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Specifications of Ciprofloxacin hydrochloride hydrate丨86393-32-0
|
Property |
Specification |
|
Grade |
USP 41 |
|
Description |
Faintly yellowish to light yellow crystals |
|
Assay |
98%-102% |
|
Identification (IR) |
It complies with the reference spectrum |
|
Identification (HPLC) |
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay |
|
Chloride |
It shows a positive reaction |
|
pH (1 in 40) |
3.5-4.5 |
|
Water (by K.F.) |
4.7%-6.7% |
|
Residue on ignition |
0.1% max |
|
Residue of Solvents |
|
|
Ethanol |
Not more than 3000 ppm |
|
3-Methyl-1-Butanol |
Not more than 3000 ppm |
|
Chromatographic purity |
|
|
Ciprofloxacin ethylenediamine analog |
Not more than 0.2% |
|
Fluoroquinolonic acid |
Not more than 0.2% |
|
Any other individual impurity |
Not more than 0.2% |
|
The sum of all impurity peaks |
Not more than 0.5% |
Ciprofloxacin hydrochloride hydrate丨86393-32-0 is the hydrochloride salt form of ciprofloxacin, a broad-spectrum fluoroquinolone antibiotic. Ciprofloxacin is widely used to treat a variety of bacterial infections due to its effectiveness against both Gram-positive and Gram-negative bacteria. The hydrate form indicates that the compound contains water molecules in its crystalline structure, which is common in many pharmaceutical formulations.
Clinical Uses of Ciprofloxacin hydrochloride hydrate丨86393-32-0
Treatment of Infections
Respiratory Infections: Ciprofloxacin is effective in treating upper and lower respiratory tract infections, including pneumonia, bronchitis, and sinusitis, often caused by organisms like Streptococcus pneumoniae or Haemophilus influenzae.
Urinary Tract Infections (UTIs): It is commonly prescribed for urinary tract infections, including cystitis (bladder infection) and pyelonephritis (kidney infection), due to its high tissue penetration and efficacy against Escherichia coli and other uropathogens.
Gastrointestinal Infections: Ciprofloxacin hydrochloride hydrate丨86393-32-0 is used to treat gastroenteritis caused by Salmonella, Shigella, and Campylobacter species, among others.
Bone and Joint Infections: It is used in the treatment of osteomyelitis (bone infections) and septic arthritis, particularly when the infections are caused by Gram-negative bacteria like Pseudomonas aeruginosa.
Skin and Soft Tissue Infections: Ciprofloxacin is also effective against skin infections caused by both aerobic and anaerobic bacteria, especially those resulting from wounds, abscesses, or burns.
Anthrax Exposure:
Ciprofloxacin is a first-line treatment for anthrax, particularly inhalational anthrax, as it has been shown to be effective in preventing or treating infection caused by Bacillus anthracis.
Prophylaxis in Certain Infections:
Meningococcal Meningitis: Ciprofloxacin is used in some cases for prophylaxis to prevent meningococcal meningitis following exposure to the bacteria, Neisseria meningitidis.
Traveler's Diarrhea: It is sometimes used for the prevention and treatment of traveler's diarrhea caused by E. coli or Shigella.
Benefits of Ciprofloxacin hydrochloride hydrate丨86393-32-0
Broad-Spectrum Activity:
Ciprofloxacin is effective against a wide range of bacteria, including Gram-positive and Gram-negative organisms, as well as atypical bacteria like Mycoplasma and Chlamydia. This broad-spectrum activity makes it useful in treating various types of infections.
High Bioavailability:
Ciprofloxacin is well-absorbed when taken orally, with an oral bioavailability of approximately 70-80%. This means that a significant amount of the drug reaches systemic circulation and can effectively treat infections.
Penetration into Tissues:
Ciprofloxacin has excellent tissue penetration, including the ability to reach high concentrations in tissues such as the lungs, urinary tract, bones, and soft tissues. This makes it effective for treating infections in these areas.
Effective Against Multi-Drug Resistant Pathogens:
Ciprofloxacin is often used to treat infections caused by multi-drug resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing organisms.
Alternative for Penicillin-Allergic Patients:
For patients who are allergic to penicillin or cephalosporins, ciprofloxacin is a good alternative for treating bacterial infections, particularly those caused by Gram-negative organisms.
Conclusion
Ciprofloxacin hydrochloride hydrate丨86393-32-0 is a highly effective fluoroquinolone antibiotic with a broad spectrum of activity against a variety of bacterial pathogens. It is commonly used to treat respiratory, urinary, gastrointestinal, and soft tissue infections, as well as in the management of anthrax and multi-drug resistant infections. While it offers many benefits, its use is associated with several side effects, including gastrointestinal discomfort, CNS effects, and the risk of tendonitis. Careful dosing and monitoring are required, particularly in vulnerable populations. Ciprofloxacin remains a critical option in the treatment of bacterial infections, but its use should be guided by sensitivity testing and clinical circumstances.
