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Phenylephrine Hydrochloride is a selective α1-adrenergic receptor agonist used as a nasal decongestant, vasopressor, and mydriatic agent. It is widely utilized in formulations to relieve nasal congestion, sinus pressure, and hypotensive conditions during anesthesia.
At Bluepill Express, we manufacture and export high-purity Phenylephrine Hydrochloride API that conforms to IP, BP, USP, and EP standards. Our API features excellent solubility, high assay value, and low impurity content, ensuring superior performance in pharmaceutical formulations worldwide.
Therapeutic Uses
- Nasal decongestant for colds, flu, and sinusitis
- Vasopressor for management of hypotension during anesthesia
- Ophthalmic mydriatic for pupil dilation during eye examinations
- Component in cold and cough combination formulations
- Treatment of allergic rhinitis and sinus congestion
Mechanism of Action
Phenylephrine Hydrochloride acts primarily on α1-adrenergic receptors, producing vasoconstriction of blood vessels in nasal mucosa and peripheral tissues. This action results in:
- Reduction of nasal congestion and swelling
- Increase in blood pressure (when used as a vasopressor)
- Pupil dilation (in ophthalmic formulations)
Unlike epinephrine, Phenylephrine has minimal β-adrenergic activity, resulting in fewer cardiac side effects.
Pharmacological Information
- Chemical Name: (R)-3-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride
- Molecular Formula: C9H13NO2·HCl
- Molecular Weight: 203.67 g/mol
- CAS Number: 61-76-7
- Therapeutic Category: Nasal Decongestant / Vasopressor / Mydriatic
- Pharmacopoeial Standards: IP / BP / USP / EP
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White or almost white crystalline powder |
| Odor | Odorless |
| Taste | Slightly bitter |
| Melting Point | 143°C – 146°C |
| Solubility | Freely soluble in water and alcohol; practically insoluble in ether |
| pH (1% solution) | 4.5 – 6.5 |
| Assay (on dried basis) | 98.0% – 102.0% |
| Specific Rotation | +52° to +58° |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / UV / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Chloride Test | Complies with IP/BP/USP standards |
| Heavy Metals | ≤ 10 ppm |
| Storage Conditions | Store in a cool, dry, dark place, below 30°C |
Applications
- Cold and flu preparations (tablets, syrups, and nasal drops)
- Ophthalmic formulations (eye drops for pupil dilation)
- Parenteral vasopressor formulations
- Combination medicines with Paracetamol, Cetirizine, Chlorpheniramine, or Ibuprofen
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH compliant)
- DMF / Regulatory dossier available on request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
- Labeling: Product Name, Batch No., MFG/EXP Date, Net Weight, Storage Info
- Shelf Life: 5 years under recommended conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
