|Place of Origin:||China|
|Model Number:||Miconazole nitrate|
|Minimum Order Quantity:||1KG|
|Packaging Details:||Aluminum foil bag|
|Payment Terms:||L/C, D/A, D/P, T/T, Western Union, MoneyGram，Alibaba Assurance Order|
|EINECS:||245-256-6||Appearance:||White To Off-white Crysatlline Powder|
API Active Pharmaceutical Ingredient,
Human API Pharma Ingredients
Antifungals pharmaceutical API 99% Miconazole nitrate powder CAS 22832-87-7
The Introductction of Miconazole nitrate
Miconazole is a highly effective, safe and broad-spectrum antifungal agent, which has almost all effects on pathogenic fungi. Its mechanism is to inhibit the sterol synthesis of fungal cell membrane, affect the permeability of cell membrane, inhibit fungal growth, and cause death. The concentration below 4 µ g/mL can inhibit most of the clinically isolated fungi, among which Cryptococcus neoformans, Candida and Coarse spore bacteria are sensitive to this product, while Dermatitis and Histoplasma bacteria are highly sensitive to this product, but Aspergillus is poor. In addition, miconazole also has antibacterial effect on Staphylococcus aureus, Streptococcus, Gram positive cocci and anthrax. It is used for skin fungal infection, such as tinea of hands, feet, body and thigh.
Miconazole nitrate is a synthetic 1-phenethylimidazole derivative, which belongs to the imidazole class of broad-spectrum antifungal drugs and is a common drug for the treatment of dermatophytosis without hormones and without side effects, and its main active ingredient is miconazole.
The antibacterial spectrum, antibacterial activity and mechanism of action of miconazole nitrate are similar to that of clotrimazole.
Miconazole nitrate can be used as an alternative to amphotericin B when it is ineffective in the treatment of deep fungal infections.
Miconazole nitrate is suitable for the treatment of systemic and disseminated infections caused by fungi such as Cryptococcus neoformans and Pseudomonas albicans. It is poorly absorbed orally and stays mainly in the lesion after topical application, with little absorption into the body. It can penetrate into the inflamed joints, vitreous humor and peritoneum, but the concentration in sputum and saliva is low, and the blood-cerebrospinal fluid barrier is poorly penetrated, so it does not easily cross the blood-brain barrier. The plasma protein binding rate is 90%. Mainly inactivated by hepatic metabolism to inactive metabolites. 14%-22% of metabolites are excreted in urine, of which less than 1% are in the original form of the drug. 50% are excreted in the original form from the feces. Half-life α-phase is about 0.4 hours, half-life β-phase is about 2.1 hours, terminal half-life is 20-24 hours.
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Miconazole nitrate has good antibacterial effect on a variety of deep fungi (such as Candida albicans, Aspergillus, Cryptococcus neoformans, Bacillus, Coccidioides, Yeast mimics), certain epidermal fungi and yeasts. It also has antibacterial effect on Gram-positive cocci (such as Staphylococcus, Streptococcus) and bacilli (such as Bacillus anthracis).
1. Miconazole nitrate is used for serious infections caused by Candida spp. including peritonitis, pneumonia and urinary tract infections.
Miconazole nitrate can also be used for secondary infections caused by gram-positive bacteria.2. Topical administration can be used for chronic widespread cutaneous mucosal candidiasis, Candida vulvovaginitis, ringworm, ringworm of the hands, ringworm of the femur, ringworm of the feet, lichen planus, fungal nail infection caused by dermatophytes, yeasts and many other fungi.3. Intravenous administration can be used for severe cryptococcosis, coccidioidomycosis, paracoccidioidomycosis, etc.
Batch No.: HNB20220808
Manufacture Date: Aug., 08th, 2022 Analysis Date: Aug., 09th, 2022 Expiry date: Aug.., 07th, 2024
Storage: Well sealed in cool and dry place
Shelf life: 24 Months when properly stored.
|Appearance||White either type white crystal powder||Complies|
|Identification||A,B complies with the standard||Complies|
|Residue on ignition||≤ 0.2%||0.08%|
|Organic impurities||Single impurity:≤ 0.25%||0.13%|
|Total other impurities: ≤ 0.5%||0.22%|
|Residual solvent||Acetone ≤ 0.5%||0.03%|
|Ethanol ≤ 0.5%||0.02%|
|Loss on drying||≤ 0.5%||0.3%|
|Heavy metals||≤ 10ppm||Complies|
|Assay(on dried basis)||98.0%~102.0%||99.2%|
|Conclusion||This product complies with USP41 Standard|