Meglumine

Meglumine is an organic base used as a pH-adjusting agent and solubilizing agent in Solid orals and parenteral formulations. Many APIs gets rapidly ionized in the presence of acidic pH and which leads to decreased absorption. This problem can be overcome by using Meglumine i.e., as a basic agent which helps dissolve such APIs. Meglumine is manufactured with extreme precaution in our laboratory certified by EXCiPACT, ISO and GMP. We also provide robust regulatory documentation including Nitrosamine and elemental impurities risk assessment documents for pharma applications.

Applications

Meglumine is extensively used in the pharmaceutical industry for a variety of reasons:

  • Meglumine is an organic base used as a pH-adjusting agent
  • It is also used as a solubilizing agent in Solid orals and Parenteral formulations.

General Information

Pharmacopeia Status : USP, Ph.Eur, BP, Ch.P

CAS No. : 6284-40-8

EC No. : 228-506-9

Appearance/Description: White to faintly yellowish-white, odourless crystalline powder

Molecular Formula: C7H17NO5

Molecular Mass: 195.2 g/mo

Marketed Formulation

  • Gadopentetate dimeglumine injection
  • Delafloxacin injection
  • Lansoprazole injection
  • Amlodipine besylate and Telmisartan tablets
  • Repaglinide tablets
  • Telmisartan tablets and many more

Quality and Regulatory Support

  • GMP and ISO certification
  • EXCiPACT certification
  • Nitrosamine impurity risk assessment
  • Elemental impurity risk assessment
  • Residual solvent declaration
  • Genotoxic impurity declaration
  • Vendor questionnaire and site audit
  • CMC documentation
  • Regulatory queries

Key Product Attributes

  • Manufacturing and packing under GMP environment
  • Low Endotoxin suitable for parenteral application
  • Control of TAMC & TYMC
  • Control of elemental impurities as per ICH Q3D

Pack Mode

  • Parenteral grade: 500 gm and 5 kg HDPE container
  • Non-Parenteral grade: 500 gm, 5 kg and 25 kg HDPE container

Pharmaceutical Specifications

Particulars Limit
Appearance / Description White to faintly yellowish-white, odourless crystalline powder (USP, Ph. Eur, BP, Ch. P)
Solubility Freely soluble in water, sparingly soluble in alcohol. Practically insoluble in dichloromethane and trichloromethane (USP, Ph. Eur, BP, Ch. P)
Identification (By chemical test 1) The mixture turns bright yellow and becomes clear (USP, Ph. Eur, BP)
Identification A (By IR) The IR absorption spectra of a substance should be concomitant with the corresponding standard (BP, Ph. Eur)
Identification (By chemical test 2) Silver mirror should form (Ch. P)
Identification (By chemical test 3) Initial brown, red precipitate appears, and then it is dissolved into a brown, red solution (Ch. P)
Identification (By chemical test 4 Yellow-green precipitate should form (Ch. P)
Completeness and colour of the solution The absorbance is not more than 0.030 (USP)
Appearance of solution The solution is clear, and its absorbance is not more than 0.030 (USP, Ph. Eur, BP, Ch. P)
Melting Range Between 128°C and 132°C (USP)
Melting Point About 128 (BP, Ph. Eur)
Specific rotation Between 15.7° and 17.3° (USP)
Specific optical rotation (Dried substance) Between -16.0 to -17.0 (BP, Ph. Eur)
Loss on drying Not more than 1.0% (USP)
Loss on drying, 105°C 3hr 0.5 % max. (BP, Ph. Eur, Ch. P)
Residue on ignition Not more than 0.1% (USP, Ch. P)
Heavy metals Not more than 10 ppm (Ch. P)
Sulfated ash 0.1 % max. (BP, Ph. Eur)
Reducing substances 0.2% max. as glucose (BP, Ph. Eur, Ch. P)
Assay 99.0 % - 101 % of C7H17NO5 on the dried basis (BP, Ph. Eur)
Chloride 100 ppm max. (BP, Ph. Eur)
Sulphate 150 ppm max. (BP, Ph. Eur)
Aluminium 5 ppm max. (BP, Ph. Eur)
Iron 10 ppm max. (BP, Ph. Eur)
Nickel 5 ppm max. (BP, Ph. Eur, Ch. P)
Arsenic NMT 1 ppm (Ch. P)
Related substances: Single impurity: NMT 0.25% (Ch.P)
Related substances: Total impurity: NMT 0.5% (Ch.P)
Residual Solvents (Methanol) Not more than 3000 ppm (USP, Ph. Eur, BP)
Absence of reducing substances The colour of the solution does not change (USP)
Assay 99.0% - 100.5% on the dried basis (USP)
Total aerobic microbial count NMT 100 CFU/g (In-house)
Total combined yeast and molds count NMT 10 CFU/g (In house)
Bacterial endotoxins NMT 1.5 IU/g (In-house)

Stability and Storage Conditions

Observe standard precautions appropriate to the circumstances and quantity of material handled. Meglumine should be handled in a well-ventilated environment. Eye protection, gloves and a respirator are recommended while handling the material. Exposure to meglumine dust should be kept below 10 mg/m3 for total inhalable dust (8-hour TWA) or 5 mg/m3 for respirable dust (8-hour TWA). There is a risk of explosion when meglumine dust is mixed with air.

Safety and Handling Information

Keep away from heat and sources of ignition. Empty containers pose a fire risk; evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing. In case of insufficient ventilation, wear appropriate respiratory equipment. If ingested, seek medical advice immediately and show the container or the label. Avoid contact with skin and eyes. Keep away from incompatibles such as oxidizing agents, moisture.

COA Product Catalogues Product Search Parenteral Applications
COA Product Catalogues Product Search Parenteral Applications