Clarithromycin EP Impurity B

Clarithromycin EP Impurity B is a defined impurity of clarithromycin, a macrolide antibiotic used against respiratory and skin infections, and it carries a designation from the European Pharmacopoeia impurity naming scheme for the drug substance. Impurity standards of this type allow pharmaceutical analysts to check that a chromatographic system separates the parent antibiotic from its related substances and to assign identity to peaks observed in stability and release testing. Common applications are method development and validation for related-substance HPLC or LC-MS methods, system suitability checks, peak identification and quantitative estimation of the impurity in drug substance and drug product. The material has the formula C37H67NO13 and a molecular weight of 733.93 and is described as a white to off-white solid. Storage at -20 °C ± 5 °C and shipment on ice packs are recommended, and pack sizes spanning 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 40 mg, 50 mg, 60 mg, 100 mg and 150 mg can be provided. Requests for a quotation or further data are welcome.
Also known as
Clarithromycin Impurity B. Further pharmacopoeial and trivial names are recorded on the certificate of analysis.
Pack sizes and lead time
| Pack size | Availability | Quote |
|---|---|---|
| 10 mg | In stock | |
| 15 mg | 10 days | |
| 20 mg | 10 days | |
| 25 mg | 10 days | |
| 30 mg | 10 days | |
| 40 mg | 10 days | |
| 50 mg | 10 days | |
| 60 mg | 10 days | |
| 100 mg | 10 days | |
| 150 mg | 21 days |
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: -20℃±5℃, Shipping with Ice Packs.
Frequently asked questions
Is a certificate of analysis (COA) available for Clarithromycin EP Impurity B?
Yes. A batch-specific COA and the MSDS are issued for every lot of Clarithromycin EP Impurity B (catalogue number C4X-100218). Use the COA link on this page, or email [email protected] 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 10 mg are held in stock and typically ship within 1–2 working days Other sizes (15 mg, 20 mg, 25 mg, 30 mg, 40 mg, 50 mg, 60 mg, 100 mg, 150 mg) are quoted with a lead time of approximately 10 days, 21 days.
How is the purity of Clarithromycin EP Impurity B 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 [email protected] with the target quantity and required delivery date.
How is Clarithromycin EP Impurity B shipped?
Shipping conditions for this item: Shipping with Ice Packs. Shipments are packed to maintain the specified storage condition, and the SDS is provided for transport classification.



