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Azithromycin dihydrate is the common crystalline form of azithromycin, a macrolide antibiotic used for respiratory and other infections caused by susceptible bacteria, Mycoplasma, and Chlamydia. Its main selling points are once-daily dosing and strong tissue penetration.
Uses: pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis, pneumonia; chlamydial urethritis/cervicitis; some skin and soft-tissue infections.
Advantages: broad spectrum against Gram-positive, some Gram-negative, and atypical pathogens; concentrates in infected tissues and inside cells; long half-life (~68 hours) allows once-daily dosing for only 3–5 days.
Precautions: prescription only. Common side effects include diarrhoea, nausea, abdominal pain, and rash. Avoid if allergic to erythromycin or other macrolides, or with severe liver impairment.
Specifications of Azithromycin dihydrate CAS 117772-70-0 COA:
Items | Specifications | Results |
Appearance | White or almost white powder | White powder |
Identification Infrared absorption | Corresponds to RS. | Corresponds to RS. |
Liquid chromatograph | The retention time of azithromycin peak of the sample solution corresponds to that of the standard solution obtained in the Assay. | The retention time of azithromycin peak of the sample solution corresponds to that of the standard solution obtained in the Assay. |
Optical rotation | -45°~ -49° | -47° |
Crystallinity | Meets the requirement. | Meets the requirement. |
pH | 9.0~11.0 | 9.9 |
Water | 4.0 ~ 5.0% | 4.6% |
Related substances(Procedure 2)(HPLC) | ||
AzithromycinN-oxide | ≤0.5% | N.D. |
3’-(N,N-Didemethyl) azithromycin(aminoazithromycin) | ≤0.5% | |
3’-(N,N-Didemethyl)-3’-N-formyl-azithromycin | ≤0.5% | N.D. |
Azithromycin related compound F | N.D. | |
Desosaminylazithromycin | ≤0.3% | N.D. |
3’-N-{[4-(Acetylamino)phenyl]sulfonyl}-3’,3’-didemethylazithromycin | ≤0.15% | N.D. |
N-Demethylazithromycin | ≤0.7% | N.D. |
Azithromycin C(3’’-O-demethylazithromycin) | ≤0.5% | N.D. |
3'-De(dimethylamino)-3'-oxoazithromycin | ≤0.5% | N.D. |
3'-N-{[4-(Acetylamino)phenyl]sulfonyl}-3'-demethylazithromycin | ≤0.5% | N.D. |
Azaerythromycin A | ≤0.5% | N.D. |
Azithromycin impurity P | ≤0.2% | N.D. |
2-Desethyl-2-propyl-azithromycin | ≤0.5% | 0.10% |
3'-N-Demethyl-3'-N-[(4-methylphenyl)sulfonyl]azithromycin | ≤0.5% | N.D. |
3-Deoxyazithromycin(azithromycin B) | ≤1.0% | 0.19% |
Erythromycin A iminoether | ≤0.5% | N.D. |
Erythromycin A oxime | ≤0.5% | N.D. |
Any unspecified impurity | ≤0.2% | N.D. |
Total impurities | ≤3.0% | 0.29% |
Residue on ignition | ≤0.3% | 0.05% |
Assay (HPLC, on anhydrous basis) | 945 ~ 1030 μg/mg | 1000μg/mg |
Additional test: | ||
Residual solvent (GC) | ||
Methanol | ≤3000 ppm | N.D. |
Acetone | ≤5000 ppm | 413ppm |
Dichloromethane | ≤600 ppm | N.D. |
Bulk density | 0.38g/ml | |
Tapped density | 0.6g/ml | |
Particle size(D0.1) | 1.8μm | |
D0.5 | 13.2μm | |
D0.9 | 47.9μm | |
Conclusion | The product conforms to the above specifications. | |

Product Name:Azithromycin dihydrate
CAS:117772-70-0
MF:C38H74N2O13
Melting point :126 ℃
form:powder
color:White or almost white
Uses:
Azithromycin Dihydrate is the most common crystalline (salt/hydrate) form of azithromycin, a macrolide antibiotic. It is mainly used to treat respiratory tract, skin and other infections caused by susceptible bacteria and atypical pathogens such as Mycoplasma and Chlamydia. Its key advantages are low dosing frequency and strong tissue penetration.
Main Uses (Indications)
According to drug labeling/regulatory information, azithromycin is mainly used for infections caused by susceptible organisms, including:
Respiratory tract infections: pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis and various types of pneumonia.
Other infections: urethritis and cervicitis caused by Chlamydia trachomatis and similar organisms, as well as some skin and soft-tissue infections.
Key Selling Points / Advantages
Broad antibacterial spectrum — effective against many Gram-positive bacteria, some Gram-negative bacteria, and atypical pathogens such as Mycoplasma and Chlamydia.
Strong tissue penetration — after absorption, the drug distributes rapidly and widely into tissues; concentrations in infected tissues are far higher than in non-infected tissues, and it achieves high intracellular concentrations, giving strong antibacterial activity.
Long half-life, short course of treatment — the elimination half-life is approximately 68 hours, so therapeutic levels are maintained in the body for a long time. This allows a simplified regimen of once daily for only 3–5 days, unlike traditional antibiotics that must be taken three or four times a day.
Precautions
Azithromycin is a prescription medicine and should be purchased and used only with a doctor's prescription after a clear diagnosis. Common adverse reactions during treatment include gastrointestinal discomfort such as diarrhoea, nausea and abdominal pain, as well as skin reactions such as rash. It must not be used by patients with a history of hypersensitivity to erythromycin or other macrolides, or those with severe hepatic impairment.



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FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.



Name:Wuhan Fortuna Chemical Co.,Ltd
Category:Others
Trade Category: Trading Company
Employees: 11 - 50 People
Address: Room 2015, No.2 Building, Kaixin Mansion No.107
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Azithromycin dihydrate with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Azithromycin dihydrate.
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