Clarithromycin EP Impurity N

About Clarithromycin EP Impurity N

Clarithromycin EP Impurity N is a pharmacopeial impurity of Clarithromycin carrying the CAS registry number 144604-03-5. The compound has the formula C38H67NO12, corresponding to a molecular weight of 729.9 g/mol. Common synonyms include Clarithromycin - Impurity N and Clarithromycin Impurity N.

It is supplied as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. It carries the GHS signal word “Warning” with 3 hazard statements. Review the Safety Data Sheet before use.

Pharmaceutical QC and development laboratories use this impurity standard of Clarithromycin to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

We offer Clarithromycin EP Impurity N in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Clarithromycin

View every impurity, metabolite and intermediate we list for Clarithromycin.

Clarithromycin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Clarithromycin EP Impurity N
Catalogue No.	VQ-021177
CAS Number	144604-03-5
IUPAC name	(3R,4S,5S,6R,7R,9R,11E,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-13-hydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradec-11-ene-2,10-dione
Molecular formula	C₃₈H₆₇NO₁₂
Molecular weight	729.9 g/mol
Exact mass	729.4663
Grade	Reference Standard
HSN code	38229090
InChIKey	XBRPMQCVVSGOJB-LUHVZOSXSA-N
SMILES	CC[C@@H]1[C@@](/C=C(/C(=O)[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)C)O)(C)OC)C)\C)(C)O
PubChem CID	12148839

Physical properties
Physical form	Solid
LogP (XLogP3)	3.9
H-bond donors / acceptors	3 / 13
TPSA	163 Å²

Safety & hazard information (GHS)

Harmful / irritant

Environmental hazard

Signal word: Warning

Hazard statements

H302Harmful if swallowed
H400Very toxic to aquatic life
H410Very toxic to aquatic life with long lasting effects

Precautionary statements: P264, P270, P273, P301 + P317, P330, P391, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Clarithromycin EP Impurity N?

The CAS Registry Number of Clarithromycin EP Impurity N is 144604-03-5. It is also known as Clarithromycin - Impurity N, Clarithromycin Impurity N, (10E)-10,11-Didehydro-11-deoxy-6-O-methylerythromycin.

What is the molecular formula and molecular weight of Clarithromycin EP Impurity N?

Clarithromycin EP Impurity N has the molecular formula C38H67NO12 and a molecular weight of 729.9 g/mol.

What is Clarithromycin EP Impurity N used for?

Clarithromycin EP Impurity N is supplied as a characterised reference material related to Clarithromycin. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Clarithromycin EP Impurity N can I order?

We supply Clarithromycin EP Impurity N in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Clarithromycin EP Impurity N?

Yes. Every lot of Clarithromycin EP Impurity N is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Clarithromycin EP Impurity N be shipped internationally?

Yes. Clarithromycin EP Impurity N is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.