Calcobutrol Powder Cas No.151878-23-8
Source: Synthetic
Purity: ≥98%
CAS No: 151878-23-8
Molecular Formula: C₁₈H36CaN₄O9
Molecular Weight: 492.58
Detection Method: HPLC
Active Ingredient: Calcobutrol
Characteristics: White to off-white crystalline powder, soluble in water
Packaging: 1g-10g/bottle (aluminum foil bag or brown glass bottle) (customizable)
Storage: Store at 2-8°C, protected from light and moisture
Shelf Life: 24 months
Declaration of Use: This product is intended for industrial use or scientific research only.
Calciobutrol (Calcobutrol) API Powder CAS 162527-38-0
Why Is Calciobutrol Crucial For Gadobutrol Injectable Stability?
1. Product Characterization & Formulation Value
Xi'an Tihealth supplies pharmaceutical-grade Calciobutrol API (also known as Calcobutrol Sodium, CAS 162527-38-0), a neutral, macrocyclic calcium coordination complex. Chemically, it represents the neutral calcium salt of the macrocyclic ligand butrol. In diagnostic parenterals, Calciobutrol serves as a designated formulation excipient and regulatory safety buffer in commercial Gadobutrol (1.0 mmol/mL) MRI contrast media.
Synthesized under rigid cGMP protocols, our material provides a highly uniform crystalline profile with low residual moisture (KF ≤ 5.0%) and controlled free calcium ions. Freely soluble in aqueous systems, this raw material protects generic manufacturers against trace heavy-metal transmetallation, post-sterilization precipitation, and raw ligand instability across commercial batch scales.
2. Technical Data Sheet (TDS) & Specifications
| Quality Parameter | Pharmaceutical Specification Standard (EP / USP) |
|---|---|
| Chemical Nomenclature | Calcium complex of 10-(1-hydroxymethyl-2,3-dihydroxypropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetic acid |
| Assay / Purity (HPLC) | ≥ 99.0% (Anhydrous Basis) |
| Related Substances / Impurities | Individual Impurity ≤ 0.10%; Total Impurities ≤ 0.50% |
| Physical Appearance | White or almost white crystalline hygroscopic powder |
| Identification | Conforms to reference spectra (1H-NMR, MS, FT-IR) |
| Water Content (Karl Fischer) | ≤ 5.0% |
| Free Calcium (Ca2+) | ≤ 0.20% (Strictly controlled within pharmaceutical limits) |
| Residual Solvents (ICH Q3C) | Ethanol ≤ 5000 ppm; Methanol ≤ 3000 ppm; Acetonitrile ≤ 410 ppm |
| Heavy Metals (ICP-MS) | ≤ 10 ppm total (Pb, Cd, As, Hg compliant) |
| Bacterial Endotoxins | ≤ 0.05 EU/mg (Suitable for sterile injectable processing) |
3. Coordination Chemistry & Stabilization Dynamics
Transmetallation Prevention
During processing and storage, GBCAs face risks of trace Gd3+ release induced by endogenous transition metals (such as Zn2+ or Cu2+). Formulating with excess Calciobutrol provides a thermodynamic safety reserve that exchanges non-toxic Ca2+ while capturing newly formed free gadolinium ions.
Serum Calcium Preservation
Excess uncoordinated macrocyclic free ligands in parenteral solutions deplete endogenous calcium upon rapid intravenous push. By providing the ligand pre-complexed with calcium in a 1:1 stoichiometry, formulation safety is preserved without disrupting physiological blood calcium levels.
High-Temperature Sterilization Stability
Gadobutrol 1.0 M formulations undergo terminal autoclaving at 121°C. Calciobutrol features high thermodynamic stability and exceptional water solubility, preventing ligand degradation, degradation-induced discoloration, and crystallization under high-temperature cycling.
4. Core Pharmaceutical Applications
- Generic Gadobutrol (Gadovist/Gadavist) Injectable Solutions: Formulated as a mandatory excess ligand stabilizer (typically 0.25% to 0.50% mol/mol relative to the active gadolinium chelate) to satisfy pharmacopeial stability mandates.
- Diagnostic Radiopharmaceutical R&D: Utilized in laboratory research to develop, evaluate, and stabilize next-generation macrocyclic chelating agents.
- Generic Formulation Bridging Studies: Serves as the essential reference stabilizer to demonstrate pharmacokinetic and clinical safety equivalence to brand-name contrast agents.
B2B REGULATORY & HANDLING PROTOCOLS
Calciobutrol is a hygroscopic chemical substance supplied strictly for B2B industrial formulation synthesis, pharmaceutical compound manufacturing, and laboratory research. Formulators must implement aseptic filling procedures and verify bacterial endotoxin limits on downstream clinical injectables.
5. Technical FAQ & Sourcing Inquiries
Why does Gadobutrol require Calciobutrol instead of plain calcium salts?Hot Tags: calcobutrol powder cas no.151878-23-8, China calcobutrol powder cas no.151878-23-8 manufacturers, suppliers, factory, hialuronato de sodio hialuronato sodico sodium hyaluronate, , ,
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