1: Product Name: Azithromycin Dihydrate (EP 12/USP/IP 2022)
CAS No.: 117772-70-0
2: What is our specification ?
|
Item |
Specification |
|
Appearance |
White or almost white powder. |
|
Identification |
IR: The infrared absorption spectrum of the sample complies with the reference standard. |
|
HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. |
|
|
Solubility |
Practically insoluble in water, freely soluble in anhydrous ethanol and in methylene chloride. |
|
Appearance of Solution |
Clear and colorless (0.500g in 50ml of anhydrous ethanol) |
|
Specific Rotation (20℃) |
-45.0° ~ -49.0° |
|
Crystallinity |
Meets the requirements |
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pH |
9.0-11.0 (2 mg/mL in a 1:1 mixture of methanol and water) |
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Moisture |
4.0%-5.0% |
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Residue on Ignition |
≤ 0.2% |
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Related Substances (HPLC) |
Azaerythromycin A (Impurity A) ≤ 0.5% |
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Azithromycin B (Impurity B) ≤ 1.0% |
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Azithromycin C (Impurity C) ≤ 0.5% |
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Sum of Impurities D, J and Q ≤ 0.3% |
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3'-N-[[4-(acetylamino)phenyl]sulfonyl]-3',3'- didenethylazithromycin ≤ 0.15% |
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3'-(N,N-dimethyl) azithromycin (Impurity E) ≤ 0.5% |
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Azithromycin related compound F (Impurity F) ≤ 0.5% |
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3'-[N-demethyl-3'-N-[4-(methylphenyl)sulfonyl]] azithromycin (Impurity G) ≤ 0.2% |
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N-demethylazithromycin (Impurity I) ≤ 0.5% |
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3'-N-[4-(Acetylamino) phenyl)sulfonyl]-3'-denethylazithromycin (Impurity H) ≤ 0.5% |
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Azithromycin N-oxide (Impurity L) ≤ 0.5% |
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3'-[N,N-Dimethyl)-3'-[N-formyl]azithromycin (Impurity M) ≤ 0.5% |
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3'-[De(dimethylamino)-3'-oxoazithromycin (Impurity N) ≤ 0.5% |
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2-Demethyl-2-propylazithromycin (Impurity O) ≤ 0.5% |
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Azithromycin impurity P (Impurity P) ≤ 0.2% |
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Erythromycin A iminoether ≤ 0.5% |
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Erythromycin A oxime ≤ 0.5% |
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Any other impurity ≤ 0.2% |
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Total impurities ≤ 3.0% |
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Residual Solvents |
Methylene chloride ≤ 600ppm |
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Acetone ≤ 5000ppm |
|
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Methanol ≤ 3000ppm |
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Ethanol ≤ 5000ppm |
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|
Assay (HPLC, on anhydrous basis) |
960 μg/mg-1020 μg/mg |
3:What is the main effects of Azithromycin Dihydrate (EP 12/USP/IP 2022)+CAS 117772-70-0?
Potent antibacterial activity
Treat respiratory infections
Anti-inflammatory and immunomodulatory
Long tissue half-life
4: What is the usage of Azithromycin Dihydrate (EP 12/USP/IP 2022)+CAS 117772-70-0?
Used as an active pharmaceutical ingredient.
5: What will you get from gihi chemicals except higher quality products?
Gihi Chemicals Co.,Limited, is a professional manufacturer with
3strong research and development lab centers + 4 standardized production workshops,with ISO9001 & FDA certificate & CE certificates.
Except the high quality product, your team will get the following 4 support:
5.1): Factory direct sales, China's lower price, free sample is available.
5.2): COA, TDS, SDS and other testing spectrum are available at any time.
5.3):ISO9001, FDA, CE certificate, 3 labs and 4 factories, to insure the higher quality.
5.4): Large quantity in stock, prompt delivery from warehouse, 24h professional service.
6:Where to buy bulk Azithromycin Dihydrate (EP 12/USP/IP 2022)+CAS 117772-70-0?
Send an inquiry email to us : sales@gihichem.com
Our professional team will reply to you within 6 hours.
7:Why Choose gihi chemicals for Your trustful supplier?
●Extensive Selection: Our 3 labs and 4 factories ensure every year, we could produce more than 100 new chemical structures every year.
●GMP-Compliant Facilities: Our 4 professional factories comply with strict GMP (Good Manufacturing Practice) guidelines, ensuring the highest quality and safety standards throughout production.
●Rigorous Certifications: All ingredients are certified with HACCP, ISO, FDA,CE certificates.
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