Melphalan Hydrochloride (Melphalan HCl) is the hydrochloride salt form of melphalan, a nitrogen mustard alkylating agent used as an antineoplastic pharmaceutical compound. Melphalan belongs to the class of bifunctional alkylating agents and is structurally related to phenylalanine.
Melphalan produces its anticancer activity primarily through DNA alkylation and cross-linking, which interferes with DNA replication and transcription and can lead to cell death.
Melphalan Hydrochloride is associated with the molecular formula C13H19Cl3N2O2 and an approximate molecular weight of 341.66 g/mol for the anhydrous hydrochloride form. The parent melphalan has CAS Number 148-82-3.
The hydrochloride salt is used to modify the physicochemical properties of the parent active compound and may be encountered in pharmaceutical development and formulation contexts.
Melphalan HCl acts as an alkylating agent. Its nitrogen mustard group can form covalent bonds with nucleophilic sites in DNA.
This results in DNA cross-linking and damage, inhibiting DNA replication and transcription. The resulting cellular damage contributes to the cytotoxic activity of melphalan against susceptible rapidly dividing cells.
Melphalan is used in pharmaceutical oncology applications, particularly in the treatment of multiple myeloma and selected malignancies.
Applications may include:
The approved use depends on the specific formulation, route, strength and regulatory jurisdiction.
Melphalan HCl can be evaluated using validated analytical procedures for identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
HPLC and spectroscopic techniques may be used for identification, assay and impurity profiling. Because melphalan is a cytotoxic alkylating compound, appropriate controls for degradation products, process-related impurities and occupational exposure are important.
Final release criteria should be established according to the applicable manufacturer's approved specification and Certificate of Analysis.
Melphalan HCl should be stored in a tightly closed pharmaceutical-grade container under controlled conditions and protected from excessive heat, moisture and light.
As a cytotoxic pharmaceutical substance, handling and storage should follow applicable hazardous-drug and occupational-safety procedures.
Melphalan HCl may be supplied for qualified pharmaceutical manufacturing, formulation development, analytical and research applications, subject to applicable regulatory and quality requirements.
Melphalan HCl API is available for qualified pharmaceutical development and manufacturing requirements. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 5.0% |