Protanal® CR - 8223

1 of 28 products in this brand
Protanal® CR - 8223 formulated with sodium alginate, features labeling claims of being gold-free. With its powder form, it functions as an antacid, controlled release agent, gelling agent, stabilizer, and thickener in pharmaceutical and nutraceutical applications.

Chemical Name: Sodium Alginate

Labeling Claims: APE-free, Aluminum-free, Antibiotics-free, BSE-free, Barium-free, Bisphenol A-free, Cadmium-free, Caffeine Free, Cobalt-free, Colorants-free, Copper-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, GMO-free, Generally Recognized As Safe (GRAS), Glycerin-free, Gold-Free, Hormones-free, Kosher, Mercury-Free, Monosodium Glutamate (MSG)-free, Natural Latex Rubber-Free, Nitrosamines-free, Non-GMO, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plasticizer-free, Preservative-free, Residual Solvent -Free, Solvent-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegetarian

Certifications & Compliance: British Pharmacopeia (BP), Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA Compliant, FDA Food Safety Modernization Act (FSMA), IFRA Compliant, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Technical Data SheetSafety Data SheetBrochure
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Enhanced TDS

Identification & Functionality

Chemical Family
Alginates
Chemical Name
Sodium Alginate
Ingredient Origin
Non-Animal Origin
Pharma & Nutraceuticals Functions
Antacid,
Controlled Release Agent,
Gelling Agent,
Stabilizer,
Thickener,
Viscosity Modifier
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
Modified & Controlled Release
Pharmaceuticals & Nutraceuticals — Pharmaceutical Actives & Precursors
Active Pharmaceutical Ingredients (APIs)

Features & Benefits

Labeling Claims
APE-free,
Aluminum-free,
Antibiotics-free,
BSE-free,
Barium-free,
Bisphenol A-free,
Cadmium-free,
Caffeine Free,
Cobalt-free,
Colorants-free,
Copper-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
GMO-free,
Generally Recognized As Safe (GRAS),
Glycerin-free,
Gold-Free,
Hormones-free,
Kosher,
Mercury-Free,
Monosodium Glutamate (MSG)-free,
Natural Latex Rubber-Free,
Nitrosamines-free,
Non-GMO,
PAH-free,
PFAS-Free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Perfluorooctanoic Acid-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Preservative-free,
Residual Solvent -Free,
Solvent-free,
Sugar-free,
TSE-free,
Tributyl Tin Compounds-Free,
Triphenyl Tin Compounds-Free,
Vegetarian

Applications & Uses

Segments
Dietary Supplement,
Pharmaceutical
Applications
Dietary Supplement — Controlled release
Pharmaceutical — Controlled release

Properties

Physical Form
Powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Drying6 - 12%SOM 1
Viscosity (at 1.25% solution)600 - 900mPa.sSOM 82
pH (at 1.25%)6.4 - 8.0-SOM 6
Calcium Contentmax. 0.5%SOM 7I
Ash Content (on DM, 800c)18.0 - 27.0%SOM 8C
Sulphated Ash (650c)30.0 - 36.0%SOM 8A
Powder Colormin. 64-SOM 105
Chloride Contentmax. 1.0%SOM 31
Sodium Alginate Content (Assay)90.8 - 106.0%SOM 2F
ID Test*Passes Tests-SOM 44
Microbiological Values
ValueUnitsTest Method / Conditions
Total Viable Mesophilic Aerobic Count (USP)max. 200cfu/g201 (EP)
Total Viable Mesophilic Aerobic Count (Ph Eur)max. 2000cfu/g201 (EP)
Yeast Countmax. 100cfu/g203 (EP)
Mold Countmax. 100cfu/g203 (EP)
SalmonellaAbsent/25g205 (EP)
Staphylococcus aureusAbsent/1g206 (EP)
E. coliAbsent/25g204A (EP)
Pseudomonas aeruginosaAbsent/1g207 (EP)
ColiformNegativeMPN/25g204 (EP)
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (through 250 micron)min. 95%SOM 106
Particle Size (through 180 micron)min. 90%SOM 106
Heavy Metals
ValueUnitsTest Method / Conditions
Lead Contentmax. 5ppm22
Iron Contentmax. 375ppm22
Arsenic Contentmax. 1.5ppm22
Note

*NF and Ph. Eur. ID tests; “A” and “B” on a quarterly basis. ID tests “C” (NF and Ph. Eur.) and “D” (Ph. Eur.) will be completed by exception only.

Regulatory & Compliance

Certifications & Compliance
British Pharmacopeia (BP),
Doping-Free,
EU Cosmetic Regulation 1223/2009 Compliant,
EXCiPACT,
European Pharmacopeia (Ph. Eur.),
European Regulation 396/2005/EC,
FCC Compliant,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
IFRA Compliant,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
Regulation (EU) No. 1272/2008,
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP)

Technical Details & Test Data

Typical Nutrient Information/100g
  EU/Australia/NZ US
Energy 164 kcal 687 kJ

328 kcal 1374 kJ
Energy from fat 0 kcal 0 kJ 0 kcal 0 kJ
Total fat 0 g 0 g
Saturated fat 0 g 0 g
Trans-fat 0 g 0 g
Cholestrol 0 g 0 g
Sodium 9100 mg 9100 mg
Potassium 0 mg 0 mg
Total carbohydrate 0 g 82 g
Sugars 0 g 0 g
Starch 0 g 0 g
Fibers 82 g 82 g
Protein < 1 g < 1 g
Vitamin A 0 g 0 g
Vitamin C 0 g 0 g
Calcium 300 mg 300 mg
Magnesium 0 g 0 g
Ash 23 g 23 g
Moisture 9 g 9 g

Storage & Handling

Shelf Life
12 months
Shelf Life Information

Recommended store at cool and dry conditions. Keep containers sealed as material is hygroscopic. Re-evaluation date is 12 months from date of manufacture, if storage conditions stated above are observed. IFF recommends that after the above re-evaluation date, the customer considers that loss on drying, pH and viscosity are tested to establish whether material is still within listed specification.