Ropivacaine is an amide-type local anesthetic API used in pharmaceutical formulations for regional and local anesthesia. It belongs to the amino-amide class of local anesthetic compounds and is the S-enantiomer of ropivacaine. Ropivacaine is commonly supplied for pharmaceutical use in the form of ropivacaine hydrochloride monohydrate, which is the pharmacopoeial form covered by USP and other major pharmaceutical standards. USP identifies ropivacaine hydrochloride monohydrate with the molecular formula C₁₇H₂₆N₂O·HCl·H₂O, molecular weight 328.88 g/mol, and CAS Number 132112-35-7.
Ropivacaine works by reversibly inhibiting voltage-gated sodium channels, reducing the initiation and propagation of nerve impulses. Its pharmacological profile makes it an important active pharmaceutical ingredient for regional anesthesia products. Ropivacaine hydrochloride is used in pharmaceutical preparations intended for procedures such as epidural anesthesia, peripheral nerve blocks, infiltration anesthesia and other regional anesthetic applications.
For API manufacturing and pharmaceutical development, correct control of chemical identity, stereochemical purity, assay, water content and related substances is particularly important. Ropivacaine is a chiral molecule, and therefore control of the undesired R-enantiomer is an important part of quality evaluation.
Ropivacaine free base has the molecular formula C₁₇H₂₆N₂O, molecular weight 274.40 g/mol, and CAS Number 84057-95-4.
The pharmaceutical hydrochloride monohydrate form has the molecular formula C₁₇H₂₆N₂O·HCl·H₂O and molecular weight 328.88 g/mol. Its primary CAS Number is 132112-35-7. The corresponding anhydrous hydrochloride form is identified by CAS Number 98717-15-8.
Ropivacaine hydrochloride monohydrate is described as a white or almost white crystalline powder. Pharmacopoeial information describes it as soluble in water and ethanol and slightly soluble in methylene chloride.
Ropivacaine hydrochloride API is used in the manufacture and development of pharmaceutical preparations for local and regional anesthesia. It is particularly relevant to injectable formulations where controlled purity, appropriate water content, low levels of related substances and suitable microbiological quality are essential.
Ropivacaine hydrochloride injection is a sterile solution of ropivacaine hydrochloride in Water for Injection. The USP injection monograph specifies an acceptance range of 90.0% to 110.0% of the labeled amount of ropivacaine hydrochloride.
Quality control of Ropivacaine API includes identification by infrared spectroscopy and chloride identification, assay, related-substance testing, enantiomeric purity, pH and water determination. The current USP monograph specifies 98.5%–101.0% assay on the anhydrous basis. USP also specifies water content of 5.0%–6.0% for the monohydrate form.
USP limits bupivacaine to NMT 0.2%, any other individual impurity to less than 0.1%, and total impurities to NMT 0.5%. Enantiomeric purity is also controlled, with the Ropivacaine Related Compound B limit specified at NMT 0.5%.
Swapproop focuses on pharmaceutical API manufacturing and documentation requirements for customers involved in pharmaceutical formulation, development and commercial production. Ropivacaine API can be supplied with appropriate quality documentation and analytical support according to the applicable product specification.
Ropivacaine hydrochloride should be protected from moisture and maintained in well-closed containers. USP specifies preservation in well-closed containers and controlled storage conditions.
Typical pharmaceutical documentation can include a Certificate of Analysis (CoA), specification sheet, Safety Data Sheet (SDS/MSDS), Certificate of Origin and other quality or regulatory documents as applicable to the order and destination market.
Ropivacaine is an established local anesthetic API with defined pharmacopoeial quality requirements and applications in regional anesthesia. Careful control of identity, assay, water content, related substances and stereochemical purity supports consistent API quality for pharmaceutical manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5% – 101.0% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 4.5 – 6.0 |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 0.5% |
| Water Content | 5.0% – 6.0% |