Amodiaquine HCL USP active pharmaceutical

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Amodiaquine HCL USP active pharmaceutical

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MOQ : 100 Kilograms

Amodiaquine HCL USP active pharmaceutical Specification

Storage
Store in a cool, dry and well-ventilated place, protected from light

Smell
Odorless

Poisonous
NO

EINECS No
228-023-6

Molecular Formula
C20H22ClN3O2HCl

Taste
Bitter

Melting Point
>220C (decomposes)

Heavy Metal (%)
0.001%

Color
Yellow

Structural Formula
C20H22ClN3O2HCl

Ph Level
4.5-6.5 (1% aqueous solution)

Loss on Drying
0.5%

Boiling point
Not applicable (decomposes before boiling)

HS Code
2933.49

Shelf Life
5 years when stored properly

Molecular Weight
465.8 g/mol

Solubility
Freely soluble in water, methanol; very slightly soluble in chloroform, ether

Particle Size
Micronized (customizable)

Medicine Name
Amodiaquine Hydrochloride

Chemical Name
4-[(7-chloroquinolin-4-yl)amino]-2-[(diethylamino)methyl]phenol dihydrochloride

CAS No
6398-98-7

Type
Active Pharmaceutical Ingredient (API)

Grade
USP

Usage
Antimalarial

Purity(%)
>99%

Appearance
Yellow crystalline powder

Physical Form
Solid

Residual Solvents
Within ICH limits

Related Substances
Total impurities: <0.5%

Endotoxin Level
<0.25 EU/mg

Stability
Stable under recommended storage conditions

Packing
25 kg fiber drums with double polyethylene liners

Regulatory Compliance
DMF, GMP, FDA guidelines compliant

Identification
IR, UV, HPLC Conforms

Chloride Content
16.5%-18.5%

Microbial Limit
Total aerobic microbial count: <1000 cfu/g

Manufacturing Process
Non-animal origin

Amodiaquine HCL USP active pharmaceutical Trade Information

Minimum Order Quantity
100 Kilograms

Supply Ability
1000 Kilograms Per Month

Delivery Time
7 Days

Amodiaquine HCL USP active pharmaceutical About

Amodiaquine HCL USP, a grandiose active pharmaceutical ingredient, ensures excellent access to cost-effective antimalarial solutions. Exhibiting a pristine yellow crystalline appearance, this API is freely soluble in water and methanol with a purity exceeding 99%. Packaged in 25 kg fiber drums with double polyethylene liners, it guarantees secure purchase and transport. Manufactured from non-animal origins and fully compliant with DMF, GMP, and FDA norms, each batch undergoes comprehensive IR, UV, and HPLC identification. Its outstanding microbial and impurity limits, alongside a 5-year shelf life, provide confidence in reliable, high-grade supply for pharmaceutical manufacturers and distributors globally.

Comprehensive Application and Key User Profiles

Amodiaquine HCL USP is chiefly applied in the formulation of antimalarial medications, benefiting healthcare providers and pharmaceutical professionals. Its premium-grade, micronized form makes it compatible with sophisticated machinery in production lines, ensuring uniformity and purity in every batch. Features like customized particle size, non-animal origin, and strict microbial control guarantee versatility and safety on manufacturing surfaces, meeting the precise demands of generic and branded medicine manufacturers.

Market Outreach, Export Spheres, and Certifications

With a robust exchange network, Amodiaquine HCL USP serves India's main domestic market through a reliable drop-off and transport service framework. The product enjoys extensive export to international pharmaceutical sectors, leveraging major logistical partners for efficient delivery. Its certifications ensure recognition in global markets: it adheres to strict DMF, GMP, and FDA guidelines, bolstering seamless regulatory compliance and competitive standing in both local and overseas pharmaceutical landscapes.

FAQ's of Amodiaquine HCL USP active pharmaceutical:

Q: How is Amodiaquine HCL USP identified and verified for pharmaceutical use?

A: Amodiaquine HCL USP is identified and verified using IR, UV, and HPLC techniques, ensuring it conforms to USP grade specifications and delivers reliable results in pharmaceutical applications.

Q: What are the storage requirements for maintaining the pristine quality of Amodiaquine HCL USP?

A: This API should be stored in a cool, dry, and well-ventilated place, protected from light. When stored correctly, it maintains its stability and effectiveness for up to five years.

Q: When can pharmaceutical manufacturers expect delivery, and what transport services are available?

A: Delivery timelines depend on order confirmation and region. The distributor offers efficient transport services, ensuring secure exchange and drop-off of 25 kg drums to both domestic and international clients.

Q: Where is Amodiaquine HCL USP most commonly used and by whom?

A: Amodiaquine HCL USP is primarily utilized in India and exported globally, mainly by pharmaceutical manufacturers, distributors, and healthcare providers dedicated to producing antimalarial medicines.

Q: What benefits do users gain by purchasing Amodiaquine HCL USP from this supplier?

A: Buyers benefit from a stable, cost-effective, and high-quality API, produced to excellent regulatory standards, ensuring safe, reliable, and pristine product supply for their manufacturing needs.

Q: How does the manufacturing process of Amodiaquine HCL USP address health and safety?

A: The API is produced using a non-animal origin process, adheres to strict microbial and endotoxin limits, and is free from heavy metals, ensuring it meets rigorous health and safety benchmarks.

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