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Acconon® C-50 EP/NF

Stearoyl macrogolglycerides are mixtures of monoesters, diesters and triesters of glycerol and monoesters and diesters of macrogols (polyethylene glycols (PEG) with a mean relative molecular mass between 300 and 4000). They are obtained by partial alcoholysis of saturated oils containing mainly triglycerides of stearic acid using macrogol (PEG) or by esterification of glycerol and macrogol (PEG) with saturated fatty acids or by mixture of glycerol esters and condensates of ethylene oxide with the fatty acids of these hydrogenated oils. The product may contain free polyethylene glycols, and appears as a pale-yellow, waxy solid. It is manufactured in USA.

Brand: Acconon (30 products)

Chemical Name: Stearoyl Macrogolglycerides

CAS Number: 9011-21-6

Functions: Bioavailability Enhancer, Carrier, Emulsifier, Encapsulant, Solubilizer, Surfactant

Dosage Form: Capsules, Creams, Lotions, Ointments, Tablets

Labeling Claims: Aflatoxin-free, BSE-free, CMR Substances-free, Mycotoxins-free, Non-GMO, Polychlorinated Biphenyls (PCB)-free, TSE-free, Vegan

Certifications & Compliance: BRC Certified, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Generally Recognized As Safe (GRAS), Hazard Analysis Critical Control Point (HACCP), ISO 9001, National Formulary (NF), United States Pharmacopeia (USP), Vegan

Synonyms: Glyceryl polyoxyethylene stearate, Macrogol 20 glyceryl monostearate, PEG glyceryl stearate, Poly(oxyethylene) glyceryl stearate, Polyethylene glycol glycerol stearate, Polyethylene glycol glyceryl stearate, Polyoxyethylene glycerol stearate

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name
Stearoyl Macrogolglycerides
Pharma & Nutraceuticals Functions
Bioavailability Enhancer,
Carrier,
Emulsifier,
Encapsulant,
Solubilizer,
Surfactant
CAS No.
9011-21-6
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Carriers & Bulking Agents,
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
Modified & Controlled Release,
Other Excipients,
Solvents & Solubilizers

Features & Benefits

Labeling Claims
Aflatoxin-free,
BSE-free,
CMR Substances-free,
Mycotoxins-free,
Non-GMO,
Polychlorinated Biphenyls (PCB)-free,
TSE-free,
Vegan

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Nasal,
Oral,
Topical,
Transdermal
Dosage Form
Capsules,
Creams,
Lotions,
Ointments,
Tablets
Manufacturing Technology
Encapsulation
Applications
  • High melt point solubilizer, bio-availability enhancer
  • Solid dispersions or physical mixtures
  • Surfactant
  • Unique release properties based on application
  • Emulsification
  • Encapsulation

Properties

Physical Form
Solid
Typical Properties
ValueUnitsTest Method / Conditions
Residual Dioxanemax. 10ppmEP/NF
Residual Ethylene Oxidemax. 1ppmEP/NF
Fatty Acid Composition
ValueUnitsTest Method / Conditions
C12 (Lauric Acid)max. 5.0%EP/NF
C14 (Myristic Acid)max. 5.0%EP/NF
C16 (Palmitic Acid)40.0 - 50.0%NF
C18 (Stearic Acid)48.0 - 58.0%NF
Total Stearic Palmitic combinedmin. 90.0%EP
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 2.0mg KOH/gEP/NF
Alkaline Impurities (0.01N HCL)max. 1.0mL¹EP/²NF
Free Glycerolmax. 3.0%EP/NF
Hydroxyl Value25 - 56mg KOH/gEP/NF
Hydroxyl Value85 - 115mg KOH/g (% la³)EP/NF
Iodine Valuemax. 2.0cg I2/gNF
Peroxide Valuemax. 6.0meq O2/kgEP/NF
Saponification Value67 - 112mg KOH/gEP/NF
Saponification Value90 - 110mg KOH/g (% la³)EP/NF
Total Ashmax. 0.2%EP/NF
Water Contentmax. 1.0%EP/NF (Karl Fischer)
Note

¹EP: European Pharmacopeia

²USP/NF: United States Pharmacopeia/National Formulary

³Labeled Amount

 

Regulatory & Compliance

Certifications & Compliance
BRC Certified,
European Pharmacopeia (Ph. Eur.),
FDA Compliant,
GMP,
Generally Recognized As Safe (GRAS),
Hazard Analysis Critical Control Point (HACCP),
ISO 9001,
National Formulary (NF),
United States Pharmacopeia (USP),
Vegan
Grade
Pharma Grade
Regulatory

Meets the requirements of current European Pharmacopeia (EP) and United States Pharmacopeia/National Formulary (USP/NF) Monographs for Stearoyl Macrogolglycerides / Stearoyl Polyoxylglycerides.

Packaging & Availability

Packaging Type
Drums
Standard Packaging
  • 425 lb (192.8 kg) drum
  • 40 lb (18.1 kg) HDPE

Storage & Handling

Shelf Life
24 months
Recommended Storage and Handling
  • Retest/requalify 24 months after manufacture
  • Store in a cool dry location. Preserve in tight containers and protect from light and moisture