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SILDENAFIL CITRATE

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Sildenafil Citrate is a phosphodiesterase type 5 (PDE5) inhibitor used primarily in the treatment of erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). It works by enhancing blood flow to specific areas of the body, particularly the penis, through the relaxation of vascular smooth muscles.

At Bluepill Express, we manufacture and export high-purity Sildenafil Citrate API compliant with IP, BP, USP, and EP pharmacopeial standards. Our product is produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities ensuring unmatched quality, purity, and consistency suitable for pharmaceutical formulations, tablets, and capsules.

Our Sildenafil Citrate is micronized for optimal bioavailability and dissolution, ensuring maximum therapeutic efficacy in finished dosage forms like film-coated tablets (25 mg, 50 mg, 100 mg) and oral jellies.

Pharmacological Information:

  • Category: PDE5 Inhibitor
  • Therapeutic Class: Erectile Dysfunction, Pulmonary Hypertension
  • CAS Number: 171599-83-0
  • Molecular Formula: C22H30N6O4S
  • Molecular Weight: 474.58 g/mol
  • Appearance: White to off-white crystalline powder
  • Solubility: Slightly soluble in water, freely soluble in dimethyl sulfoxide (DMSO) and methanol
  • Melting Point: 187°C – 190°C
  • Storage: Store below 25°C in a dry, cool place away from direct sunlight

Mode of Action:

Sildenafil Citrate works by inhibiting the PDE5 enzyme, which is responsible for the breakdown of cyclic guanosine monophosphate (cGMP). Increased cGMP levels lead to smooth muscle relaxation and vasodilation, resulting in improved blood flow to the penile tissues and sustained erection in response to sexual stimulation. It also helps reduce pulmonary arterial pressure by relaxing vascular walls in the lungs.

Applications and Uses:

  • Erectile Dysfunction Treatment – Enhances erectile response in men by increasing penile blood flow.
  • Pulmonary Arterial Hypertension (PAH) – Reduces pulmonary vascular resistance and improves exercise capacity.
  • Sexual Health Supplements – Used in combination products and herbal formulations for men’s wellness.

Technical Specifications:

  • Assay (Purity): ≥ 99.5%
  • Identification: IR spectrum complies with reference standard
  • Loss on Drying: ≤ 0.5%
  • Residue on Ignition: ≤ 0.1%
  • Heavy Metals: ≤ 10 ppm
  • Related Substances: ≤ 0.1% (individual impurity)
  • Microbial Limits: Complies with pharmacopeial standards

Manufacturing & Quality Assurance – Bluepill Express:

  • Manufactured under WHO-GMP & ISO-certified conditions
  • Micronized grade available for rapid dissolution and uniform blending
  • COA, MSDS, and TDS available with every shipment
  • Suitable for pharmaceutical, nutraceutical, and research formulations
  • Pharmacopeial compliance: IP / BP / USP / EP

Packaging & Export Details:

  • Available Packaging: 1 kg, 5 kg, 10 kg HDPE drums with double-layer LDPE inner liner
  • Shelf Life: 36 months from manufacturing date
  • Export Markets: Africa, Latin America, Europe, Middle East, and Asia
  • Documentation Provided:
    • Certificate of Analysis (COA)
    • Material Safety Data Sheet (MSDS)
    • Technical Data Sheet (TDS)
    • Non-GMO Declaration
    • Free Sale Certificate (if required)

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