Pharmaceutical-Grade Chlorpheniramine Maleate for Pharmaceutical Formulations
Chlorpheniramine Maleate is a pharmaceutical ingredient supplied for use in suitable oral pharmaceutical formulations. It is the maleate salt of chlorpheniramine and is identified by CAS Number 113-92-8, molecular formula C₂₀H₂₃ClN₂O₄ and molecular weight 390.9 g/mol. PubChem describes Chlorpheniramine Maleate as a white crystalline solid or white powder.
Chlorpheniramine Maleate is available as a pharmaceutical-grade material for formulation and manufacturing applications. The material can be evaluated using identification, assay, related-substance, loss-on-drying and residue-on-ignition testing according to the applicable pharmacopoeial specification.
The USP monograph specifies 98.0%–100.5% Chlorpheniramine Maleate calculated on the dried basis. USP also specifies a melting range of 130–135°C, loss on drying of not more than 0.5%, and residue on ignition of not more than 0.2%.
Chlorpheniramine Maleate can be used as an active pharmaceutical ingredient in suitable pharmaceutical formulations, including:
Chlorpheniramine Maleate quality can be evaluated through identity, assay, related substances, loss on drying and residue-on-ignition testing. The applicable specification should be selected according to the required pharmacopoeial standard and the actual material specification.
The USP reference specifies an assay range of 98.0%–100.5% on the dried basis. The BP monograph also controls specified impurities, unspecified impurities and total impurities, with total impurities limited to 0.5% in the cited BP specification.
Chlorpheniramine Maleate can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing requirements. Packaging quantity, storage conditions and documentation should be confirmed according to the applicable product specification and customer requirements.
The British Pharmacopoeia reference-standard catalogue identifies Chlorphenamine Maleate under CAS 113-92-8 and lists it as a quantitative reference material.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| pH (1% Solution) | 4.0–5.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |