Roxithromycin EP Impurity H

Roxithromycin EP Impurity H is a related substance of roxithromycin, the semi-synthetic macrolide antibiotic derived from erythromycin A. The compound is a large macrocyclic lactone with the formula C41H76N2O14 and a molecular weight of 821.05, appearing as an off-white solid. Macrolide impurities frequently differ only subtly in substitution pattern, so an authenticated standard is needed to position the impurity peak, to demonstrate separation from the main component and to show that a stability-indicating method resolves it. Analysts therefore include it in method development, forced-degradation work and system suitability checks for roxithromycin drug substance and finished product testing. Storage at -20 C +/- 5 C is stated, and consignments are shipped with ice packs to protect the material in transit. Listed pack sizes run from 1 mg to 500 mg. A quotation and the corresponding analytical documentation may be requested through the form on this page.
Also known as
Roxithromycin Impurity H. 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 | In stock | |
| 30 mg | In stock | |
| 50 mg | 10 days | |
| 100 mg | 10 days | |
| 200 mg | 10 days | |
| 250 mg | 10 days | |
| 500 mg | 10 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 Roxithromycin EP Impurity H?
Yes. A batch-specific COA and the MSDS are issued for every lot of Roxithromycin EP Impurity H (catalogue number C4X-13038). 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 1 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg are held in stock and typically ship within 1–2 working days Other sizes (50 mg, 100 mg, 200 mg, 250 mg, 500 mg) are quoted with a lead time of approximately 10 days.
How is the purity of Roxithromycin EP Impurity H 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 Roxithromycin EP Impurity H 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.


