Doxofylline active pharmaceutical ingredient supplier

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Product Details:

Storage Room Temperature
Structural Formula [Structural formula available upon request]
Melting Point 211-214C
Shelf Life 36 months
Ingredients Doxofylline
Taste Bitter
Usage Active ingredient in pharmaceutical formulations for respiratory disorders
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Doxofylline active pharmaceutical ingredient supplier Price And Quantity

Minimum Order Quantity 25 Kilograms

Doxofylline active pharmaceutical ingredient supplier Product Specifications

HS Code 2939 5090
Grade Pharmaceutical Grade
Application Used in the treatment of asthma and COPD
Ph Level Neutral (approx. 7, 1% soln)
Molecular Weight 266.26 g/mol
EINECS No 449-200-5
Poisonous Non-poisonous
Physical Form Powder
Purity 99%
Smell Odorless
Molecular Formula C11H14N4O4
Product Type Active Pharmaceutical Ingredient
Shape Crystalline
Density 1.5 Gram per cubic centimeter(g/cm3)
Properties Non-hygroscopic, stable under recommended storage conditions
Taste Bitter
Solubility Freely soluble in water, slightly soluble in ethanol
Usage Active ingredient in pharmaceutical formulations for respiratory disorders
CAS No 69975-86-6
Appearance White to off-white powder
Melting Point 211-214C
Shelf Life 36 months
Ingredients Doxofylline
Structural Formula [Structural formula available upon request]
Storage Room Temperature

Loss on Drying Not more than 0.5%
Residue on Ignition Not more than 0.1%
Chloride Content Not more than 0.05%
Microbial Limit Complies with pharmacopoeial standards
Packaging Double LDPE bags in HDPE drum (25 kg and 50 kg)
Assay (by HPLC) >99%
Total Impurities <0.5%
Single Impurity <0.1%
Heavy Metals Not more than 20 ppm

Doxofylline active pharmaceutical ingredient supplier 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

Doxofylline is a derivative used for the treatment and maintenance of chronic obstructive pulmonary disease (COPD) bronchial asthma and airway spasms. It functions as a bronchodilator by relaxing the smooth muscles of the airways and reducing airway inflammation often referred to as novofylline. Compared to theophylline it provides similar efficacy with significantly fewer cardiovascular and central nervous system side effects.

A Reliable Solution for Respiratory Medications

Doxofylline is utilized as an active ingredient in effective pharmaceutical treatments targeting asthma and chronic obstructive pulmonary disease (COPD). With its optimal purity (>99% by HPLC) and stability, it ensures consistent performance and reliable results in patient therapies.

Product Stability and Storage Recommendations

This API is non-hygroscopic and stable at room temperature, guaranteeing quality retention during transport and storage. The product's recommended packaging-double LDPE bags within HDPE drums-offers enhanced protection against contamination, maintaining its pharmaceutical-grade integrity throughout its shelf life.

Focused on Compliance and Quality

Our Doxofylline meets stringent quality criteria: Loss on Drying 0.5%, heavy metals 20 ppm, chlorides 0.05%, and complies fully with pharmacopoeia-mandated microbial limits. With single and total impurities controlled at <0.1% and <0.5% respectively, it is produced to meet the most demanding industry and regulatory standards.

FAQ's of Doxofylline active pharmaceutical ingredient supplier:

Q: How is Doxofylline used in pharmaceutical applications?

A: Doxofylline serves as an active ingredient in formulations for respiratory disorders such as asthma and COPD. Its high solubility in water and stable crystalline form make it ideal for use in tablets, syrups, and other oral dosage forms.

Q: What quality standards does your Doxofylline comply with?

A: Our Doxofylline conforms to pharmaceutical-grade standards, including: loss on drying (0.5%), heavy metals (20 ppm), chloride content (0.05%), residue on ignition (0.1%), and microbial limits in line with pharmacopoeial requirements. The API displays an assay value exceeding 99% and very low impurity profiles.

Q: When and how should Doxofylline be stored for optimal stability?

A: Doxofylline should be stored at room temperature in a dry environment. Its non-hygroscopic properties and protective packaging (double LDPE bags within an HDPE drum) help maintain stability throughout its 36-month shelf life.

Q: Where do you supply or export Doxofylline from?

A: We are a leading supplier, manufacturer, and exporter of Doxofylline based in India. We provide this API both domestically and internationally through a robust distribution network.

Q: What is the recommended process for ensuring product quality during delivery?

A: Each batch of Doxofylline is packed in double LDPE bags placed inside HDPE drums (25 kg or 50 kg), ensuring product integrity during transit. Strict adherence to good manufacturing practices and quality control checks are in place for each shipment.

Q: What are the benefits of using your Doxofylline in pharmaceutical formulations?

A: Our Doxofylline guarantees high purity, low impurity profile, and remarkable stability, which contribute to improved formulation consistency and efficacy in the management of respiratory disorders.

Q: Is there specific documentation or data available upon request for regulatory or formulation purposes?

A: Yes, we can provide detailed technical data sheets, Certificates of Analysis, and the structural formula upon request to support your regulatory submissions and formulation development.

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