Key Properties of Carboprost Tromethamine
| Product Name: | Carboprost Tromethamine |
| Synonyms: | 2-amino-2-(hydroxymethyl)propane-1,3-diol; (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(E,3S)-3-hydroxy-3-methyloct-1-enyl]cyclopentyl]hept-5-enoic acid |
| CAS No: | 58551-69-2 |
| Chemical Formula: | C₂₅H₄₇NO₈ |
| Grade: | USP/IH |
| Appearance: | White to off-white powder |
| Molar Mass: | 489.63 g/mol |
| Solubility: | Soluble in organic solvents such as ethanol, methanol, and dimethyl sulfoxide (DMSO), but it is practically insoluble in water |
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BroucherManufacturing process of Carboprost Tromethamine
Before initiating the Carboprost Tromethamine manufacturing process, equipment cleanliness is confirmed, and the availability of utilities, raw materials, and packing materials is verified.
The process begins by charging a suitable solvent like ethanol or methanol into a glass-lined reactor, followed by the addition of Carboprost acid under stirring. Tromethamine is then gradually added at a controlled temperature of 20–25°C, and the pH is adjusted using a suitable pH adjuster such as sodium hydroxide solution. The reaction is maintained at this temperature with continuous stirring for 240–360 minutes.
Once the reaction is complete, the mixture is cooled to 5–10°C to initiate crystallization, followed by 120–180 minutes of stirring to promote crystal growth. The crystallized product is filtered using a vacuum filtration system or centrifuge and washed with a chilled solvent to remove impurities. The wet product is then dried in a vacuum dryer at 30–40°C for 360–480 minutes.
Finally, Pack Carboprost Tromethamine in a glass or polypropylene vial. Place the vial inside a poly bag, twist its mouth, and secure it with a PVC strip. Insert this bag into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Carboprost Tromethamine in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
Applications of Carboprost Tromethamine
Technical Specifications of Carboprost Tromethamine
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White or almost-white, crystalline powder |
| 2 | Solubility | Freely soluble in methylene chloride |
| 3 | Identification (IR Spectroscopy) | IR spectrum matches USP Carboprost Tromethamine Reference Standard |
| 4 | Assay | 95.0% to 105.0% on a dried basis |
| 5 | Impurities – 5-trans Isomer | Not more than 3.0% |
| 6 | Loss on Drying | Not more than 0.5% (at 105°C for 3 hours) |
| 7 | Residue on Ignition | Not more than 0.1% |
| 8 | Specific Rotation | +15.5° to +17.5° |
| 9 | pH | 1% solution: pH 7.0 to 8.5 |
| 10 | Related Substances (Any Individual Impurity) | Not more than 0.5% |
| 11 | Related Substances (Total Impurities) | Not more than 1.0% |
Packing and Storage condition of Carboprost Tromethamine
Pack Carboprost Tromethamine in a glass or polypropylene vial. Place the vial inside a poly bag, twist its mouth, and secure it with a PVC strip. Insert this bag into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Carboprost Tromethamine in a tightly closed, light-resistant container at a temperature of -20°C to -10°C.
MSDS - Carboprost Tromethamine
Why Choose Chemignition for
Carboprost Tromethamine Supply?
Quality Assurance
Grade Compliance
Carboprost Tromethamine is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Carboprost Tromethamine is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
