Enclomiphene 12.5mg – 30 Capsules

Analytical and Formulation Documentation of Enclomiphene 12.5 mg Capsules

Enclomiphene 12.5 mg is a defined chemical entity formulated into oral capsules intended for research and laboratory use. This document provides a detailed overview of its physicochemical properties, formulation parameters, batch characterization, analytical testing methodologies, and quality-control documentation practices. The content is presented in a strictly neutral, research-use-only (RUO) context, without clinical or therapeutic implications. Enclomiphene is a non-steroidal compound classified chemically as a selective estrogen receptor modulator (SERM) isomer. The 12.5 mg strength refers to the nominal amount of active enclomiphene citrate per capsule. Physicochemical characterization includes molecular weight determination, melting point range, solubility profile, and spectral analysis data such as ultraviolet-visible (UV-Vis) absorption and nuclear magnetic resonance (NMR) spectroscopy. These parameters are essential for confirming compound identity and consistency across production batches.Typical physicochemical properties documented for enclomiphene citrate include:Molecular formula: C26H28ClNOMolecular weight: Approximately 405.96 g/molAppearance: White to off-white crystalline powderSolubility: Sparingly soluble in water; soluble in organic solvents such as ethanol and methanolMelting point: Characteristic range determined by differential scanning calorimetry (DSC) The 12.5 mg enclomiphene capsules are formulated using pharmaceutical-grade excipients selected for compatibility and stability. Capsule composition typically includes the active compound blended with inert fillers, flow agents, and capsule shell materials compliant with laboratory standards.Batch characterization involves rigorous documentation of raw material sourcing, in-process controls, and final product testing. Each batch undergoes verification to ensure uniformity of content, capsule weight variation within specified limits, and absence of contaminants or impurities beyond established thresholds.Key batch parameters include:Assay of active compound: Confirmed by high-performance liquid chromatography (HPLC) with ultraviolet detectionUniformity of dosage units: Evaluated according to pharmacopeial guidelinesIdentification tests: Spectroscopic and chromatographic methods to confirm chemical identityImpurity profiling: Quantification of related substances and degradation products Analytical testing protocols for enclomiphene 12.5 mg capsules are designed to ensure batch-to-batch consistency and compliance with quality standards. The primary analytical technique employed is HPLC, which provides quantitative determination of the active compound and detection of impurities.Additional analytical methods include:Mass spectrometry (MS): For molecular weight confirmation and impurity identificationNMR spectroscopy: For structural verificationInfrared (IR) spectroscopy: To assess functional groups and compound integrityThermogravimetric analysis (TGA): To evaluate thermal stabilityPurity specifications are established based on analytical data, with acceptance criteria defined for active compound concentration and impurity limits.

Compound Profile and Physicochemical Properties