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Impurity reference standards

Dicloxacillin impurity standards

For Dicloxacillin, the Zemixal catalogue holds 7 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 pharmacopoeial impurity and 1 degradation product.

7reference materials
1pharmacopoeial
1degradants
Dicloxacillin Sodium structure
Parent API

Dicloxacillin Sodium

CAS
13412-64-1
Formula
C19H16Cl2N3NaO5S
MW
492.3 g/mol
Code
ZX-003923

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Degradants1N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Dicloxacillin reference materials

Questions

Dicloxacillin impurities, answered

What Dicloxacillin reference materials are available?
The catalogue currently lists 7 compounds for Dicloxacillin, including 1 pharmacopoeial impurity and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dicloxacillin impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Dicloxacillin impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
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