Hydroxychloroquine Sulphate IP USP contract manufacturing API

Get a Price/Quote

Product Details:

Molecular Weight 433.95 g/mol
Usage Bulk manufacturing of finished pharmaceutical formulations
Solubility Freely soluble in water, practically insoluble in acetone, alcohol
HS Code 29334990
Molecular Formula C18H26ClN3OH2SO4
EINECS No 212-742-4
Physical Form Powder
Click to view more
Share Your Product:

Request To Call Back Send Inquiry

Hydroxychloroquine Sulphate IP USP contract manufacturing API Price And Quantity

Minimum Order Quantity 25 Kilograms

Hydroxychloroquine Sulphate IP USP contract manufacturing API Product Specifications

Grade IP/USP
Poisonous No (non-poisonous under standard usages)
Shape Crystalline
Properties Odorless, stable under recommended storage
Density 1.7 Gram per cubic centimeter(g/cm3)
Shelf Life 5 years from date of manufacture
Application Pharmaceutical formulations, antimalarial drug, treatment for autoimmune diseases
Storage Store in tightly closed container, protected from light, at room temperature
Smell Odorless
Product Type Active Pharmaceutical Ingredient (API)
Purity 99%
Ph Level 5.5 to 7.5 (1% aqueous solution)
Molecular Formula C18H26ClN3OH2SO4
Molecular Weight 433.95 g/mol
HS Code 29334990
Usage Bulk manufacturing of finished pharmaceutical formulations
Solubility Freely soluble in water, practically insoluble in acetone, alcohol
CAS No 747-36-4
Ingredients Hydroxychloroquine Sulphate
Appearance White or off-white crystalline powder
Structural Formula [Structural formula available on product COA/MSDS]
Melting Point 240C to 244C (decomposition)
Physical Form Powder
EINECS No 212-742-4
Taste Bitter

Manufacturer Certification ISO 9001:2015, WHO-GMP certified facility
Heavy Metals NMT 10 ppm
Regulatory Support DMF/CMC documentation available on request
Stability Data Available for 36 months under ICH conditions
Certificate of Analysis Available with every batch
Microbial Limits Total aerobic microbial count NMT 1000 cfu/g
Residual Solvents Complies with ICH Q3C guidelines
Loss on Drying NMT 0.5%
Identification By IR/UV conforming to standard reference
Manufacturing Process Complies with cGMP guidelines
Compliance IP/USP/Ph. Eur. available
Particle Size D90 less than 150 micron
Therapeutic Category Antimalarial, Antirheumatic
Standard Packing 25 kg HDPE drum with double polyethylene bags

Hydroxychloroquine Sulphate IP USP contract manufacturing API Trade Information

FOB Port ALL india and export
Payment Terms Cash Advance (CA), Cash in Advance (CID)
Supply Ability 1000 Kilograms Per Week
Delivery Time 7 Days
Sample Available Yes
Sample Policy Contact us for information regarding our sample policy
Main Export Market(s) Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
Main Domestic Market All India

Product Description

Hydroxychloroquine sulfate is a prescription medication primarily used to treat autoimmune diseases like systemic lupus erythematosus (SLE) and rheumatoid arthritis, as well as to prevent and treat malaria.

Reliable Antimalarial and Antirheumatic API Solution

Hydroxychloroquine Sulphate IP/USP is trusted by pharmaceutical manufacturers for its consistent quality and broad therapeutic applications. With a commitment to cGMP manufacturing practices and regulatory compliance, this API is suited for pharmaceutical partners seeking a reliable ingredient for antimalarial and autoimmune formulations. Each batch is clearly documented, and extensive regulatory support ensures smooth global market access.

Safety, Quality, and Stability Guaranteed

Manufactured in facilities holding ISO 9001:2015 and WHO-GMP certifications, Hydroxychloroquine Sulphate undergoes strict quality assurance processes. Its high purity, minimal impurity profile, and adherence to ICH stability guidelines deliver confidence in product longevity, safety, and efficacy for pharmaceutical applications. With heavy metals NMT 10 ppm, loss on drying under 0.5%, and a shelf life of five years, every batch provides assured quality.

Comprehensive Regulatory and Technical Support

Every order of Hydroxychloroquine Sulphate API includes a Certificate of Analysis and, upon request, complete regulatory documentation such as DMF/CMC dossiers. This comprehensive support streamlines approvals for finished dosage forms and facilitates international distribution and import activities. Our team assists partners from order placement through post-dispatch assistance, ensuring complete satisfaction.

FAQ's of Hydroxychloroquine Sulphate IP USP contract manufacturing API:

Q: How is Hydroxychloroquine Sulphate IP/USP manufactured for contract API supply?

A: Hydroxychloroquine Sulphate is produced under rigorous cGMP guidelines in ISO 9001:2015 and WHO-GMP-certified facilities. All production batches comply with quality standards (IP, USP, Ph. Eur.), ensuring product consistency and safety for pharmaceutical applications.

Q: What are the main applications of Hydroxychloroquine Sulphate API?

A: This API is primarily used in the bulk manufacturing of pharmaceutical formulations, including antimalarial drugs and treatments for autoimmune diseases such as rheumatoid arthritis and lupus, thanks to its reliable therapeutic profile.

Q: When is the Certificate of Analysis provided for Hydroxychloroquine Sulphate?

A: A detailed Certificate of Analysis (COA) is included with every batch, outlining compliance with relevant quality and purity standards, including identification by IR/UV testing, microbial limits, residual solvents, and stability results.

Q: Where should Hydroxychloroquine Sulphate be stored for optimal stability?

A: For best results, store the API in a tightly closed container, protected from light, at room temperature. This ensures product integrity and preserves its five-year shelf life as supported by ICH stability data.

Q: What is the process for obtaining regulatory documentation like DMF or CMC?

