Protanal® CR - 8133

1 of 28 products in this brand
Protanal® CR - 8133 featuring sodium alginate, serves various functions in pharmaceuticals and nutraceuticals. It acts as an antacid, controlled release agent, emulsifying agent, gelling agent, thickener, and viscosity modifier, available in powder form.

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, Odor-free, 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, ISO 14001, 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,
Emulsifier,
Gelling Agent,
Stabilizer,
Suspending Agent,
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,
Odor-free,
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 Drying7 - 13%SOM 1
Viscosity (at 2% solution)100 - 300mPa.sSOM 82
pH (at 2% solution)6.4 - 8.0-SOM 6
Calcium Contentmax. 0.5%SOM 7B
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 150 micron)min. 95%SOM 106
Particle Size (through 106 micron)min. 85%SOM 106
Heavy Metals
ValueUnitsTest Method / Conditions
Lead Contentmax. 5ppm22
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,
ISO 14001,
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 328 kcal
Energy from fat 0 kcal 0 kcal
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.