Azithromycin EP Impurity O

Azithromycin EP Impurity O belongs to the family of related substances defined for the macrolide antibiotic azithromycin, a fifteen-membered azalide used against a broad range of respiratory and skin infections. The impurity carries the letter designation O and has the molecular formula C39H74N2O12 with a molecular weight of 763.01, which places it among the higher-mass macrolide degradants and process-related substances encountered in azithromycin drug substance. Quality control groups rely on characterised impurity standards of this kind to develop and validate related-substance methods, to assign retention times during peak identification, and to prepare calibration solutions for quantitation against a pharmacopoeial limit. Working with a defined single impurity removes the ambiguity that arises when degradant peaks are identified only by relative retention. The solid is off-white and should be stored at 2°C to 8°C; transport is arranged at room temperature. Pack sizes on the list range from 1 mg through 5, 10, 20, 25, 30, 40, 50, 80, 100 and 150 mg. Ask for a quotation or further documentation to support method set-up.
Also known as
Azithromycin Impurity O; Azithromycin EP Impurity O. Further pharmacopoeial and trivial names are recorded on the certificate of analysis.
Pack sizes and lead time
| Pack size | Availability | Quote |
|---|---|---|
| 1 mg | In stock | |
| 5 mg | In stock | |
| 10 mg | In stock | |
| 20 mg | In stock | |
| 25 mg | 10 days | |
| 30 mg | 10 days | |
| 40 mg | 10 days | |
| 50 mg | 10 days | |
| 80 mg | On request | |
| 100 mg | 10 days | |
| 150 mg | On request |
What the documents contain
- Certificate of analysis — issued per lot: catalogue and lot number, the value assigned to the material and the analytical basis for it.
- Safety data sheet — supplied for the catalogue item, and the basis for the transport classification used on the shipment.
- Storage and shipping conditions for this item: 2℃ ~ 8℃, Shipping at Room Temperature.
Frequently asked questions
Is a certificate of analysis (COA) available for Azithromycin EP Impurity O?
Yes. A batch-specific COA and the MSDS are issued for every lot of Azithromycin EP Impurity O (catalogue number C4X-100320). Use the COA link on this page, or email chao.lu@cato-chem.com with the lot number printed on your label and we will send the matching document.
What pack sizes and lead times are offered?
Pack sizes 1 mg, 5 mg, 10 mg, 20 mg are held in stock and typically ship within 1–2 working days Other sizes (25 mg, 30 mg, 40 mg, 50 mg, 100 mg) are quoted with a lead time of approximately 10 days.
How is the purity of Azithromycin EP Impurity O documented?
Purity is determined per batch and stated on the COA together with the analytical data used for its assignment. If your method requires a specific grade or a particular pharmacopoeial naming, tell us the requirement when you enquire and we will confirm suitability.
Can you supply a larger quantity or a custom synthesis?
Yes. Quantities above the listed pack sizes are quoted on request, and custom synthesis or isolation from related starting materials can be discussed for compounds not held in stock. Contact chao.lu@cato-chem.com with the target quantity and required delivery date.
How is Azithromycin EP Impurity O shipped?
Shipping conditions for this item: Shipping at Room Temperature. Shipments are packed to maintain the specified storage condition, and the SDS is provided for transport classification.


