99% Amphotericin B API Powder With GMP
Looking For The Largest Amphotericin B Manufacturers In China? Contact Us Now!
Why You Should Import Amphotericin B Powder From Us?
#1. GMP/DMF Available:
Our powder-manufacturing line is approved by NMPA and our manufacturing is issued with a GMP certificate.
#3. Low MOQ:
Our MOQ for liposomal injection-grade powder starts at 1KG, but the topical type starts from 100G.
We can provide customized packages for your lab research.
#4. Faster Shipping:
If you are taking a standard package, we can ship it out within 2 days and provide you with the tracking by FedEx.
What Is Amphotericin B API Powder?
Cas Number: 1397-89-3
Molecular Formula: C47H73NO17
Molecular Weight: 924.1 g/mol
Chemical Name: (1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(2R,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid
HS Code: 2941909099 (Other antibiotics-其他抗菌素)
Amphotericin B API topical grade or oral grade is a yellow to orange powder used as an antibiotic.
It is a polyene antifungal antibiotic produced by Streptomyces nodosus.
It is insoluble in water but easily soluble in lipids and is one of our competitive pharmaceutical ingredients with China GMP.
Amphotericin can bind to ergosterol to depolarize the membrane and alter cell membrane permeability.
Important intracellular components will leak from cells to cause bacterial cell death.
As a broad-spectrum antifungal antibiotic, it is effective against many fungal species.
Its common side effects include mild to moderate serum aminotransferase elevations and hyperbilirubinemia, but very rare to see acute drug-induced liver injury caused by it.
What Is Amphotericin B Used For?
Amphotericin B is a polyene antifungal antibiotic that inhibits fungal growth by affecting cell membrane permeability.
It has been made into medicines with dosage forms of injections, capsules, etc, but it has other usages.
Below we compiled its main uses, take a look:
#1. Clinical treatment of fungi infections
It is used clinically for the treatment of severe visceral or systemic infections caused by deep-seated fungi.
It is also indicated for the treatment of the following fungal infections:
cryptococcosis, germinosis, disseminated candidiasis, coccidioidomycosis, histoplasmosis, trichinosis caused by Trichinella, Aspergillus, Platyhelminthes, Endocytosis, and Frogminthes, sporotrichosis caused by Schenk’s sporoplasmosis, and aspergillosis caused by Aspergillus fumigatus.
#2. Fungal detections
Externally, it is used for:
Coloring fungal diseases, post-burn skin fungal infections, respiratory Candida, Aspergillus or Cryptococcus infections, and fungal corneal ulcers.
Due to the apparent toxicity, doctors would need it for the diagnosis of established deep fungal infections (also known as culture or positive histological tests) in patients with critically progressive diseases.
#3. Cell cultivation in the lab
Lab scientists use it to prevent the cell culture contamination of yeast and multicellular fungi.
It changes the fungal plasma membrane permeability so the fungi will not grow there.
Caution: it is not allowed to be used in patients who have no obvious clinical signs of fungal infection but only show positive skin or serum tests.
What Are Amphotericin B Side Effects?
Its common side effects include fevers, chills, headaches, loss of appetite, nausea, vomiting, etc.
Intravenous medications could induce thrombophlebitis.
Intrathecal injections can cause pain in your back and lower limbs.
It is toxic to the kidney and can cause proteinuria and tubular urine.
Doctors have suggested stopping the medication When urea nitrogen is >20mg/dl or creatinine >3mg/dl.
Or you have to lower the dose according to the advice from your doctor.
Other side effects may include declining numbers of white blood cells; instability of anemia and blood pressure; liver damage; diplopia; peripheral neuritis; rash.
During the process of medication, some patients may experience accelerated heart rate or ventricular fibrillation.
Those symptoms are most likely related to the high dose or fast injection.
There are liposomal injections or lipid complexes available in the market to cause fewer side effects.
Those dosages can greatly improve its safety and efficacy.
How To Transport and Store Amphotericin B Powder?
Amphotericin b is very sensitive to light, make sure to avoid direct sunlight during transportation and storage.
Transport Conditions: It is a safe and common chemical. Not dangerous.
According to testing results from DGM, it is said as below:
According to IATA DGR Special Provision A3, it is classified as “Not Restricted, as per Special Provision A3”.
As an antibiotic, it is highly recommended to be shipped at low temperatures.
First thing first, there are two GRADES and three TYPES of amphotericin b powder for different dosage forms. shipping temperature and storage conditions are slightly different.
For Oral Grade or conventional type.
For the conventional type, we can ship it at room temperature but store it under a temperature of 2~8 Degrees Celsius.
Please keep it sealed and protected from light and moisture during your storage.
If you want to weigh some during the storage, make sure the sample doesn’t absorb moisture.
As we all know that a low-temperature chemical will draw moisture into the air. To avoid it:
1) you can weigh the sample after the whole package is back to room temperature naturally.
2) Weigh it under a moisture-free fume-hood if it is weighed under 2~8 degrees.
This type of powder is suitable to manufacture oral dosages and topical formulations, such as tablets, capsules, creams, emulsions, gels, ear drops, ointments, or some veterinary formulations.
For Injection Grades: (Liposomal type and non-liposomal type)
For the shipping and storage of injection-grade, especially the liposomal grade, you have to take extra precautions.
You can not ship it at room temperature like conventional grade but have to transport it by cold-chain shipping methods.
Estimate how many days it will take to deliver it, add enough ice bags to keep it cool, at the same temperature we store it, 2~8 Degrees Celsius.
Of all those three grades, the liposomal type is the most expensive one and it has the highest potency.
We have to refine it by recrystallization at least twice to get it.
