Clarithromycin 81103-11-9

98.5% up by HPLC, EP/USP/IP

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Product Information

Product name	Clarithromycin
CAS No.	81103-11-9
Molecular Formula	C₃₈H₆₉NO₁₃
Molecular Weight	747.965
Quality Standard	98.5% up by HPLC, EP/USP/IP
Appearance	White to off-white,crystalline powder

COA

Test Items	Specifications	Results
Appearance	White to off-white,crystalline powder	White crystalline powder
Solubility	Practically insoluble in water,soluble in acetone or mcthylene chloride, slighly soluble in methanol, slightly soluble in anhydrous ethanol, acetonitrile and pH of 2-5 of phosphate buffer.	Conforms
Identification	IR: Corresponding to RS	Conforms
Identification	HPLC: Corresponding to the principle peak	Conforms
Appearance of solution	Clear or not more opalescent than reference suspension II;	Clear
Appearance of solution	Not more colored than reference solution Y7	Colorless
Optical Rotation	-94°~ -102°	-99°
pH	8.0 ~10.0	8.5
Crystallinity	The particles show birefringence (interferencc colors) and extinction position	Conforms
Water Determination	≤2.0%	0.6%
Residue on Ignition	≤ 0.2%	0.08%
Heavy metals	≤ 20ppm	Conforms
Residual solvents	Methanol ≤ 3000ppm	ND
	Ethanol ≤ 5000ppm	ND
	Methylene dichloride ≤ 600ppm	ND
Organic impurities	Any individual impurity ≤ 1.0%	Conforms
	Any unknown individual impurity ≤ 0.10%	ND
	Impurities exceed 0.4% ≤ 4	1
	Total impurities ≤ 3.5%	1.2%
Assay (by HPLC)	96.5%~102.0%(of C₃₈H₆₉NO₁₃on anhydrous basis)	98.9%
Conclusion	It conforms to all the USP-NF2024/EP11.0/IP2022

Usage

Clarithromycin, a powerful macrolide antibiotic, remains a vital weapon against a wide spectrum of bacterial infections. It is highly effective in treating respiratory tract infections (including sinusitis, bronchitis, and pneumonia), skin and soft tissue infections, and certain types of gastric ulcers caused by Helicobacter pylori. Its efficacy, coupled with generally good tolerability, makes clarithromycin a cornerstone in infectious disease management.

The manufacturers in China have invested significantly in advanced synthetic chemistry and rigorous GMP certified clarithromycin production. This commitment ensures the production of pharmaceutical grade clarithromycin and high quality clarithromycin API meeting stringent international pharmacopoeial standards (USP, EP,IP). Chinese manufacturers leverage sophisticated purification processes to guarantee exceptional clarithromycin purity, alongside significant production scale that fosters reliable supply chains and highly competitive pricing clarithromycin.