Niacet Sodium Acetate Pharma

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.

Chemical Name: Sodium Acetate

CAS Number: 127-09-3

Functions: Buffers & pH Stabilizer

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

Labeling Claims: Halal

Synonyms: NaOAc

Technical Data Sheet

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Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
127-09-3
EC No.
204-823-8

Features & Benefits

Labeling Claims
Product 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.

Applications & Uses

Applicable Processes
Applications
  • Sodium Acetate pharmaceutical grade is used in the preparation of haemodialysis and peritoneal dialysis solutions, in the production of insulin and in infusion liquids.
  • Sodium acetate is also used in leather tanning and textile dyeing, in the photographic industry, as a polymerization catalyst, in detergents and for thermal energy storage.

Properties

Physical Form
Appearance
White powder or agglomerate
Typical Properties
ValueUnitsTest Method / Conditions
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 temperature 607 °C
Thermal Properties
ValueUnitsTest Method / Conditions
Solubility(ies)(25°C)505 kg/m³

Regulatory & Compliance

Certifications & Compliance
Quality Standards

Packaging & Availability

Packaging Information

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

Storage & Handling

Shelf Life
3 years
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