Tegileridine Fumarate API is the fumarate salt of tegileridine, a synthetic small-molecule μ-opioid receptor agonist developed for analgesic use. Tegileridine has three defined stereocenters and the molecular formula of the active moiety is C₂₈H₃₈N₂O₂, with a molecular weight of 434.61 g/mol. Tegileridine fumarate has the molecular formula C₂₈H₃₈N₂O₂·C₄H₄O₄ and molecular weight of approximately 550.70 g/mol.
Tegileridine fumarate is documented as a 1:1 salt of tegileridine and fumaric acid. The FDA substance database identifies tegileridine fumarate as the salt/solvate related to tegileridine as its active moiety.
Tegileridine is a stereochemically defined small molecule containing a tetrahydronaphthalene system, pyridine ring and oxaspirocyclic structure. The compound has three defined stereocenters. PubChem reports the active moiety molecular formula as C₂₈H₃₈N₂O₂ and molecular weight as 434.6 g/mol.
Tegileridine acts as a μ-opioid receptor agonist. Published pharmacological literature describes it as a μ-opioid receptor biased agonist designed to preferentially activate G-protein signaling while producing comparatively weaker β-arrestin-2 pathway activation.
Tegileridine fumarate has been developed for analgesic applications. China’s National Medical Products Administration approved Tegileridine Fumarate Injection for the treatment of moderate-to-severe pain following abdominal surgery.
The approved injection is supplied in strengths including 1 mg/mL and 5 mg/5 mL, expressed in terms of tegileridine active moiety.
Tegileridine Fumarate API should be evaluated using validated analytical procedures appropriate for a stereochemically defined small-molecule drug substance. Typical quality-control testing can include:
Because publicly available sources do not establish a universal pharmacopoeial numerical release specification for Tegileridine Fumarate API, product-specific limits should be based on the applicable approved specification and validated analytical methods rather than unsupported generic limits.
Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for research, development and commercial pharmaceutical requirements. Tegileridine Fumarate is handled as a stereochemically defined small-molecule API, with quality controls designed around identity, assay, purity, stereochemical integrity and other applicable drug-substance attributes.
Tegileridine Fumarate API should be packed in suitable pharmaceutical-grade, well-closed packaging that protects the material from moisture, contamination and unsuitable environmental exposure.
Storage conditions should follow the validated product specification and stability data. Recommended handling should maintain the API in a controlled, dry environment and protect it from excessive heat, moisture and direct light.
Depending on the supply and customer requirement, relevant pharmaceutical documentation may include:
Swapnroop Drugs and Pharmaceuticals focuses on quality-oriented pharmaceutical API manufacturing and analytical control. For Tegileridine Fumarate, emphasis is placed on chemical identity, assay, chromatographic purity, stereochemical quality and appropriate documentation for pharmaceutical development and manufacturing requirements.
Swapnroop Drugs and Pharmaceuticals — quality-focused API manufacturing from India.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |