Phenylephrine Hydrochloride

Phenylephrine Hydrochloride (CAS 61-76-7)

Reliable Bulk Supply for Regulated Pharma Markets

What Is Phenylephrine Hydrochloride (CAS 61-76-7) Used For in Pharmaceuticals?

Phenylephrine Hydrochloride is a pharmaceutically active compound classified as a selective α₁‑adrenergic receptor agonist, widely recognized for its role in decongestant, vasopressor, and mydriatic formulations. As a hydrochloride salt, it offers enhanced solubility, stability, and formulation compatibility, making it ideal for inclusion in oral tablets, injectable ampoules, and ophthalmic drops.

In B2B pharmaceutical procurement, Phenylephrine HCl is a critical API sourced for regulated drug formulations, particularly in the production of over-the-counter (OTC) cold and allergy medications, hemodynamic support agents, and eye-care solutions. Its pharmacodynamic precision and long-established safety profile make it a preferred molecule among generic drug manufacturers, CMOs, and hospital pharmacy networks worldwide.

Pharmint offers this API with full documentation support—COA, MSDS, USP/EP compliance, and optional DMF/CEP access—ensuring smooth onboarding into validation workflows, product registration dossiers, and global supply chains.

Why Should B2B Buyers Choose Pharmint for Phenylephrine HCl Supply?

Pharmint provides GMP-compliant, pharmacopeia-grade API with global export readiness, documentation support, and consistent quality assurance—tailored for CDMOs, CMOs, and pharma manufacturers.

What Industries and Use Cases Benefit from Bulk Phenylephrine HCl?

• OTC Manufacturers: For cold/cough medicines
• API Exporters: With regulatory dossiers for CEP/DMF
• Hospital Buyers: For injectable pressor agents
• Ophthalmic Drug Producers: For diagnostic and surgical formulations

What Are the Technical and Compliance Specifications?

How Does Pharmint Ensure Regulatory and Documentation Readiness?

We provide auditable GMP documentation, batch COAs, and impurity profiles aligned with ICH Q7 and pharmacopeial monographs. Export licenses and end-use declarations are managed in compliance with country-specific regulations.

What Are the Supply Chain and Sourcing Advantages?

• Bulk inventory for short lead time
• Global reach with customs support
• Dedicated account managers for strategic sourcing
• Support for tech transfer, validation, and dossier filing

How Can I Request Pricing, Samples, or a Regulatory File?

Reach out for a custom quote, batch documentation, or product registration file. We support pilot batch delivery, MOQ flexibility, and long-term supply contracts.

Phenylephrine HCl FAQs 

What documents are needed to import Phenylephrine HCl for formulation use?

Importers must present COA, MSDS, and often a valid DMF or CEP along with an end-use declaration, as regulated agencies predicate substance control on final formulation intent.

Can Phenylephrine Hydrochloride be used in combination drug formulations?

Yes, Phenylephrine HCl is commonly formulated with antihistamines or NSAIDs; regulatory authorities predicate combination drug approval on bioequivalence and compatibility studies.

How is Phenylephrine HCl stability ensured during storage and transit?

Stability is maintained when stored in sealed, light-resistant packaging at 2–8 °C; GMP protocols predicate cold-chain logistics on integrity of batch ID and moisture control.

Does Pharmint provide validation or reference standard support?

Pharmint supplies validation-grade API with HPLC data, impurity profiles, and reference standards when requested, supporting predicate analytical method development in QC labs.

What export restrictions apply to Phenylephrine HCl?

While not universally controlled, exports predicate licensing on country-specific pharmaceutical regulations and may require end-user declarations for customs clearance.