Product Description
Quinidine Sulphate is a vital pharmaceutical ingredient used in the treatment of various cardiac arrhythmias and malaria. As a stereoisomer of quinine, it plays a crucial role in managing irregular heart rhythms by stabilizing cardiac electrical activity. Additionally, it has been historically used in malaria treatment due to its antimalarial properties.
At Prism Industries Pvt. Ltd., we are dedicated to manufacturing premium-quality Quinidine Sulphate, ensuring high purity, stability, and compliance with international pharmaceutical standards.
Identification
Quinidine Sulphate is an alkaloid derived from the bark of the Cinchona tree. It is known for its ability to modulate heart rhythms and act as an antimalarial agent. This API pharmaceutical company ingredient has been widely utilized in modern medicine for treating atrial and ventricular arrhythmias.
Chemical Properties:
Chemical Name: Quinidine Sulphate
Molecular Formula: C20H24N2O2·H2SO4
Molecular Weight: 422.5 g/mol
CAS Number: 50-54-4
Appearance: White to off-white crystalline powder
Regulatory Documents & Compliance
Ensuring compliance with global regulatory frameworks, Prism Industries Pvt. Ltd. provides necessary documentation to support the safe and legal use of Quinidine Sulphate in pharmaceutical formulations.
Regulatory Standards & Certifications:
Good Manufacturing Practices (GMP) Certified
U.S. Pharmacopeia (USP) Compliant
European Pharmacopoeia (EP) Standarer
Drug Master File (DMF) Available
REACH Compliant
Our regulatory team ensures that all API manufacturing industry processes meet stringent global safety, purity, and efficacy guidelines.
Specifications
We provide Quinidine Sulphate with specifications that align with pharmaceutical industry requirements.
Key Specifications:
Purity: ≥ 98%
Melting Point: 250-255°C
Loss on Drying: ≤ 0.5%
Sulfated Ash: ≤ 0.1%
Heavy Metals: ≤ 10 ppm
Optical Rotation: -160° to -180°
Our API pharmaceutical company ensures that each batch of Quinidine Sulphate is thoroughly tested to meet these specifications.
Solubility
Quinidine Sulphate exhibits solubility characteristics that make it suitable for pharmaceutical formulations.
Soluble in: Water, dilute acids
Partially soluble in: Alcohol
Insoluble in: Ether, chloroform
This solubility profile enhances its bioavailability when used in oral and injectable medications.
Assay
Each batch of Quinidine Sulphate undergoes rigorous testing to determine its potency and purity.
Assay by Titration: ≥ 98%
Assay by HPLC: 98-102%
These assay methods ensure that our pharmaceutical ingredient meets the highest industry standards for effectiveness and safety.
Chromatographic Purity by HPLC
High-Performance Liquid Chromatography (HPLC) is used to assess the chromatographic purity of Quinidine Sulphate.
HPLC Parameters:
Mobile Phase: Acetonitrile: Water (60:40)
Column: C18, 250 mm × 4.6 mm
Detection Wavelength: 254 nm
Retention Time: 10-12 minutes
Impurity Limits: ≤ 0.5%
Our stringent chromatographic purity analysis ensures the lowest possible impurities, making Quinidine Sulphate safe for pharmaceutical use.
Why Choose Prism Industries Pvt. Ltd. for Quinidine Sulphate?
As a trusted API pharmaceutical company, Prism Industries Pvt. Ltd. excels in producing high-quality Quinidine Sulphate that meets global healthcare demands.
Our Advantages:
High Purity & Quality:
We ensure pharmaceutical-grade Quinidine Sulphate with a purity of ≥ 98%, complying with USP and EP standards.
Advanced Manufacturing Facilities:
Our API manufacturing industry facilities use state-of-the-art equipment for precision and consistency.
Regulatory Compliance:
We provide comprehensive documentation, including COA, MSDS, and DMF support, ensuring ease of regulatory approval.
Sustainable & Ethical Sourcing:
We adhere to ethical raw material sourcing and environmentally friendly manufacturing processes.
Custom Formulations & Bulk Supply:
Our flexible production capabilities allow us to cater to customized pharmaceutical requirements in bulk quantities.
Global Distribution Network:
As a recognized API pharmaceutical company, we ensure timely delivery to global markets.
Quinidine Sulphate remains an essential pharmaceutical ingredient for treating cardiac arrhythmias and malaria. At Prism Industries Pvt. Ltd., we are dedicated to delivering premium-quality API manufacturing industry solutions with the highest purity and regulatory compliance. Our commitment to innovation, safety, and customer satisfaction ensures that we continue to be a reliable partner for pharmaceutical companies worldwide.
FAQs:
Quinidine Sulphate is a pharmaceutical active ingredient and a Cinchona-derived alkaloid. It is a stereoisomer of quinine and is primarily associated with pharmaceutical formulations used in the management of certain cardiac arrhythmias.
Prism Industries Pvt. Ltd. is a Quinidine Sulphate manufacturer in India, supplying pharmaceutical-grade Quinidine Sulphate API to pharmaceutical companies and B2B customers for domestic and international requirements.
Quinidine Sulphate is primarily used as a pharmaceutical ingredient in medicines intended for the management of certain irregular heart rhythms. It has also historically been associated with antimalarial applications.
Quinidine is a naturally occurring alkaloid associated with the bark of the Cinchona tree. Cinchona bark contains several important alkaloids that have long been used in pharmaceutical applications.
The molecular formula currently listed for Quinidine Sulphate by Prism Industries is C20H24N2O2·H2SO4, with a listed molecular weight of approximately 422.5 g/mol.
Prism Industries’ product page currently lists CAS Number 50-54-4 for Quinidine Sulphate. Buyers should verify the exact chemical form, hydration state, CAS number, and specification against the latest COA and regulatory documentation before ordering.
Quinidine Sulphate is described as a white to off-white crystalline powder. Its physical and chemical characteristics are tested as part of quality control procedures.
Prism Industries lists a purity specification of ≥98% for Quinidine Sulphate. Batch-specific purity and analytical results should be confirmed using the Certificate of Analysis supplied with the product.
Prism Industries lists an assay of ≥98% by titration and an HPLC assay range of 98%–102%. Analytical testing is performed to help ensure the consistency and quality of each batch.
Yes. According to the product specifications, Quinidine Sulphate is soluble in water and dilute acids, partially soluble in alcohol, and insoluble in ether and chloroform.
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Our minimum order quantities vary depending on the product:
- Active Pharmaceutical Ingredients (APIs): 1 kg
- Excipients: 5 kg
- Finished Dosage Forms: 1,000 units
- Custom Orders: Determined on a case-by-case basis
We accept the following payment methods:
- Bank Transfers: EUR, USD, GBP
- Credit/Debit Cards: Visa, MasterCard
- PayPal: For international transactions
API Pharmaceutical Manufacturing Company is a dedicated manufacturer of high-quality pharmaceutical ingredients and finished products. We control the entire production process to ensure compliance with the highest standards of quality and safety.
We primarily serve business clients in the pharmaceutical, biotech, and healthcare industries. For individual customers, we recommend reaching out to our authorized distributors.