Quinine Hydrochloride is the hydrochloride salt of quinine, a naturally occurring cinchona alkaloid with established antimalarial and antiprotozoal activity. For pharmaceutical-grade material, the pharmacopoeial form is commonly specified as Quinine Hydrochloride Dihydrate, containing two molecules of water of crystallization. The current BP/Ph. Eur. specification identifies the dihydrate as C₂₀H₂₄N₂O₂·HCl·2H₂O, molecular weight 396.9 g/mol, CAS 6119-47-7.
Quinine is a cinchona alkaloid used principally as an antimalarial drug. The hydrochloride salt provides a water-soluble pharmaceutical form of the active quinine moiety.
The dihydrate CAS and formula are supported by current BP/Ph. Eur.-referenced specifications.
Form clarification: Quinine hydrochloride without specified hydration can appear in chemical databases under CAS 130-89-2, with molecular weight 360.9 g/mol. The pharmacopoeial pharmaceutical material is the dihydrate, CAS 6119-47-7, MW 396.91 g/mol, and these forms should not be mixed in CMS specifications.
Quinine Hydrochloride belongs to the antimalarial / antiprotozoal class and is a cinchona alkaloid.
Quinine exerts antimalarial activity primarily against the blood stages of susceptible Plasmodium species. It interferes with parasite heme detoxification and contributes to accumulation of toxic heme-related products within the malaria parasite.
The pharmacological activity resides in the quinine moiety; hydrochloride provides the salt form used for pharmaceutical manufacture.
Quinine Hydrochloride API is relevant to:
Quinine and its salts are recognized as antimalarial agents.
Pharmacopoeial descriptions characterize Quinine Hydrochloride Dihydrate as white or almost white or colourless, fine, silky needles, often in clusters. It is soluble in water and freely soluble in 96% ethanol.
Current commercial BP/Ph. Eur.-conforming material reports:
Quinine Hydrochloride Dihydrate can be evaluated using:
The BP/Ph. Eur. monograph includes TLC identification, bromine-water/ammonia reaction, fluorescence, chloride identification and pH testing.
Pharmacopoeial quality control specifically addresses other Cinchona alkaloids, including dihydroquinine hydrochloride and other chromatographically detected impurities.
A current BP/Ph. Eur.-referenced 2026 specification reports:
These limits are specifically associated with the BP 2026 / Ph. Eur. 12th Edition-referenced Quinine Hydrochloride Dihydrate specification and should be checked against the controlled pharmacopoeial edition applicable to your release specification.
Quinine is a stereochemically defined cinchona alkaloid. The chemical structure contains four defined atom stereocenters in the quinine component. PubChem's quinine hydrochloride record specifies the stereochemical configuration through its InChI.
Specific optical rotation is therefore an important quality attribute. A current BP/Ph. Eur.-conforming specification gives:
[α]²⁰D = −258° to −245°, calculated on the dried substance.
Quinine Hydrochloride Dihydrate should be stored in its original packaging and protected from light. A current BP/Ph. Eur.-conforming specification states that no specific temperature requirement is assigned when appropriate original packaging is maintained.
Recommended handling:
Typical pharmaceutical API documentation includes:
Quinine Hydrochloride Dihydrate manufacturing requires controlled salt formation, purification, crystallization, drying and analytical testing.
Particular attention should be given to quinine content, Cinchona alkaloid impurities, optical rotation, moisture/hydration state, sulfated ash and residual solvents.
The finished API should comply with the applicable current BP/Ph. Eur./registered specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0%, dried basis |
| Loss on Drying | 6.0–10.0% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 6.0–6.8 |
| Individual Impurity | NMT 2.0% |
| Total Impurities | NMT 5.0% |