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Hydroxychloroquine Sulfate API is a well-established antimalarial and disease-modifying antirheumatic drug (DMARD) widely used for the treatment and prevention of malaria, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune conditions. It is a 4-aminoquinoline derivative, chemically related to chloroquine, but offers improved safety and tolerability.
At Bluepill Express, Hydroxychloroquine Sulfate API is manufactured with strict adherence to WHO-GMP, ISO 9001:2015, and cGMP guidelines, ensuring the highest standards of purity, potency, and consistency. Our API complies with USP / BP / IP pharmacopoeial standards, making it suitable for global pharmaceutical formulations.
Hydroxychloroquine Sulfate acts by inhibiting heme polymerase activity in the malaria parasite, leading to toxic accumulation of heme and parasite death. Its immunomodulatory properties also make it effective in controlling inflammation, immune cell activation, and cytokine release in autoimmune disorders. The API is supplied in fine crystalline powder form, ideal for tablet and capsule formulation.
Therapeutic Applications:
- Treatment and prophylaxis of malaria (Plasmodium vivax, P. ovale, P. malariae, P. falciparum)
- Management of rheumatoid arthritis
- Used in therapy for systemic lupus erythematosus (SLE)
- Beneficial in discoid lupus erythematosus and autoimmune skin disorders
- Investigated for immunomodulatory roles in viral infections and inflammation-related diseases
Technical Specifications:
- Chemical Name: Hydroxychloroquine Sulfate
- Molecular Formula: C₁₈H₂₆ClN₃O·H₂SO₄
- Molecular Weight: 433.95 g/mol
- CAS Number: 747-36-4
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0%
- Solubility: Freely soluble in water; sparingly soluble in alcohol
- Melting Point: 240°C (decomposes)
- Storage: Store below 30°C, in airtight containers, protected from light and moisture
Pharmacological Action:
Hydroxychloroquine Sulfate functions as a lysosomotropic agent—it increases the pH of intracellular vacuoles, thereby interfering with parasite growth and immune cell signaling. It also inhibits antigen presentation and cytokine release, contributing to its anti-inflammatory and immunosuppressive effects.
In malaria, it acts on the erythrocytic stage of the Plasmodium parasite, while in autoimmune diseases, it modulates immune activity by reducing TLR signaling and autoantibody production. This dual mechanism makes it one of the most versatile APIs in modern medicine.
Manufacturing & Quality Assurance (by Bluepill Express):
- Manufactured under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities
- Conforms to USP / BP / IP pharmacopoeial standards
- Every batch validated for assay, related substances, moisture, and pH
- Supported by COA, MSDS, and DMF documentation for regulatory compliance
- Exported to regulated and semi-regulated markets worldwide
- Stringent HPLC and UV spectrophotometric testing ensures batch-to-batch uniformity
Advantages of Bluepill Express Hydroxychloroquine Sulfate API:
- High purity and stability for tablet manufacturing
- Excellent solubility and flow properties for direct compression
- Long shelf life under recommended conditions
- Global standard quality with complete regulatory support
- Available in bulk packaging for large-scale export orders
