Hydroxychloroquine Sulphate IP USP contract manufacturing API

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Hydroxychloroquine Sulphate IP USP contract manufacturing API

Name: Hydroxychloroquine Sulphate IP USP contract manufacturing API
Brand: NR LIFE CARE
Price: 1 INR
Availability: InStock

Price 1 INR/ Kilograms

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MOQ : 25 Kilograms

Hydroxychloroquine Sulphate IP USP contract manufacturing API Specification

Grade
IP/USP

Structural Formula
[Structural formula available on product COA/MSDS]

Purity
99%

Product Type
Active Pharmaceutical Ingredient (API)

HS Code
29334990

Solubility
Freely soluble in water, practically insoluble in acetone, alcohol

CAS No
747-36-4

Ph Level
5.5 to 7.5 (1% aqueous solution)

Appearance
White or off-white crystalline powder

Molecular Weight
433.95 g/mol

Molecular Formula
C18H26ClN3OH2SO4

Melting Point
240C to 244C (decomposition)

Application
Pharmaceutical formulations, antimalarial drug, treatment for autoimmune diseases

Density
1.7 Gram per cubic centimeter(g/cm3)

Storage
Store in tightly closed container, protected from light, at room temperature

Shelf Life
5 years from date of manufacture

Properties
Odorless, stable under recommended storage

Ingredients
Hydroxychloroquine Sulphate

Smell
Odorless

Taste
Bitter

Physical Form
Powder

Usage
Bulk manufacturing of finished pharmaceutical formulations

EINECS No
212-742-4

Shape
Crystalline

Identification
By IR/UV conforming to standard reference

Heavy Metals
NMT 10 ppm

Manufacturing Process
Complies with cGMP guidelines

Standard Packing
25 kg HDPE drum with double polyethylene bags

Regulatory Support
DMF/CMC documentation available on request

Certificate of Analysis
Available with every batch

Microbial Limits
Total aerobic microbial count NMT 1000 cfu/g

Loss on Drying
NMT 0.5%

Therapeutic Category
Antimalarial, Antirheumatic

Stability Data
Available for 36 months under ICH conditions

Residual Solvents
Complies with ICH Q3C guidelines

Particle Size
D90 less than 150 micron

Compliance
IP/USP/Ph. Eur. available

Manufacturer Certification
ISO 9001:2015, WHO-GMP certified facility

Hydroxychloroquine Sulphate IP USP contract manufacturing API Trade Information

Minimum Order Quantity
25 Kilograms

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

About Hydroxychloroquine Sulphate IP USP contract manufacturing API

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.

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