.
- regarding the guidance levels and limits of pesticides
- The packaging corresponds with the regulations (EC) No 1935/2004, No 10/2011 as amended, and US 21CFR174.
- There are currently no regulations for a limit amount of TiO2.
- protected from excessive heat and moisture
- original, unopened, well-closed containers. Inner bags should be sealed and drum or carton tightly secured when the entire contents of the package are not used.
- VIVAPUR® is recommended for declaration as "Microcrystalline Cellulose" or "E460 (i)". Please consider country-specific regulations for food.
- According to Ph. Eur., VIVAPUR® is recommended for declaration as "Microcrystalline Cellulose". Please consider country-specific regulations for pharma.
- Manufacturing sites Microcellulose Weissenborn, Germany, JRS Pharma LP, USA and Rettenmaier Natural Fiber Manufacturing, China are EXCIPACT™ certified.
- The manufacturing site Microcellulose Weissenborn, Germany is DIN EN ISO 9001:2015 and FSSC 22000 certified. The manufacturing sites JRS Pharma LP, USA and Rettenmaier Natural Fiber, China are DIN EN ISO 9001:2015 certified.
- The manufacturing site Microcellulose Weissenborn, Germany is DIN EN ISO 9001:2015 and FSSC 22000 certified.
- The suitability of the monograph of the European Pharmacopoeia was certified for VIVAPUR® for the manufacturing site Microcellulose Weissenborn, Germany. The registration No. is: R1-CEP 2007-321-Rev 01, valid as of 03-04-2014.
- The Quality System of the manufacturing sites is based on the GMP regulations issued by WHO and/or the GMP regulations for Excipients issued by IPEC Europe and IPEC USA, and published in the USP.
- VIVAPUR® is certified as halal - for Microcellulose Weissenborn, Germany by HALAL Control.
- VIVAPUR® is certified as halal - for JRS Pharma LP, USA by IFANCA.
- VIVAPUR® is certified as halal - for Rettenmaier Natural Fiber Manufacturing, China by HALAL Control.
- VIVAPUR® is certified as kosher - for Microcellulose Weissenborn, Germany by OK Kosher,
- VIVAPUR® is certified as kosher - for JRS Pharma LP, USA by OK Kosher,
- VIVAPUR® is certified as kosher - for Rettenmaier Natural Fiber Manufacturing, China by KOF-K Kosher Supervision.
- VIVAPUR® is an EU approved food additive which complies with the specifications according to Directive No. 231/2012/EC described under E460 (i) monograph "Microcrystalline Cellulose".
- VIVAPUR® products are considered to be Generally Recognized as Safe (GRAS) by the US Food and Drug administration.
- VIVAPUR® is in compliance with JECFA (WHO).
- Microcrystalline Cellulose monograph is included in the current editions of Ph. Eur., NF and JP. VIVAPUR® complies with the Ph. Eur., NF, JP and ChP monographs "Microcrystalline Cellulose" current editions and meets all parameters and limits.
- The Change Control Program to inform customers about significant changes is based on the "IPEC Significant Change Guideline".
- JRS Pharma recognizes the requirements on substances used in medicinal products according to the REACH legislation. Based on the above article, it is our understanding that both active and inactive ingredients (excipients) are within the scope of this exemption.
- The raw materials, manufacturing process and product do not contain any of the Class 1, Class 2 or Class 3 solvents listed in Residual Solvents USP<467>, Ph. Eur. < 5.4> and ICH Q3C.
- VIVAPUR® is manufactured by the following subsidiaries of JRS: Microcellulose Weissenborn GmbH & Co KG in Germany JRS PHARMA LP in USA Rettenmaier Natural Fiber Manufacturing Co., Ltd. in China.
- VIVAPUR® can be declared as gluten free according to EU classification reg. EC No. 1169/2011 based on reg. EC No. 178/2002.
- There is no labelling requirement for VIVAPUR® according to the European Union Regulation on genetically modified food and feed (EU 1829/2003 as amended) and European Union Regulation concerning traceability and labelling of food and feed products produced from genetically modified organisms (EU 1830/2003 as amended).
- VIVAPUR® is not contaminated with banned substances and does not come into contact with banned substances.
- VIVAPUR® does not contain of any substances of very high concern above 0.1 %, substances listed on annex XIV, submitted to authorization, or listed on the candidate list published by ECHA, which we regularly follow the updates.
- VIVAPUR® is suitable for vegans and ovo-lacto-vegetarians.
- VIVAPUR® has not been tested on animals and no animal testing is planned.
- No Titanium dioxide is intentionally used during the manufacturing process, nor is intentionally added in the final product VIVAPUR®.
- VIVAPUR® does not contain any toxic, narcotic or psychotropic sources and does not contain any additive/ excipient obtained from toxic, narcotic or psychotropic sources.
- Black specks are inherent to cellulose. VIVAPUR® is produced from purified wood pulp. High demands are made on the purity of the pulp, but small amount of impurities left in the pulp are uncooked wood pieces, bark and resin.
- VIVAPUR® is not a biotechnology product, therefore there is no risk for viral contamination.
Regulatory compliance notes for GMP manufacturing, residual solvents, and elemental impurities are available for this product.
Regulatory & Compliance Information
- VIVAPUR is manufactured under GMP for excipients according to IPEC and USP <1078>
- The raw materials, manufacturing process, and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur .< 5.4>, USP<467>, JP<2.46>)
- Elements listed in ICH Q3D Guideline for elemental impurities are not used in manufacturing and not analyzed per batch; detailed information is available on request.