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Specifications of Cefdinir丨91832-40-5
|
Grade: |
CP2020 |
|
Characteristics: |
Faintly yellow to yellow crystalline powder, slight odour |
|
Assay: |
94.0% min (on anhydrous) |
|
Identification: |
IR, HPLC Complies |
|
Crystalline: |
Complies |
|
Specific Rotation: |
-58° ~ -66° |
|
Specific absorbance: |
570 ~ 610 |
|
pH: |
2.5 ~ 4.5 |
|
Water: |
2.0% max |
|
Residue on ignition: |
0.2% max |
|
Heavy metals: |
10 ppm max |
|
Tetrahydrofuran: |
0.072% max |
|
Methylene chloride: |
0.06% max |
|
Triethylamine: |
0.032% max |
|
Acetic acid: |
0.5% max |
|
Ethanol: |
0.5% max |
|
Impurity A: |
0.5% max |
|
Impurity B: |
0.2% max |
|
Impurity C: |
0.2% max |
|
Impurity D: |
0.2% max |
|
Impurity E: |
0.5% max |
|
Impurity F: |
0.5% max |
|
Impurity O: |
0.2% max |
|
Impurity P: |
0.5% max |
|
Impurity Q: |
0.5% max |
|
Impurity R: |
0.5% max |
|
Impurity S: |
0.5% max |
|
Impurity T: |
0.5% max |
|
Impurity U: |
0.5% max |
|
Impurities G + H: |
0.7% max |
|
Impurities I + J + K + L: |
0.7% max |
|
Impurities M + N: |
0.7% max |
|
Any Individual impurity: |
0.2% max |
|
Total impurities: |
3.0% max |
|
Total Microbial count: |
1000 CFU/g max |
|
Moulds and yeasts: |
100 CFU/g max |
|
Escherichia Coli: |
ND |
Overview
Cefdinir丨91832-40-5 is a broad-spectrum, third-generation cephalosporin used primarily as an oral antibiotic for treating various bacterial infections. It exhibits strong activity against Gram-positive and Gram-negative bacteria, making it a valuable option in outpatient settings.
Applications of Cefdinir丨91832-40-5
1. Treatment of Respiratory Tract Infections
Cefdinir丨91832-40-5 is commonly prescribed for:
● Acute bacterial otitis media (middle ear infection)
● Pharyngitis/tonsillitis (caused by Streptococcus pyogenes)
● Sinusitis
● Acute exacerbations of chronic bronchitis
● Community-acquired pneumonia
It is particularly effective against common respiratory pathogens such as:
● Streptococcus pneumoniae
● Haemophilus influenzae
● Moraxella catarrhalis
2. Skin and Soft Tissue Infections
● Used to treat uncomplicated skin and skin structure infections (SSSIs), such as:
oCellulitis
oImpetigo
oWound infections
● Active against Staphylococcus aureus and Streptococcus pyogenes, which are common causative agents.
3. Pediatric and Geriatric Use
● Frequently used in pediatric populations, especially for ear and throat infections, due to its pleasant taste in suspension form and favorable safety profile.
● Also suitable for elderly patients, as it has good oral bioavailability and can often eliminate the need for injectable antibiotics.
Benefits of Cefdinir丨91832-40-5
1. Broad-Spectrum Activity
● Effective against a wide range of Gram-positive and Gram-negative organisms, including β-lactamase-producing strains.
● Good alternative to penicillin and older cephalosporins when resistance is suspected.
2. Oral Administration
● Available as oral capsules and powder for oral suspension, making it ideal for outpatient use and pediatric care.
● Eliminates the need for intravenous antibiotics in many cases.
3. Good Tolerability and Safety Profile
● Generally well-tolerated, with most adverse effects being mild and self-limited.
● Less likely to cause allergic reactions compared to penicillin.
4. Convenient Dosing
● Typically administered once or twice daily, depending on the indication.
● Short treatment duration (usually 5–10 days) increases patient compliance.
Pharmacokinetics and Mechanism of Action
● Mechanism: Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell lysis and death.
● Absorption: Oral bioavailability ~20-25%; absorption reduced by antacids or iron-containing products.
● Half-life: Approximately 1.7 hours; excreted mostly unchanged in the urine.
● No hepatic metabolism, making it safe for patients with liver impairment (but dose adjustment may be required in renal impairment).
Conclusion
Cefdinir丨91832-40-5 is a well-established third-generation cephalosporin antibiotic that offers broad-spectrum antibacterial coverage, excellent safety, and oral dosing convenience. It's a top choice for treating respiratory, ear, throat, skin, and soft tissue infections, especially in pediatrics and outpatient care. With its high efficacy and tolerability, cefdinir remains a reliable therapeutic option in the age of growing antibiotic resistance, provided it's used judiciously and appropriately.
