Pharmaceutical-Grade Dextromethorphan for Pharmaceutical Formulations
Dextromethorphan is a pharmaceutical ingredient used in the development and manufacture of suitable oral pharmaceutical formulations. It is identified by CAS Number 125-71-3, molecular formula C₁₈H₂₅NO, and molecular weight 271.40 g/mol. The material is the dextrorotatory enantiomer of methorphan and is chemically distinct from Dextromethorphan Hydrobromide.
Dextromethorphan is available as a pharmaceutical-grade material for formulation development and manufacturing applications. The USP monograph defines Dextromethorphan as containing 98.0% to 101.0%, calculated on the anhydrous basis. USP also recognizes Dextromethorphan as a specific chemical entity separate from Dextromethorphan Hydrobromide.
Dextromethorphan can be incorporated into suitable pharmaceutical formulations according to the intended dosage form, formulation composition and applicable quality requirements. Product quality is evaluated through appropriate identification, assay and impurity-control procedures.
Dextromethorphan can be used as an active ingredient in suitable pharmaceutical formulations, including:
Dextromethorphan quality should be evaluated according to the applicable pharmacopoeial or approved product specification. Identification, assay and related-substance testing are important quality attributes for pharmaceutical-grade material.
The USP monograph specifies 98.0%–101.0% Dextromethorphan on the anhydrous basis. USP also identifies Dextromethorphan Reference Standard and Levomethorphan Solution Reference Standard for analytical testing.
Dextromethorphan 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%–101.0%, |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |