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Pharmaceutical Chemistry
Meglumine
Formula:
C7H17NO5
GOST/CAS:
CAS 6284-40-8
Meglumine (N-Methyl-D-glucamine) is a high-purity amino sugar derived from glucose, widely utilized as an excipient in the pharmaceutical industry. It serves as an effective counter-ion to enhance the solubility and stability of weakly acidic drug substances and is a key component in the synthesis of radiopaque contrast media. Due to its excellent biocompatibility and safety profile, Meglumine is indispensable in the formulation of injectable solutions, ophthalmic preparations, and oral dosage forms.
Applications
Solubility Enhancement of APIs: Used to form highly soluble salts with weakly acidic Active Pharmaceutical Ingredients (APIs), significantly improving their hydrophilicity, bioavailability, and dissolution rate.
Contrast Media Production: Acts as a crucial component in the manufacturing of iodinated X-ray contrast agents and magnetic resonance imaging (MRI) contrast media (e.g., meglumine amidotrizoate, gadopentetate meglumine).
Solution Stabilization: Functions as a buffering agent and organic pH stabilizer in parenteral (injectable and infusion) formulations, preventing the degradation of pH-sensitive molecules.
Ophthalmics and Oral Dosage Forms: Incorporated into eye drops and solid oral dosages to adjust tonicity, control pH, and enhance the absorption of active ingredients.
Key Advantages
High Pharmaceutical Purity: Complies with the stringent requirements of major international pharmacopoeias (USP, EP, JP, ChP), ensuring minimal levels of related impurities and heavy metals.
Premium Solubilizer: Efficiently converts poorly soluble acids into stable, highly water-soluble salts without altering their original therapeutic efficacy.
Biocompatibility and Safety: Non-toxic, non-irritating, completely excreted by the body, and fully approved for use in sterile and parenteral drug products.
Robust pH Buffering: Provides reliable pH stabilization within a physiologically optimal range, effectively extending the shelf life of finished liquid formulations.
Storage & Transportation
- Store in dry, clean, and cool warehouses in the tightly closed original packaging, away from heat sources and incompatible materials (strong oxidizers).
- Recommended storage temperature: +15 °C to +25 °C. Protect from moisture (the product is hygroscopic) and direct sunlight.
- Transportation is permitted by all modes of covered transport in strict compliance with standard cargo regulations. This material is classified as non-hazardous for transport.
- Shelf life — 3 years from the date of manufacture.
Technical Specifications
Appearance
White or almost white crystalline powder, odorless
Molecular Weight
195.21 g/mol
Assay (On Dry Basis)
≥ 99.0%
Melting Point
128 °C – 132 °C
pH (10% Aqueous Solution)
10.0 – 11.5
Loss on Drying
≤ 1.0%
Supply info
- Double polyethylene bags placed inside durable 25 kg fiber drums (standard pharmaceutical-grade packaging).
- Custom packaging, such as 10 kg bags or smaller tailored options for pilot and R&D batches, is available upon request.