FLOCEL 102 Microcrystalline Cellulose - JRS PHARMA
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FLOCEL 102 is a Microcrystalline Cellulose grade for pharmaceutical and food applications, with references to Ph. Eur., NF, ChP, E460(i), and FCC.
Microcrystalline cellulose excipient for pharmaceutical and food-related applications.- Referenced against Ph. Eur., NF, ChP, E 460(i), and FCC.
- Manufactured from 100% wood-based cellulose pulp.
- Suitable for vegan and ovo-lacto-vegetarian applications.
- Common EU/FALCPA allergens are absent, including gluten, milk/lactose, soy, nuts, sesame, and sulphites above threshold.
- Recommended re-evaluation period is 5 years from the date of manufacture.
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 |
| 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 |
Shows EU and US-format nutritional values per 100 g.
| Nutritional Values | |
|---|---|
| Nutritional Values - EU | Values per 100g |
| Calorific value: | 200 kcal or 801 kJ/100 g |
| Protein | 0.0 g |
| Usable carbohydrate | 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 | > 94 g |
| Sodium | < 0,03 g |
| Nutritional Values - US | Avg. Units per 100 g |
| Carbohydrates | 95.8% |
| Carbohydrates, Available | 0.0% |
| Calories | 0 Calories/100 g |
| Calories from Fat | 1 Calories/100 g |
| Calories from Saturated Fat | 0 Calories/100 g |
| Calories (Insoluble Fiber Subtracted) | 1 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 | <0.012% |
| Moisture | 4.157% |
| Total Fat | 0.06% |
| Saturated Fat | 0.00% |
| Monounsaturated Fat | 0.06% |
| cis-cis Polyunsaturated Fat | 0.00% |
| trans Fat | 0.00% |
| Protein | <0.781% |
| Insoluble Fiber | 98.9% |
| Soluble Fiber | <0.2% |
| Total Fiber | 98.9% |
| Fructose | Less than 0.1% |
| Glucose | Less than 0.1% |
| Sucrose | Less than 0.1% |
| Maltose | Less than 0.1% |
| Total Sugars | 0.000% |
Shows maximum heavy metal levels from the regulatory information.
| 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 |
FLOCEL 102 and Microcrystalline Cellulose are presented with detailed ingredient profile information, including compendial identification, purity, microbial limits, particle-size specifications, and the source document FLOCEL 102.pdf.
Composition and Origin
FLOCEL is pure microcrystalline cellulose manufactured from cellulose pulp obtained from 100% wood. Only acid and base are used as process ingredients.
Technical specifications table showing characteristic names, acceptance criteria, and reference methods for FLOCEL 102.
| Technical Specifications | ||
|---|---|---|
| Parameter | Acceptance Criteria | Reference Method |
| Identification A | IR Scan conforms | Ph. Eur., NF |
| Identification B, (1) | Violet-blue color | Ph. Eur., NF, ChP |
| Identification C, (2) | Max. 350 | Ph. Eur., NF, ChP |
| Arsenic | Max. 0.0002 % | JRS Method1/ChP1 |
| Chloride | Max. 0.03 % | JRS Method1/ChP1 |
| Conductivity | Max. 75 uS/ cm | Ph. Eur., NF, ChP |
| Ether-soluble substances | Max. 0.05 % | Ph. Eur., NF, ChP |
| Heavy Metals | Max. 10 ppm | JRS Method1/ChP1 |
| Loss on drying | Max. 6.0 % | Ph. Eur., USP, ChP |
| pH | 5.0 - 7.0 | Ph. Eur., USP, ChP |
| Solubility | Dissolves completely | Ph. Eur. |
| Starch | Negative | ChP |
| Sulphated ash / residue on ignition | Max. 0.05 % | Ph. Eur., USP, ChP |
| Water-soluble substances | Max. 0.2 % | Ph. Eur., NF, ChP |
| TAMC (Total Aerobic Microbial Count) | Max. 102 cfu/ g | Ph. Eur., USP |
| TYMC (Total Yeast and Mold Count) | Max. 20 cfu/ g | Ph. Eur., USP |
| Escherichia coli | Absent in 1 g | Ph. Eur., USP |
| Pseudomonas aeruginosa | Absent in 1 g | Ph. Eur., USP |
| Salmonella species | Absent in 10 g | Ph. Eur., USP |
| Staphylococcus aureus | Absent in 1 g | Ph. Eur., USP |
| Bulk density | 0.27 - 0.34 g/ mL | NF |
| Particle Size (retained on sieve) | Acceptance Criteria | Method |
| > 250 um (60 mesh) | Max. 8 % | JRS Method |
| > 75 um (200 mesh) | Min. 45 % | JRS Method |
Regulatory compliance table showing regulation identifiers, compliance statuses, scope, and notes for FLOCEL.
| Regulatory Compliance | |
|---|---|
| Regulatory Area | Status / Reference |
| EU food compliance | FLOCEL is an EU-approved food additive and complies with E 460(i) specifications for Microcrystalline Cellulose. |
| US food compliance | FLOCEL is described as GRAS and complies with the Food Chemical Codex Monograph for Cellulose Gel. |
| Residual solvents | Raw materials, manufacturing process, and product do not contain Class 1, 2, or 3 solvents listed under USP <467>, Ph. Eur. <5.4>, and ICH Q3C. |
| Elemental impurities | Elemental impurities are evaluated using ICP-MS per USP-NF <233>; detailed information is available on request. |
Covers product identity, regulatory references, origin, and re-evaluation period.
What is FLOCEL 102?
FLOCEL 102 is a Microcrystalline Cellulose grade.
What is the composition?
It is pure microcrystalline cellulose manufactured from 100% wood-based cellulose pulp.
What storage condition is recommended?
Store FLOCEL in original, unopened, well-closed containers protected from excessive heat and moisture. If opened, seal inner bags and tightly secure outer bags or cartons when the full contents are not used.
What is the re-evaluation period?
FLOCEL has a recommended re-evaluation period of 5 years from the date of manufacture.
Shows storage conditions and re-evaluation handling for FLOCEL.
Storage and Handling
- Store in original, unopened, well-closed containers.
- Protect from excessive heat and moisture.
- Inner bags should be sealed and outer bags or cartons tightly secured when the entire contents are not used.
- Recommended re-evaluation period is 5 years from the date of manufacture.
- An additional year can be added after re-evaluation if loss on drying remains within specification.