Ropivacaine Hydrochloride API is a pharmaceutical-grade amino-amide local anesthetic used in the development and manufacture of local and regional anesthetic preparations. The API is supplied as the S-(−) enantiomer in its hydrochloride monohydrate form and is characterized by high chemical purity, defined stereochemistry and established pharmacopoeial quality requirements.
Ropivacaine acts primarily by blocking sodium channels involved in the generation and conduction of nerve impulses, producing reversible local anesthesia. It is used in pharmaceutical formulations for infiltration anesthesia, nerve blocks and epidural anesthesia.
Ropivacaine Hydrochloride Monohydrate has the CAS number 132112-35-7, molecular formula C₁₇H₂₆N₂O·HCl·H₂O, and molecular weight 328.88 g/mol. It is described pharmacopoeially as (−)-(2S)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide hydrochloride monohydrate.
The API is a white or almost white crystalline powder. It is soluble in water and ethanol (96%) and slightly soluble in methylene chloride.
Ropivacaine Hydrochloride is the hydrochloride salt of the S-enantiomer of ropivacaine. Its defined stereochemistry is an important pharmaceutical quality attribute because the API is supplied as the enantiomerically pure S-form.
The compound belongs to the amide local-anesthetic class and has a pKa of approximately 8.07. At 25°C, reported aqueous solubility of the hydrochloride is 53.8 mg/mL.
Ropivacaine Hydrochloride is used in pharmaceutical formulations for local and regional anesthesia. Its applications include:
The finished drug product is supplied as sterile injectable solutions at different concentrations depending on the intended clinical application. These finished-product concentrations should not be confused with the API specification.
Ropivacaine Hydrochloride Monohydrate has established USP and Ph. Eur./BP quality standards. Identification can be performed by infrared spectroscopy and chloride testing, while assay is determined on an anhydrous basis.
Quality testing includes assay, related substances, enantiomeric purity, water, heavy metals, sulfated ash, pH and optical rotation. The pharmacopoeial impurity profile specifically controls bupivacaine, unspecified impurities, total impurities, 2,6-dimethylaniline and R-ropivacaine.
Manufacturing Ropivacaine Hydrochloride API requires controlled synthesis, purification and crystallization of the hydrochloride monohydrate. Particular attention is required for assay, stereochemical purity, related substances, water content and salt/hydrate form.
Analytical control using validated chromatographic, spectroscopic and physicochemical methods supports consistent pharmaceutical quality and batch-to-batch reproducibility.
Ropivacaine Hydrochloride should be packed in well-closed pharmaceutical containers that protect the crystalline API from environmental exposure.
USP specifies preservation in well-closed containers and storage at room temperature.
Typical Ropivacaine Hydrochloride API documentation may include:
Ropivacaine Hydrochloride Monohydrate is a well-characterized local-anesthetic API supported by established USP and Ph. Eur./BP quality requirements. Its defined S-stereochemistry, controlled impurity profile, specified water range and established analytical methods make it suitable for pharmaceutical manufacturing where consistent API quality is required.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5%–101.0% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.5–6.0 |
| Individual Impurity | NMT 0.20% |
| Total Impurities | NMT 0.50% |
| Water Content | 5.0%–6.0% |