A: Regulatory support, including Drug Master File (DMF) or Common Technical Document (CMC) submissions, is available upon request. This documentation helps clients meet regulatory requirements for global markets and streamlines product approval processes.

Q: How does Hydroxychloroquine Sulphate benefit pharmaceutical manufacturers?

A: With its high purity (99%), extended shelf life, compliance with multiple pharmacopeias, and comprehensive support, this API enables manufacturers to confidently supply safe, effective medicines while simplifying documentation and regulatory pathways.

Q: Can Hydroxychloroquine Sulphate API be supplied internationally?

A: Yes, the product can be supplied globally to distributors, exporters, importers, and manufacturers. All shipments adhere to international quality and safety regulations, ensuring suitability for diverse pharmaceutical markets.

Tell us about your requirement

Price:

Quantity

Select Unit

50
100
200
250
500
1000+

Additional detail

Mobile number

Other Products in 'Chemicals & Intermediates' category

Doxofylline API with COA Minimum Order Quantity : 100 Smell : Other, Odourless Ph Level : Neutral (pH 6.07.5 in 1% solution) Purity : 99% (HPLC) Product Type : API (Active Pharmaceutical Ingredient) Storage : Other, Store in tightly closed container, protected from light and moisture at 28C Application : Other , Pharmaceutical synthesis, respiratory medicines Grade : Pharmaceutical Grade Poisonous : Other, Nonpoisonous Properties : White to off white, odourless, crystalline powder Shape : other, Crystalline Shelf Life : 36 months Physical Form : Powder EINECS No : 2747342 Taste : Other, Practically tasteless CAS No : 69975866 Ingredients : Doxofylline Structural Formula : Included as C11H14N4O4 Melting Point : 230C Appearance : White to offwhite powder Molecular Weight : 266.26 g/mol HS Code : 29420090 Solubility : Freely soluble in water, partly soluble in methanol Usage : Used in treatment of asthma and COPD Molecular Formula : C11H14N4O4 Density : 1.3 Gram per cubic centimeter(g/cm3)

Send Inquiry

Furosemide BP API Minimum Order Quantity : 100 Smell : Other, Odorless Ph Level : 5.5 6.5 (1% solution in water) Purity : 99% min Product Type : Active Pharmaceutical Ingredient Storage : Other, Store in tightly closed container, protected from light, at 1530C Application : Other , Diuretic in pharmaceutical formulations Grade : BP (British Pharmacopoeia) Poisonous : Other, No, if used as directed for pharmaceutical purposes Properties : White to offwhite crystalline powder, odorless, stable under recommended storage conditions Shape : other, Crystalline Shelf Life : 5 years under recommended storage Physical Form : Powder EINECS No : 2002036 Taste : Other, Slightly bitter CAS No : 54319 Ingredients : Furosemide Structural Formula : [see chemical abstracts or available BP monograph] Melting Point : Approx. 210C (with decomposition) Appearance : White to nearly white crystalline powder Molecular Weight : 330.74 g/mol HS Code : 29420090 Solubility : Slightly soluble in water, soluble in dilute alkali hydroxides, soluble in alcohol and acetone Usage : Used to treat fluid retention (edema) and hypertension Molecular Formula : C12H11ClN2O5S Density : 1.7 Gram per cubic centimeter(g/cm3)

Send Inquiry

Guaifenesin IP USP API Minimum Order Quantity : 100 Smell : Other, Odourless to almost odourless Ph Level : 5.0 7.0 (1% solution) Purity : 99% minimum Product Type : Active Pharmaceutical Ingredient (API) Storage : Other, Store in a tightly closed container, in a cool, dry place, protected from light Application : Other , Pharmaceuticals, Expectorant in cough syrups Grade : IP/USP Poisonous : NO Properties : White or almost white crystalline powder; odourless or almost odourless; hygroscopic Shape : other, Crystalline Shelf Life : 5 years from date of manufacture Physical Form : Powder EINECS No : 2022225 Taste : Other, Slightly bitter CAS No : 93141 Ingredients : Guaifenesin Structural Formula : C10H14O4 Melting Point : 7882C Appearance : White crystalline powder Molecular Weight : 198.22 g/mol HS Code : 29329900 Solubility : Freely soluble in water, soluble in alcohol Usage : Formulation of cough suppressants and expectorant medications Molecular Formula : C10H14O4 Density : 1.116 Gram per cubic centimeter(g/cm3)

Send Inquiry

Hydroxychloroquine Sulphate IP USP API with COA Minimum Order Quantity : 100 Smell : Other, Odorless Ph Level : 4.5 6.5 (2% solution) Purity : 99.50% (by HPLC) Product Type : Active Pharmaceutical Ingredient (API) Storage : Other, Store below 30C, protected from light and moisture Application : Other , Pharmaceuticals (API used in antimalarial and autoimmune treatment) Grade : IP/USP Poisonous : NO Properties : White to offwhite crystalline powder, odorless, bitter taste, nonhygroscopic Shape : other, Crystalline Shelf Life : 5 years from date of manufacture Physical Form : Powder EINECS No : 2128172 Taste : Bitter CAS No : 747364 Ingredients : Hydroxychloroquine Sulphate Structural Formula : [Structural Formula for Hydroxychloroquine Sulphate] Melting Point : 240250C (decomposes) Appearance : White or almost white crystalline powder Molecular Weight : 433.95 g/mol HS Code : 29334900 Solubility : Freely soluble in water, slightly soluble in alcohol Usage : Used in treatment of malaria, rheumatoid arthritis, lupus erythematosus Molecular Formula : C18H26ClN3O.H2SO4 Density : 1.36 Gram per cubic centimeter(g/cm3)

Send Inquiry

SEND INQUIRY CALL ME FREE