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Azithromycin API

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Azithromycin API Specification

Poisonous
Non-poisonous as API, for manufacturing only

Color
White or almost white

Molecular Weight
749.0 g/mol

Molecular Formula
C38H72N2O12

HS Code
29419090

Melting Point
123-125C

Solubility
Slightly soluble in water, freely soluble in methanol and dichloromethane

Shelf Life
4 years

Ph Level
8.0 10.0 (1% solution)

Boiling point
Not available (decomposes)

Structural Formula
C38H72N2O12 (structure available upon request)

EINECS No
617-500-5

Taste
Bitter

Heavy Metal (%)
0.001%

Storage
Store below 25C, protect from moisture

Particle Size
D90 <10 m

Smell
Odorless

Loss on Drying
5.0%

Medicine Name
Azithromycin

Chemical Name
Azithromycin

CAS No
83905-01-5

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
Antibiotic

Purity(%)
98.0%

Appearance
White to off-white powder

Physical Form
Solid

Specific Rotation
+85 to +95 (c=1, CHCl3)

Manufacturing Process
Synthetic

Endotoxins
<0.5 IU/mg

Identification
Complies as per IP/USP specifications

Packaging
HDPE Drum with double polyethylene bags, 25 kg net weight

Microbial Limit
Total aerobic microbial count 1000 CFU/g, Yeast and mold 100 CFU/g

Related Substances
Individual impurity 1.0%, Total impurities 2.0%

Residue on Ignition
0.2%

Azithromycin API Trade Information

Supply Ability
100 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Azithromycin API

Grade Standard	IP
Purity	99%
Packaging Size	25Kg
Packaging Type	Drum
Grade	Pharma Grade
Minimum Order Quantity	25 Kg

What is azithromycin powder used for?Azithromycin is an antibiotic (macrolide-type). This single-dose form of the medication is usedto treat certain infections, including genital infections. It works by stopping the growth of bacteria. This medication will not work for viral infections (such as common cold, flu).

Superb Quality Compliance

Azithromycin API conforms rigorously to pharmaceutical standards, passing IP/USP identification tests, and maintaining impurity limits (1.0% individual, 2.0% total). The API features extremely low residue on ignition (0.2%) and heavy metals (0.001%) for top-tier safety. With a purity of 98.0%, its physical, chemical, and microbial parameters ensure reliable performance for antibiotic medicine production.

Ideal Physical and Chemical Profile

This API appears as a white to off-white, odorless, and bitter-tasting powder. It features a D90 particle size under 10 m and pH levels between 8.0 and 10.0 (1% solution). The compound, C38H72N2O12, melts at 123125C and is slightly soluble in water but freely dissolves in methanol and dichloromethane. Its excellent stability and precise physical form make it suitable for advanced pharmaceutical formulations.

Safe and Secure Packaging

To maintain quality during transport and storage, Azithromycin API is packed in robust HDPE drums with double polyethylene inner bags, each containing 25 kg of material. This packaging method ensures optimal protection against moisture or contamination, aligning with recommended storage at below 25C for a maximum shelf life of 4 years.

FAQs of Azithromycin API:

Q: How is Azithromycin API used in pharmaceutical manufacturing?

A: Azithromycin API is primarily employed as the main ingredient in manufacturing antibiotic formulations such as tablets, capsules, syrups, and suspensions. It delivers broad-spectrum antibacterial action against various infections but is strictly for industrial manufacturing and not for direct consumption.

Q: What quality standards does Azithromycin API comply with?

A: This API adheres to stringent guidelines outlined in IP and USP monographs. It passes specific identification tests, contains total impurities of 2.0%, individual impurity 1.0%, and stays within limits for residues, heavy metals, and microbial contamination, confirming its suitability for pharmaceutical applications.

Q: Where is Azithromycin API manufactured and how is it packaged?

A: Azithromycin API is produced in India through a synthetic process and exported globally. It is securely packed in HDPE drums with double polyethylene bags, ensuring a net weight of 25 kg per drum to maintain product stability during storage and transit.

Q: What are the recommended storage conditions for Azithromycin API?

A: The product should be stored below 25C in a dry, moisture-free environment and kept in its original packaging. Proper storage maintains its integrity and assures a shelf life of up to 4 years.

Q: When should Azithromycin API be used and by whom?

A: The API should be used exclusively by pharmaceutical manufacturers for producing antibiotic medicines. It is not intended for direct consumption and must be handled as per GMP guidelines by trained personnel in licensed facilities.

Q: What are the key benefits of using this Azithromycin API?

A: Manufacturers benefit from high purity, minimal impurity levels, robust microbial control, and reliable batch quality, resulting in effective and consistent antibiotic drugs that meet international regulatory standards.

Q: How is the quality and safety of Azithromycin API ensured during production?

A: The API undergoes rigorous analytic testing throughout synthesis, meeting strict limits for related substances, residue, heavy metals, and microbial counts. Comprehensive documentation and compliance with IP/USP specifications further ensure its safety and efficacy.

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