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OFLOXACIN IP
OFLOXACIN IP

OFLOXACIN IP

Price 1800 INR/ Kilograms

MOQ : 25 Kilograms

OFLOXACIN IP Specification

  • Melting Point
  • 270-273C
  • Moisture (%)
  • 1.0%
  • Molecular Formula
  • C18H20FN3O4
  • Heavy Metal (%)
  • 20 ppm
  • Storage
  • Store in tightly closed container, cool and dry place
  • Residue on Ignition
  • 0.1%
  • HS Code
  • 29419060
  • Loss on Drying
  • 0.5%
  • Particle Size
  • D90 < 10 microns
  • Molecular Weight
  • 361.37 g/mol
  • Place of Origin
  • India
  • Assay
  • >= 99.0%
  • Boiling point
  • Not applicable / decomposes
  • Other Names
  • DL-Ofloxacin, Ofloxacinum
  • CAS No
  • 82419-36-1
  • Type
  • Active Pharmaceutical Ingredient (API)
  • Grade
  • Pharmaceutical Grade
  • Usage
  • Pharmaceuticals, Antibacterial agent
  • Purity
  • >= 99%
  • Appearance
  • Crystalline powder
  • Application
  • Used in formulation of oral and parenteral antibacterial drugs
  • Raw Material
  • Fluoroquinolone derivative
  • Smell
  • Odorless
  • Color
  • White to pale yellow
  • Form
  • Powder
  • Related Substances
  • Total impurities 0.5%
  • Solubility
  • Slightly soluble in water, freely soluble in glacial acetic acid, sparingly soluble in ethanol (96%)
  • USP/EP
  • Complies with USP and EP specifications
  • Hazard Class
  • Not classified as hazardous for transport
  • Endotoxin Level
  • <0.25 EU/mg
  • Specific Rotation
  • +180 to +190
  • Packing
  • Packed in fiber drums with double polyethylene bags of 25 kg net each
  • Shelf Life
  • 5 Years
  • Identification
  • Positive by IR and HPLC
 
 

About OFLOXACIN IP

Ofloxacin, as per the Indian Pharmacopoeia (IP), is a broad-spectrum fluoroquinolone antibiotic known for its efficacy against a wide range of bacterial infections. It acts by inhibiting bacterial DNA gyrase, thereby disrupting DNA replication and transcription, leading to bacterial cell death.

Quality Compliance and Purity

Ofloxacin IP is manufactured to meet rigorous USP and EP standards, ensuring high assay values (99.0%) and exceptionally low impurities (0.5%). This consistent quality makes it a reliable choice for pharmaceutical manufacturers seeking superior antibacterial agents.


Product Handling and Storage Recommendations

This API should be stored in tightly closed containers, kept in cool and dry conditions to preserve its stability and five-year shelf life. Its non-hazardous transport classification enhances its practicality for global pharmaceutical supply chains.


Applications in Antibacterial Formulations

As a potent fluoroquinolone antibacterial ingredient, Ofloxacin IP is utilized in the production of both oral and injectable drugs targeting a variety of bacterial infections. Its excellent solubility profile and fine particle size ensure broad versatility in formulation development.

FAQs of OFLOXACIN IP:


Q: How should Ofloxacin IP be stored for maximum shelf life?

A: Ofloxacin IP should be stored in a tightly closed container, in a cool and dry place, to ensure its stability and maintain its five-year shelf life. This helps to prevent moisture absorption and degradation.

Q: What are the key benefits of using Ofloxacin IP in pharmaceutical formulations?

A: Ofloxacin IP offers high purity (99%), compliance with USP and EP standards, and reliable antibacterial activity, making it ideal for use in oral and parenteral medications. Its excellent quality and minimal impurity profile enhance safety and efficacy in drug production.

Q: Where is Ofloxacin IP manufactured and what is its origin?

A: This API is produced in India, known for its robust pharmaceutical manufacturing sector. It is supplied by reputable manufacturers, suppliers, and traders specializing in antibacterial agents.

Q: What is the process for identifying Ofloxacin IP during quality control?

A: Ofloxacin IP is positively identified using Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC) methods during quality assurance, ensuring its authenticity and compliance with standard specifications.

Q: How is Ofloxacin IP packaged for transport and storage?

A: Ofloxacin IP is packed in fiber drums, each lined with double polyethylene bags containing 25 kg net. This packaging ensures product integrity, safety during transit, and protection from moisture and contaminants.

Q: What is Ofloxacin IP primarily used for in the pharmaceutical industry?

A: It serves as an active ingredient in the production of antibacterial drugs, formulated for both oral and injectable use, targeting a wide range of bacterial infections.

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