Oxyphencyclimine is a synthetic anticholinergic and antimuscarinic pharmaceutical compound belonging to the tertiary amine class. The pharmaceutical material is commonly encountered as Oxyphencyclimine Hydrochloride, the hydrochloride salt of oxyphencyclimine. Oxyphencyclimine acts primarily as a muscarinic acetylcholine receptor antagonist and has historically been associated with gastrointestinal antispasmodic and antisecretory applications.
Oxyphencyclimine free base has the molecular formula C₂₀H₂₈N₂O₃, molecular weight approximately 344.45 g/mol, and CAS Number 125-53-1. Its hydrochloride form has the formula C₂₀H₂₉ClN₂O₃, CAS Number 125-52-0, and molecular weight 380.909 g/mol. These identities are supported by chemical databases and NIST reference data.
Oxyphencyclimine Hydrochloride is a solid pharmaceutical substance generally described as a white to off-white material. NIST identifies the hydrochloride with molecular formula C₂₀H₂₉ClN₂O₃ and molecular weight 380.909 g/mol. NIST's evaluated infrared reference data also reports a melting point of approximately 231–232°C with decomposition.
The hydrochloride is formed by combining the tertiary amine free base with hydrochloric acid. As a salt form, its physicochemical characteristics differ from those of the free base and should therefore be represented separately in API documentation.
Oxyphencyclimine is classified as an antimuscarinic / anticholinergic agent. Its pharmacological action involves antagonism of muscarinic acetylcholine receptors. Historical pharmaceutical use included treatment associated with peptic ulcer disease, gastrointestinal spasms and excessive gastrointestinal secretion.
The compound is listed in chemical and drug databases as a muscarinic receptor antagonist. The free base is also identified with PubChem CID 4642 and ChEBI CHEBI:7868.
Oxyphencyclimine has historically been used as an oral anticholinergic and gastrointestinal antispasmodic. Its pharmacological profile has been associated with reduction of smooth-muscle activity and gastrointestinal secretions.
Potential pharmaceutical and research applications include:
Historical information identifies oxyphencyclimine hydrochloride as an anticholinergic agent used as an adjunct in peptic-ulcer therapy and for relief of smooth-muscle spasms.
The free-base structure is represented by the IUPAC name:
(1-Methyl-1,4,5,6-tetrahydropyrimidin-2-yl)methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate
The hydrochloride is the corresponding hydrochloride salt. NIST records the hydrochloride as C₂₀H₂₉ClN₂O₃ with molecular weight 380.909 g/mol and CAS 125-52-0.
The free base has molecular formula C₂₀H₂₈N₂O₃ and calculated molecular weight approximately 344.44–344.45 g/mol.
For pharmaceutical-grade Oxyphencyclimine Hydrochloride, quality evaluation should cover identity, assay, related substances, residual solvents, water or loss on drying, inorganic residue and other applicable quality attributes according to the approved product specification.
Because a current authoritative numerical USP/IP API release specification could not be verified from publicly accessible primary sources during this research, numerical acceptance criteria for assay, individual impurities, total impurities, LOD and heavy metals should not be presented as universal pharmacopoeial values.
This distinction is important for a CMS product page because commercially available laboratory/reference materials can have purity specifications that are not equivalent to an official pharmaceutical API monograph.
Oxyphencyclimine Hydrochloride can be identified using spectroscopic and chromatographic techniques. NIST provides an evaluated infrared spectrum for the hydrochloride, making IR identification an appropriate identity technique.
For pharmaceutical release testing, identity can additionally be supported by chromatographic retention time against a qualified reference standard. Depending on the customer's approved specification, HPLC or another validated chromatographic procedure can be used for assay and related-substance determination.
The hydrochloride is a solid with reported melting/decomposition behavior around 231–232°C. NIST specifically reports 231–232°C, decomposition in its reference spectrum record.
The compound should be handled using suitable pharmaceutical raw-material controls, with protection from excessive moisture and heat. Historical chemical information notes that oxyphencyclimine hydrochloride can undergo hydrolysis in the presence of excessive moisture and heat.
Oxyphencyclimine API manufacturing requires controlled synthesis, purification and analytical characterization appropriate for the intended pharmaceutical application. The final API should be released against an approved specification covering chemical identity, potency, purity and relevant physical and chemical attributes.
For API documentation, it is especially important to distinguish Oxyphencyclimine from Oxyphencyclimine Hydrochloride because their CAS numbers and molecular weights are different.
Oxyphencyclimine: CAS 125-53-1, C₂₀H₂₈N₂O₃, MW approximately 344.45 g/mol.
Oxyphencyclimine Hydrochloride: CAS 125-52-0, C₂₀H₂₉ClN₂O₃, MW 380.909 g/mol.
This distinction helps pharmaceutical manufacturers, formulation developers and analytical laboratories select the correct material and reference standard.
| 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 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Melting Point | 231–232°C, decomposes |