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Niacet Sodium Acetate Pharma

CAS Number
127-09-3
EC Number
204-823-8
Chemical Name
Sodium Acetate

Niacet’s acetates, mainly sodium acetate are used in the production of insulin. Additionally, as a constituent in insulin products, sodium acetate acts as an oxidative fuel preventing the body from producing antibodies during insulin injection. Sodium Acetate is available as an agglomerate and a powder (anhydrous) as well as a crystal (trihydrate). Sodium Acetate trihydrate is very soluble in water. Sodium Acetate anhydrous agglomerate offers the properties of non-dustiness, improved wettability, higher reactivity, higher bulk density, and improved free-flow ability.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
Buffers & pH Stabilizer

Product families

Applications

Industrial — Chemical & Industrial Manufacturing
  • Chemical Manufacturing
Healthcare & Pharma — Drug Delivery & Care Solutions
  • Nasal
  • Ophthalmic
  • Oral
  • Topical
Healthcare & Pharma — Pharmaceutical Manufacturing
  • API Manufacturing

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Formulation & Processing Aids
  • Microbial Control & Preservation
Plastics — Polymer Additives
  • Performance Additives
Base Chemicals & Intermediates — Technical Salts & Inorganics
  • Organic Salts

Other characteristics

Synonyms
NaOAc
Functions
Buffers & pH Stabilizer
Dosage Form

Capsules, Creams, Foams, Gels, Lotions, Ointments, Tablets; Capsules; Creams; Foams; Gels; Lotions; Ointments; Tablets

Labeling Claims
Halal
Markets
  • Healthcare & Pharma
  • Industrial
Stability

Pharmaceutical grade Sodium Acetate is stable for 3 years from date of production. All other grades have 2 years stability. Physical stability and appearance may change before the end of shelf-life if not stored single-stacked in closed original packaging, dry and at room temperature

Appearance
White powder or agglomerate
Shelf LIfe
3 years
Technology
  • Base Chemicals & Intermediates
  • Pharmaceuticals & Nutraceuticals
  • Plastics
Quality Standards
EDQM
Background

Niacet's acetates, mainly sodium acetate but also ammonium acetate, potassium acetate, and zinc acetate are used in the production of insulin. Additionally, as a constituent in insulin products, sodium acetate acts as an oxidative fuel preventing the body from producing anti bodies during insulin injection.. Sodium acetate trihydrate at Tiel, NL site is certified by the Health Care Inspectorate – Pharmaceutical Affairs Medical Technology of the Dutch Ministry with Good Manufacturing Practices (GMP) certification. This certification affirms Niacet's commitment to supplying the highest quality active ingredients and excipients for the pharmaceutical industry.

Applicable Processes
Insulin Manufacturing
Packaging Information

Depending on product form in 20kg or 25kg polyethylene lined paper bags, 450kg, 500kg, 900kg, 990kg and 1000kg big bags.

Certifications and Compliance
  • GMP
  • REACH (Europe)

Technical data

Table 1 of 2

9 rows
CharacteristicValueUnit
Heavy metals Contentmax. 2ppm
Assay Content99-101—
Sulphate Contentmax. 50ppm
Water Contentmax. 0.5%
Chloride contentmax. 200ppm
Insoluble In Watermax. 200ppm
pH (1% solution)8.0 - 9.0—
Melting Point324°C
Auto-ignition temperature607°C

Table 2 of 2

1 row
CharacteristicValueUnit
Solubility(ies)(25°C)505kg/m³

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