Quinine Sulfate

Quinine sulfate dihydrate is a defined sulfate salt of quinine, a quinoline alkaloid associated with the bark of Cinchona species. It is chemically distinct from Cinchona bark powder, mixed botanical extracts, quinine hydrochloride, and quinine free base. The crystalline ingredient is used in pharmaceutical, flavor, analytical, and research applications requiring a defined quinine salt.

The dihydrate has a 2:1 quinine-to-sulfate stoichiometry and a molecular weight of 782.94 g/mol. USP defines Quinine Sulfate as containing 99.0–101.0% total alkaloid salt calculated on the anhydrous basis. Commercial sourcing should distinguish pharmacopoeial bulk material, laboratory reagent grades, and official reference standards because they serve different manufacturing and analytical purposes.

Ingredient Profile & Common Uses

Derived from the quinine alkaloid historically associated with Cinchona bark, this ingredient is commercially handled as a defined chemical salt rather than a multi-component botanical extract. The commonly referenced dihydrate is represented by C40H54N4O10S and provides a specific chemical identity based on salt composition and hydration state.

Commercial grade selection is determined by intended use and qualification pathway. Pharmacopoeial material is evaluated against the applicable monograph, whereas laboratory grades may be sold against chemical-purity specifications such as 99%+. Official pharmacopoeial reference standards form a separate analytical category and are not interchangeable with bulk production material. Procurement specifications should therefore identify the required grade type and pharmacopoeial framework where applicable.

The material has a persistent, intense bitter taste, limited aqueous solubility at ambient conditions, and sensitivity to prolonged light exposure. These characteristics are relevant to dissolution sequence, premixing, low-level flavor incorporation, analytical sample preparation, and packaging selection.

Application Areas

Pharmaceutical Manufacturing

As a defined quinine salt, the dihydrate is used in pharmaceutical manufacturing and development where identity, pharmacopoeial compliance, assay basis, impurity control, and qualified raw-material documentation are important.

Carbonated Beverage Flavor Systems

Its intense bitterness supports quinine-containing carbonated beverages. Under U.S. 21 CFR §172.575, quinine supplied as the sulfate or hydrochloride salt is permitted at up to 83 ppm calculated as quinine.

Analytical & Fluorescence Applications

Characteristic fluorescence behavior supports its use in analytical measurements, method development, identity-related testing, and laboratory studies where controlled concentration and chemical identity are important.

Chemical & Formulation Research

The defined salt form is used to study quinine chemistry, dissolution behavior, light exposure, sensory bitterness, analytical recovery, and interactions within aqueous or solvent-based formulation systems.

Typical Specifications

ParameterTechnical Information
Product NameQuinine Sulfate Dihydrate
Common NameQuinine Sulfate / Quinine Sulphate
Chemical IdentityQuinine sulfate (2:1) salt, dihydrate
Parent AlkaloidQuinine
Botanical AssociationCinchona species bark
Ingredient TypeDefined quinine alkaloid salt
Hydration StateDihydrate
Quinine Stoichiometry2:1
CAS Number6119-70-6
Additional CAS Index207671-44-1
Anhydrous Quinine Sulfate CAS804-63-7
Molecular FormulaC40H54N4O10S
Molecular Weight782.94 g/mol
Anhydrous Molecular Weight746.93 g/mol
Chemical ClassQuinoline / Cinchona alkaloid sulfate
USP Monograph Definition99.0–101.0% total alkaloid salt, calculated on the anhydrous basis
Reference AppearanceWhite crystalline powder
Sensory CharacterOdorless with a persistent, very bitter taste
Water BehaviorSlightly soluble in water
Light BehaviorDarkens on exposure to light

Compound Identity & Pharmacopeial Interpretation

Chemical databases and commercial documentation may identify quinine sulfate dihydrate under both CAS 6119-70-6 and 207671-44-1. USP separately identifies anhydrous quinine sulfate under CAS 804-63-7, making hydration state an important detail when matching specifications, COAs, and regulatory documentation.

Formula representation also varies across technical databases. Some reference materials normalize the salt to one quinine unit with one-half equivalent of sulfuric acid and one water molecule, giving a formula weight near 391.47. The complete 2:1 salt representation used in the USP monograph gives 782.94 g/mol. These are different representations of the same stoichiometric relationship rather than separate dihydrate ingredients.

For USP material, assay is expressed as total alkaloid salt on an anhydrous basis. This basis should not be treated as interchangeable with a generic chromatographic purity value or quinine free-base content.

Technical & Quality Considerations

Raw-material qualification should establish the correct salt identity, hydration state, and differentiation from related Cinchona alkaloids. For pharmacopoeial sourcing, the applicable monograph and assay basis are particularly important. Bulk manufacturing material should also be clearly distinguished from official USP or other pharmacopoeial reference standards intended for analytical calibration and compendial testing.

The crystalline material requires attention to dissolution and handling because of its limited water solubility and strong sensory bitterness. Light exposure can also affect appearance, making protective packaging and controlled handling relevant during storage, solution preparation, and analytical work. Concentrated systems may require a defined dissolution sequence rather than direct dispersion.

Formulation calculations should distinguish quinine sulfate mass from quinine free-base equivalent. As a practical reference, a U.S. quinine sulfate drug label identifies 324 mg of quinine sulfate as equivalent to 269 mg quinine free base. This distinction is important when converting concentrations, interpreting limits expressed as quinine, or comparing different quinine salt forms.

Packaging & Commercial Supply

Essencefield supports product evaluation, formulation trials, commercial orders, and ongoing ingredient supply. Packaging, storage, and shipping arrangements are determined by product characteristics, order quantity, stability requirements, and destination-market needs.

Supply ItemGeneral Information
SampleAvailable upon request for formulation, testing, and supplier evaluation
Order Quantities100 g · 1 kg · 5 kg · 25 kg · 100 kg · 500 kg · Bulk
Sample Lead TimeTypically 5–7 days after sample confirmation
Production Lead TimeTypically 15–30 days after order and specification confirmation
PackagingSuitable protective inner packaging with bags, cartons, drums, or other appropriate outer packaging
StorageStore in tightly sealed, suitable protective packaging in a cool, dry environment. Protect from moisture, heat, and direct sunlight. Specific storage conditions follow the approved product specification.
DocumentationCOA · Product Specification · TDS · SDS · Applicable declarations (as applicable)

Final order quantities, lead times, packaging, documentation, and shipping arrangements are confirmed according to the selected product and commercial requirements.

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