Protanal® PH - 1033

1 of 28 products in this brand
Protanal® PH - 1033 is a versatile powder free from sewage sludge. Ideal for pharmaceuticals and nutraceuticals, it serves as a controlled release agent, gelling agent, thickener, and stabilizer. Plus, it offers antacid properties, ensuring top-notch performance in various applications.

Chemical Name: Sodium Alginate

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Antibiotics-free, Artificial Flavor-Free, BSE-free, Bactericide-free, Barium-free, Bisphenol A-free, CMR Substances-free, Cadmium-free, Caffeine Free, Cobalt-free, Colorants-free, Copper-free, Dioxin-free, Endocrine Disruptor-free, Fungicide-free, GMO-free, Generally Recognized As Safe (GRAS), Gluten-free, Glycerin-free, Gold-Free, Herbicide-free, Hormones-free, Impurities-free, Kosher, Mercury-Free, Monosodium Glutamate (MSG)-free, NPE-free, Natural Latex Rubber-Free, No Artificial Sweeteners, Non-GMO, PAH-free, PFAS-Free, PFOA-free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Perfluorocarbon (PFC)-free, Pesticide-free, Phthalates-free, Plasticizer-free, Potassium-free, Preservative-free, Quaternary Ammonium Salt-Free, Radioactive-free, Residual Solvent -Free, Solvent-free, Steroids Free, Sugar-free, TSE-free, Tin-free, Tributyltin (TBT) - 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 21 CFR 117, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FFDCA, Generally Recognized As Safe (GRAS), IFRA Compliant, Japan Pharmacopeia (JP), National Formulary (NF), Regulation (EU) No. 231/2012, United States Pharmacopeia (USP), cGMP

Chemical Inventories: AICS (Australia), DSL (Canada), ENCS (Japan), IECSC (China), NDSL (Canada), PICCS (Phillipines)

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Enhanced TDS

Identification & Functionality

Chemical Family
Alginates
Chemical Name
Sodium Alginate
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,
Allergen-free,
Aluminum-free,
Antibiotics-free,
Artificial Flavor-Free,
BSE-free,
Bactericide-free,
Barium-free,
Bisphenol A-free,
CMR Substances-free,
Cadmium-free,
Caffeine Free,
Cobalt-free,
Colorants-free,
Copper-free,
Dioxin-free,
Endocrine Disruptor-free,
Fungicide-free,
GMO-free,
Generally Recognized As Safe (GRAS),
Gluten-free,
Glycerin-free,
Gold-Free,
Herbicide-free,
Hormones-free,
Impurities-free,
Kosher,
Mercury-Free,
Monosodium Glutamate (MSG)-free,
NPE-free,
Natural Latex Rubber-Free,
No Artificial Sweeteners,
Non-GMO,
PAH-free,
PFAS-Free,
PFOA-free,
PFOS-free,
PHO (Partially Hydrogenated Oil)-Free,
PVC-free,
Palm Oil-free,
Paraben-free,
Perfluorocarbon (PFC)-free,
Pesticide-free,
Phthalates-free,
Plasticizer-free,
Potassium-free,
Preservative-free,
Quaternary Ammonium Salt-Free,
Radioactive-free,
Residual Solvent -Free,
Solvent-free,
Steroids Free,
Sugar-free,
TSE-free,
Tin-free,
Tributyltin (TBT) - Free,
Vegetarian

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Pharmaceutical Manufacturing
Excipients & Coatings,
Pharmaceutical Processing
Segments
Home and Personal Care,
Pharmaceutical
Applications
Pharmaceutical — Controlled release
Home and Personal Care — Skin care

Properties

Physical Form
Powder
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
pH (at 0.5%)6.4 - 8.5-6
Viscosity (at 0.5% solution)300 - 800mPa.s82Q
Loss on Drying7 - 14%1
Ash Content (on dry matter)18.0 - 27.0%8C
Particle Size (through 250 micron)min. 98%106
Particle Size (through 180 micron)min. 91%106
Sodium Alginate Content (Assay)90.8 - 106%42
Calcium Content2 - 4%7
Powder Color64 - 80-105
Identification*Passes Tests-44
Microbiological Values
ValueUnitsTest Method / Conditions
Total Viable Mesophilic Aerobic Countmax. 200cfu/g201C, Usp
Yeast and Mold Countmax. 200cfu/g203A
SalmonellaAbsent/25g205
Staphlococcus aureusAbsent/0.5g206
E. coliAbsent/25g204
Pseudomonas aeruginosaAbsent/0.5g207
ColiformNegativeMPN204
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 21 CFR 117,
FDA Compliant,
FDA Food Safety Modernization Act (FSMA),
FFDCA,
Generally Recognized As Safe (GRAS),
IFRA Compliant,
Japan Pharmacopeia (JP),
National Formulary (NF),
Regulation (EU) No. 231/2012,
United States Pharmacopeia (USP),
cGMP
Chemical Inventories
AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
NDSL (Canada),
PICCS (Phillipines)

Packaging & Availability

Packaging Type
Drums

Storage & Handling

Shelf Life
15 months
Storage and Shelf Life Conditions

Recommended store at cool and dry conditions. Keep containers sealed as material is hygroscopic. Re-evaluation date is 15 months from date of manufacture, if storage conditions stated above are observed.