Key Properties of Sildenafil Citrate
| Product Name: | Sildenafil Citrate |
| Synonyms: | 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate |
| CAS No: | 171599-83-0 |
| Chemical Formula: | C₂₂H₃₀N₆O₄S·C₆H₈O₇ |
| Grade: | USP/BP |
| Appearance: | White to off-white crystalline powder |
| Molar Mass: | 666.7 g/mol |
| Solubility: | Practically insoluble in water, freely soluble in dimethyl sulfoxide (DMSO), slightly soluble in methanol |
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BroucherManufacturing process of Sildenafil Citrate
The production of Sildenafil Citrate API involves multiple chemical synthesis steps to ensure high purity and efficacy. Below is a general step-wise manufacturing process:
Step 1: Raw Material Selection & Preparation
- Select high-purity raw materials, including pyrazolo-pyrimidinone derivatives and other key intermediates.
- Ensure all raw materials meet GMP and ISO 9001 quality standards before synthesis.
Step 2: Condensation Reaction
- Perform a condensation reaction between key intermediates to form the base structure of Sildenafil.
- Control reaction parameters like temperature, pH, and reaction time to optimize yield.
Step 3: Cyclization Process
- Cyclization is carried out to form the core pyrazolopyrimidinone structure of Sildenafil.
- Use appropriate catalysts and solvents to drive the reaction to completion.
Step 4: Purification of Sildenafil Base
- Purify the crude Sildenafil using solvent extraction, crystallization, and filtration.
- Remove impurities and by-products to improve purity levels.
Step 5: Citrate Salt Formation
- Convert Sildenafil base into Sildenafil Citrate by reacting it with citric acid.
- Control pH and temperature to ensure proper salt formation and stability.
Step 6: Crystallization & Drying
- Crystallize Sildenafil Citrate under controlled conditions to obtain the desired particle size.
- Dry the product using vacuum drying or tray drying to remove residual solvents.
Step 7: Milling & Sieving
- Mill and sieve the dried Sildenafil Citrate to achieve uniform particle size distribution.
- Ensure compliance with pharmaceutical-grade specifications.
Step 8: Quality Control & Testing
- Conduct HPLC, FTIR, NMR, and other analytical tests to verify purity and potency.
- Check for residual solvents, heavy metals, and microbial contamination as per regulatory guidelines.
Step 9: Packaging & Storage
- Pack Sildenafil Citrate in airtight, moisture-resistant containers under nitrogen blanketing to prevent degradation.
- Store at a controlled temperature (below 30°C) in a dry environment.
Applications of Sildenafil Citrate
Technical Specifications of Sildenafil Citrate
| Sr. No. | Test | Specification |
|---|---|---|
| 01 | Description | White or almost white crystalline powder |
| 02 | Solubility | Freely soluble in dimethyl sulfoxide, slightly soluble in methanol, practically insoluble in water |
| 03 | Identification By IR | The infrared absorption spectrum of the sample should be concordant with that of the Sildenafil Citrate reference standard. |
| 04 | Identification By HPLC | The retention time of the major peak of the sample solution should correspond to that of the reference standard solution. |
| 05 | Organic Impurity By HPLC (%w/w) | Individual Impurity: Not more than 0.1% Total Impurities: Not more than 0.5% |
| 06 | Enantiomeric Purity (% HPLC) | R-enantiomer: Not more than 0.1% |
| 07 | Loss on Drying in Vacuum at 105°C for 3 hrs (%w/w) | Not more than 1.0% |
| 08 | Residue on Ignition (%w/w) | Not more than 0.1% |
| 09 | Assay By HPLC on Dried Basis (%w/w) | Not less than 98.0% and not more than 102.0% |
Packing and Storage condition of Sildenafil Citrate
Pack Sildenafil Citrate 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.
MSDS - Sildenafil Citrate
Why Choose Chemignition for
Sildenafil Citrate Supply?
Quality Assurance
Grade Compliance
Sildenafil Citrate 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
Sildenafil Citrate 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.
