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Azithromycin EP Impurity K

CAS 612534-95-9 Cat. no. C4X-100311 Formula C38H70N2O13 MW 762.97 In stock
Documents on file — click to open, no login needed:Certificate of analysis (COA)Safety data sheet (SDS)
Chemical structure of Azithromycin EP Impurity K, CAS 612534-95-9
Structure of Azithromycin EP Impurity K, CAS 612534-95-9 — click to open the full-size image

Azithromycin EP Impurity K is one of the specified related substances of the macrolide antibiotic azithromycin and is described by the formula C38H70N2O13, molecular weight 762.97. Its close structural relationship to the parent antibiotic means it may co-elute with the main peak under non-optimised conditions, so a well-characterised reference material is valuable when resolving and identifying related substances in azithromycin raw material and finished dosage forms. Laboratories typically use it to establish system suitability, to confirm peak purity, and to build calibration curves for impurity quantitation during stability studies and batch release testing. The material is an off-white solid that should be kept at -20°C ± 5°C, with shipments prepared using ice packs. Listed pack sizes include 1 mg, 2 mg, 5 mg, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 50 mg, 100 mg and 200 mg. Request a quote or the accompanying documentation for your method requirements.

Also known as

Azithromycin Impurity K. Further pharmacopoeial and trivial names are recorded on the certificate of analysis.

Pack sizes and lead time

Pack sizeAvailabilityQuote
1 mgIn stock
2 mgIn stock
5 mgIn stock
10 mgIn stock
20 mgIn stock
25 mgIn stock
30 mgIn stock
35 mg10 days
50 mg10 days
100 mgOn request
200 mgOn request
Content and purity for each pack size are stated per lot on the certificate of analysis. Prices are quoted per enquiry so that pack size, documentation and shipping requirements can be confirmed together — no price is published on this site.

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 Azithromycin EP Impurity K?

Yes. A batch-specific COA and the MSDS are issued for every lot of Azithromycin EP Impurity K (catalogue number C4X-100311). 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, 2 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 (35 mg, 50 mg) are quoted with a lead time of approximately 10 days.

How is the purity of Azithromycin EP Impurity K 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 Azithromycin EP Impurity K 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.

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