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Pharmaceutical Chemistry
Inorganic Salts for Injections
Formula:
C2H8N2O4
GOST/CAS:
CAS - 1113-38-8
Inorganic salts for injections are high-purity chemical substances intended for the manufacture of sterile dosage forms, infusion and injection solutions, as well as eye drops. The products are manufactured under strict GMP compliance, guaranteeing ultra-low levels of bacterial endotoxins, heavy metals, and particulate matter. Characterized by perfect solubility and high stability, these salts ensure precise maintenance of osmotic pressure, electrolyte balance, and pH levels in finished medicinal products.
Applications
Production of Infusion Solutions: Used as base components for formulation of saline, rehydration, and plasma-substituting solutions (Ringer's solutions, physiological saline, etc.).
Injectable Preparations: Applied for dissolving and diluting lyophilizates, as well as liquid dosage forms for intravenous, intramuscular, and subcutaneous administration.
Eye Drops and Ophthalmology: Used as tonicity and osmolarity regulators in ophthalmic products to prevent tissue irritation.
Culture Media and Biotechnology: Utilized as essential mineral components in cell culture cultivation and the bioprocess manufacturing of active biological substances.
Key Advantages
Ultra-High Purity (GMP Grade): Assay levels are close to an absolute $99.9\% - 100\%$. The minimal presence of impurities eliminates the risk of adverse reactions during administration.
Endotoxin and Pyrogen Control: All substances undergo rigorous microbiological testing, guaranteeing safety for use in sterile finished dosage forms.
Excellent Solubility: The crystal structure is optimized for rapid and complete dissolution in water for injections without any precipitate formation.
Stable Physico-Chemical Profile: Strictly regulated particle size distribution and a complete absence of residual organic solvents.
Storage & Transportation
- Store in original, tightly sealed manufacturer's packaging in dry, cool, and well-ventilated warehouse premises, protected from light.
- Maintain the recommended temperature regime (typically +5°C to +25°C); avoid sharp temperature fluctuations to prevent product caking.
- Transportation is permitted by all types of covered transport in accordance with standard cargo regulations. Shelf life — 3 to 5 years (depending on the specific salt type).
Frequently bought together
Technical Specifications
Appearance
White crystalline powder or colorless crystals
Assay
99.5% – 100.5% (on dried basis)
Bacterial Endotoxins
Less than 0.005{IU/mg} / Complies with Ph.Eur./USP
Heavy Metals
≤ 5ppm
Supply info
- Multi-wall paper bags with a double internal polyethylene liner, 25 kg net weight.
- Airtight plastic drums / kraft fiber drums of 25 kg and 50 kg (for advanced moisture protection).
- Custom packaging in cleanrooms is available upon agreement with the customer.