Swapnroop Drugs & Pharmaceuticals offers Bupivacaine Hydrochloride API for pharmaceutical manufacturing, formulation development and local anaesthetic applications.
Bupivacaine Hydrochloride is a long-acting amide-type local anaesthetic. It produces reversible inhibition of nerve impulse conduction by blocking voltage-gated sodium channels in neuronal membranes.
Bupivacaine Hydrochloride is chemically identified as (2RS)-1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride monohydrate.
The pharmacopoeial monohydrate has the molecular formula C18H29ClN2O2 and a relative molecular mass of approximately 342.9 g/mol. The anhydrous hydrochloride has CAS 18010-40-7 and molecular weight 324.9 g/mol, while the monohydrate is CAS 73360-54-0. USP identifies Bupivacaine Hydrochloride as the monohydrate form. (usp.org)
Product Name: Bupivacaine Hydrochloride
Salt Form: Bupivacaine Hydrochloride Monohydrate
CAS Number: 73360-54-0
Anhydrous CAS Number: 18010-40-7
Molecular Formula: C18H29ClN2O2
Molecular Weight: 342.90 g/mol
Anhydrous Molecular Weight: 324.90 g/mol
Chemical Class: Amide-type local anaesthetic
Therapeutic Category: Local Anaesthetic
Pharmacological Class: Long-acting amide local anaesthetic
Bupivacaine Hydrochloride is used as a local anaesthetic for regional and local anaesthesia. Pharmaceutical preparations include injections used for infiltration, peripheral nerve block, epidural and other regional anaesthetic techniques.
Bupivacaine Hydrochloride is a white or almost white crystalline powder or colourless crystals. It is soluble in water and freely soluble in ethanol (96%). The BP/Ph. Eur. monograph specifies protection from light. (nhathuocngocanh.com)
Appearance: White or almost white crystalline powder or colourless crystals
Identification: IR / TLC / chloride reaction / optical rotation
Assay: 98.5%–101.0% on dried substance according to BP/Ph. Eur.
USP Assay: 98.5%–101.5% on anhydrous basis
Loss on Drying: 4.5%–6.0%
Sulfated Ash: NMT 0.1%
Heavy Metals: NMT 10 ppm
pH / Acidity-Alkalinity: Approximately 4.7
Optical Rotation: -0.10° to +0.10°
Individual Impurity B: NMT 0.5%
Individual Impurity F: NMT 0.02%
Any Other Individual Impurity: NMT 0.2%
Total Secondary Impurities Excluding F: NMT 1.0%
Water Content: 4.5%–6.0%
Specific Rotation: -0.10° to +0.10°
Melting Point: Approximately 247–251 °C with decomposition
Solubility: Soluble in water; freely soluble in ethanol (96%)
The BP/Ph. Eur. monograph identifies impurities B and F as specified impurities. Impurity B is limited to 0.5%, impurity F to 0.02%, any other individual secondary impurity to 0.2%, and the sum of secondary impurities excluding impurity F to 1.0%. (nhathuocngocanh.com)
Bupivacaine Hydrochloride API can be supplied in suitable pharmaceutical-grade packaging according to customer requirements, quantity and applicable pharmaceutical handling requirements.
Documentation may include Certificate of Analysis, product specification, safety documentation, analytical data and other quality documents according to product grade and customer requirements.
Store Bupivacaine Hydrochloride protected from light in tightly closed pharmaceutical-grade containers. (nhathuocngocanh.com)
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical customers with Bupivacaine Hydrochloride API sourcing and commercial supply requirements.
Contact Swapnroop Drugs & Pharmaceuticals for Bupivacaine Hydrochloride availability, specifications, documentation, packaging and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR / TLC / Chloride reaction |
| Assay (HPLC) | 98.5% – 101.0% |
| Loss on Drying | 4.5% – 6.0% |
| Residue on Ignition | NMT 0.1% sulfated ash |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | Approximately 4.7 |