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AZITHROMYCIN IP/USP

Name: AZITHROMYCIN IP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

AZITHROMYCIN IP/USP Specification

Moisture (%)
Not more than 5.0%

Melting Point
123-125C

Ph Level
6.0 9.0 (as 10% solution)

HS Code
29419090

Loss on Drying
Not more than 5.0%

EINECS No
617-500-5

Storage
Store below 25C; keep container tightly closed

Molecular Formula
C38H72N2O12

Particle Size
D90 10 micron

Boiling point
Not applicable (decomposes before boiling)

Residue on Ignition
Not more than 0.3%

Molecular Weight
749.0 g/mol

Heavy Metal (%)
Not more than 0.001%

Assay
Not less than 95.0% and not more than 102.0%

Place of Origin
India

Other Names
Azithromycin Dihydrate, Azithromycin Monohydrate

CAS No
83905-01-5

Type
Antibiotic; Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Pharmaceuticals; Treatment of bacterial infections

Purity
98.0%

Appearance
White or almost white crystalline powder

Application
Antibiotic; Bacterial infection treatment

Raw Material
For formulation of antibiotic drugs

Smell
Odorless or almost odorless

Color
White

Form
Powder

Identification
Complies with IR and HPLC tests as per IP/USP

Optical Rotation
+5 to +9 (in methanol)

Endotoxins
Complies as per pharmacopoeial standards

Related Substances
Total impurities not more than 2.0% (by HPLC)

Nitrogen Content
5.2% 5.7%

Microbial Limits
Meets IP/USP standards

Shelf Life
36 months from date of manufacture

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

Packing
Custom-available; usually 1 kg, 5 kg, 10 kg or as per client requirement

About AZITHROMYCIN IP/USP

zithromycin is an antibiotic medication belonging to the class of drugs known as macrolides. It is primarily used to treat a variety of bacterial infections, including respiratory tract infections, skin infections, ear infections, and certain sexually transmitted diseases. Azithromycin works by inhibiting the growth of bacteria, thereby stopping the infection from spreading further within the body.

Superior Antibiotic Efficacy

Azithromycin IP/USP demonstrates exceptional efficacy in fighting a wide range of bacterial infections. Its high purity ( 98.0%) and compliance with stringent pharmacopeial standards ensure reliable performance in antibiotic drug formulations. Both dihydrate and monohydrate forms are available, supporting diverse pharmaceutical applications.

Stringent Quality Control

Every batch of Azithromycin undergoes comprehensive testing including IR and HPLC identification, assays between 95.0% and 102.0%, and confirmation of microbial limits, endotoxins, and related substances. These measures guarantee consistency and safety for pharmaceutical manufacturers and enhance therapeutic outcomes.

Custom Packing and Storage Solutions

Flexible packaging options such as 1 kg, 5 kg, or 10 kg bags are available for Azithromycin IP/USP to suit client needs. The product requires storage below 25C in tightly sealed containers, ensuring maintained efficacy and stability over its 36-month shelf life.

FAQ's of AZITHROMYCIN IP/USP:

Q: How should Azithromycin IP/USP be stored to maintain its quality?

A: Azithromycin IP/USP should be stored below 25C in tightly closed containers. Proper storage conditions maintain the product's efficacy, stability, and extend its shelf life for up to 36 months from the date of manufacture.

Q: What are the main applications and benefits of Azithromycin IP/USP?

A: Azithromycin IP/USP is primarily used as an active pharmaceutical ingredient in the manufacture of antibiotic drugs. Its high purity and proven effectiveness help treat a variety of bacterial infections, offering reliable therapeutic benefits.

Q: How is Azithromycin IP/USP identified and tested for quality compliance?

A: The product is verified through IR and HPLC tests in accordance with IP/USP standards. Additional tests assess purity, microbial limits, endotoxin levels, related substances, and nitrogen content to ensure consistent pharmaceutical-grade quality.

Q: When is the best time to use Azithromycin IP/USP in the drug formulation process?

A: Azithromycin IP/USP should be incorporated during the formulation of antibiotics, ensuring its purity, particle size, and chemical properties complement the final dosage form for optimal efficacy in treating bacterial infections.

Q: Where is Azithromycin IP/USP typically sourced from?

A: Azithromycin IP/USP is manufactured and supplied by pharmaceutical companies in India. It is available for global distribution to manufacturers, suppliers, and traders requiring high-quality raw material for antibiotic drug formulations.

Q: What packaging options are available for Azithromycin IP/USP shipments?

A: The product is usually packed in bags of 1 kg, 5 kg, or 10 kg. Custom packaging can be arranged based on individual client requirements, facilitating safe transport and storage.

Q: What is the process for ensuring Azithromycin IP/USP meets pharmacopoeial standards?

A: Each batch undergoes stringent laboratory testing, including impurity profiling by HPLC, microbial limit checks, and verification of chemical properties such as optical rotation and nitrogen content, ensuring compliance with international pharmacopeial standards.

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