Key Properties of Tadalafil
| Product Name: | Tadalafil |
| Synonyms: | (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione |
| CAS No: | 171596-29-5 |
| Chemical Formula: | C₂₂H₁₉N₃O₄ |
| Grade: | USP/BP |
| Appearance: | White to off-white crystalline powder |
| Molar Mass: | 389.4 g/mol |
| Solubility: | Insoluble in water, but it is soluble in organic solvents such as ethanol and dimethyl sulfoxide (DMSO) |
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BroucherManufacturing process of Tadalafil
Prior to starting the process, confirm the cleanliness of equipment, availability of utilities, and presence of raw materials and packing materials.
The process begins with the addition of a solvent, such as acetone, into the reactor, followed by the charging of the starting materials and reagents for cyclization. The reaction is heated to 50–60°C and maintained for 360–480 minutes, Take in-process sample from reactor and send in-process sample to quality control (QC) for reaction monitoring by HPLC.
After the reaction, the mixture is cooled to 0–5°C, and an anti-solvent is added to crystallize the product. The crystals are filtered and washed with chilled anti-solvent, and the product is dried under vacuum at 40–50°C for 480–600 minutes.
Pack Tadalafil in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Tadalafil in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Tadalafil
Technical Specifications of Tadalafil
| Sr.No. | Test | Specification |
|---|---|---|
| 01 | Description | White powder or almost white powder |
| 02 | Solubility | Practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride |
| 03 | Identification By IR | The infrared absorption spectrum of the potassium bromide dispersion of the sample preparation should exhibit maxima only at the same wave numbers as that of a similar preparation of tadalafil working standard. |
| 04 | Identification By HPLC | The retention time of the major peak of the sample solution should correspond to that of the identification solution as obtained in the test for enantiomeric and diastereomeric purity. |
| 05 | Organic Impurity By HPLC (%w/w) | Individual Impurity: Not more than 0.1% Total Impurities: Not more than 0.3% |
| 06 | Enantiomeric and Diastereomeric Purity (% HPLC) | 6R,12aS Diastereomer: Not more than 0.1% 6S,12aS Enantiomer: Not more than 0.1% 6S,12aR Diastereomer: Not more than 0.1% |
| 07 | Loss on Drying in Vacuum at 105°C for 3 hrs (%w/w) | Not more than 0.5% |
| 08 | Residue on Ignition (%w/w) | Not more than 0.1% |
| 09 | Assay By HPLC on Dried Basis (%w/w) | Not less than 97.5% and not more than 102.5% |
Packing and Storage condition of Tadalafil
Pack Tadalafil in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Tadalafil in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Tadalafil Supply?
Quality Assurance
Grade Compliance
Tadalafil 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
Tadalafil 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.
