Opipramol API is a synthetic pharmaceutical active ingredient belonging to the dibenzazepine family and is pharmacologically classified as an anxiolytic with tricyclic antidepressant characteristics. It is chemically distinct from conventional tricyclic antidepressants because its pharmacological profile includes interaction with sigma receptors in addition to effects associated with other neurotransmitter systems. Opipramol has been used in pharmaceutical preparations primarily for the management of anxiety-related and psychosomatic disorders in markets where it is approved.
The chemical name of Opipramol is 2-[4-(3-benzo[b][1]benzazepin-11-ylpropyl)piperazin-1-yl]ethanol, according to PubChem. The free-base form has the molecular formula C23H29N3O and a molecular weight of 363.5 g/mol. Its CAS Registry Number is 315-72-0. NIST independently reports a molecular weight of 363.4959 g/mol, supporting the identity data for the free base.
Opipramol contains a dibenzazepine structural framework linked through a propyl chain to a substituted piperazine moiety. The piperazine nitrogen carries a 2-hydroxyethyl group, contributing to the chemical and physicochemical characteristics of the molecule. PubChem identifies the substance with the InChIKey YNZFUWZUGRBMHL-UHFFFAOYSA-N and lists its XLogP3-AA value as 3.6 and topological polar surface area as 30 Ų.
The free base should be differentiated from Opipramol Hydrochloride / Opipramol Dihydrochloride. PubChem identifies the hydrochloride material with CAS 909-39-7, molecular formula C23H31Cl2N3O, and molecular weight 436.4 g/mol. The hydrochloride is therefore not interchangeable with the free-base API when preparing specifications, regulatory documentation, product listings or pharmaceutical formulations.
The manufacture of Opipramol API requires controlled synthetic processing followed by purification and comprehensive analytical testing. As a chemically synthesized small-molecule API, quality control generally focuses on confirmation of chemical identity, assay, chromatographic purity, related substances, residual solvents, water content, elemental impurities and other applicable quality attributes.
A suitable Opipramol API manufacturing process should use controlled raw materials and validated reaction conditions to achieve consistent chemical conversion and impurity control. Downstream purification is important because process-related impurities, degradation products and residual solvents must be controlled according to the applicable finished-product or API specification.
For commercial pharmaceutical development, the exact analytical acceptance criteria should be based on the applicable pharmacopoeial monograph, registered product specification or validated manufacturer specification. Numerical limits should not be assumed where a universally applicable pharmacopoeial value cannot be verified.
Accurate identification is particularly important because Opipramol exists as both the free base and hydrochloride/dihydrochloride form. The free base is associated with CAS 315-72-0, while the hydrochloride/dihydrochloride form is associated with CAS 909-39-7. PubChem lists the free base under UNII D23ZXO613C and the hydrochloride under UNII B49OBI656M.
For an Opipramol API product page, the salt form should therefore be stated explicitly. This prevents confusion between the molecular weight of the free base and that of the hydrochloride material and helps pharmaceutical companies evaluate the correct raw material for their formulation or development program.
Opipramol has been investigated and used in pharmaceutical contexts involving anxiety disorders, depressive disorders and psychosomatic conditions. PubChem records clinical and research associations with anxiety disorders, depression, schizophrenia, dementia and psychosomatic disorders.
Pharmacologically, Opipramol is commonly described as an anxiolytic and tricyclic antidepressant-like compound. Its activity differs from classical tricyclic antidepressants, and its sigma-receptor interaction is an important part of its pharmacological characterization.
For API documentation, it is preferable to describe these applications objectively and avoid presenting the API itself as a treatment recommendation. The actual therapeutic use, dosage and indications depend on the approved medicinal product and applicable regulatory jurisdiction.
Quality control for Opipramol API can involve several analytical techniques. Identification may be established using spectroscopic techniques such as infrared spectroscopy, while chromatographic methods can be used to determine assay and related substances. Additional testing may include residual-solvent analysis, water determination and elemental impurity assessment where applicable.
Because Opipramol is a small-molecule organic compound, parameters such as molecular weight, chemical identity, chromatographic purity and impurity profile are directly relevant to API characterization. However, individual numerical limits for assay, impurities, residual solvents and other release parameters should only be published when supported by a current applicable standard or validated product specification.
This approach is especially important for pharmaceutical websites because presenting an arbitrary numerical specification as a universal Opipramol API requirement could create technical or regulatory inaccuracies.
Opipramol Hydrochloride, also referred to in chemical databases as Opipramol Dihydrochloride, is a salt form of the Opipramol active moiety. PubChem lists its molecular formula as C23H31Cl2N3O, molecular weight 436.4 g/mol, and CAS number 909-39-7. Its IUPAC name is reported as 2-[4-(3-benzo[b][1]benzazepin-11-ylpropyl)piperazin-1-yl]ethanol;dihydrochloride.
This distinction is valuable for pharmaceutical procurement and technical documentation because a product page titled “Opipramol API” may otherwise be interpreted as either the free base or salt. The intended form should always be specified in the certificate of analysis, specification sheet, technical package and commercial documentation.
Opipramol is a specialized pharmaceutical active ingredient with established chemical identifiers and a well-defined small-molecule structure. The free base has a molecular weight of approximately 363.50 g/mol, while Opipramol Dihydrochloride has a molecular weight of approximately 436.4 g/mol.
An Opipramol API manufacturer in India should maintain appropriate controls for raw materials, synthesis, purification, impurity management and final analytical testing. For pharmaceutical customers, technical documentation should clearly identify the chemical form, CAS number, molecular formula, molecular weight, analytical methods and applicable specification.
With accurate chemical identification and appropriately controlled quality attributes, Opipramol API can be documented for pharmaceutical development and manufacturing applications while maintaining a clear distinction between the free-base and hydrochloride forms.
| 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% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |