Pharmaceutical-Grade Phenylephrine Hydrochloride for Pharmaceutical Formulations
Phenylephrine HCl, also known as Phenylephrine Hydrochloride, is a pharmaceutical-grade ingredient used in the development and manufacture of suitable pharmaceutical formulations. It is identified by CAS Number 61-76-7, molecular formula C₉H₁₄ClNO₂, and molecular weight approximately 203.66 g/mol. PubChem describes Phenylephrine Hydrochloride as an odorless white microcrystalline powder.
Phenylephrine Hydrochloride is the hydrochloride salt form of phenylephrine and is supplied as a pharmaceutical ingredient for formulation and manufacturing applications. The USP monograph defines Phenylephrine Hydrochloride as containing 98.0%–102.0% of Phenylephrine Hydrochloride, calculated on the dried basis.
Phenylephrine HCl can be used as an active ingredient in suitable pharmaceutical formulations, including:
USP separately recognizes Phenylephrine Hydrochloride in dosage-form monographs including tablets, ophthalmic solution, injection and nasal solution, demonstrating its use across different pharmaceutical dosage forms.
Phenylephrine HCl can be evaluated using identification, assay, related-substance and physical-property testing according to the applicable pharmacopoeial specification.
The USP monograph specifies an assay of 98.0%–102.0% on the dried basis. USP also identifies reference standards for Phenylephrine Hydrochloride and several related compounds for analytical testing.
Phenylephrine HCl can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing requirements. Packaging configuration, quantity, storage conditions and quality documentation should be confirmed according to the applicable product specification and customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 5.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |