Amoxicillin EP Impurity H

Name: Amoxicillin EP Impurity H
Brand: Vaqora Chemicals
SKU: VQ-020802

About Amoxicillin EP Impurity H

Amoxicillin EP Impurity H (CAS 205826-86-4) is a pharmacopeial impurity of Amoxicillin offered by Vaqora Chemicals. Formula C13H17NO4, molecular weight 251.28 g/mol. The IUPAC name is (2R)-2-(2,2-dimethylpropanoylamino)-2-(4-hydroxyphenyl)acetic acid. Common synonyms include Amoxicillin Trihydrate - Impurity H and Amoxicillin Impurity H.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

As a characterised impurity of Amoxicillin, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

We offer Amoxicillin EP Impurity H 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 Amoxicillin

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

Amoxicillin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Amoxicillin EP Impurity H
Catalogue No.	VQ-020802
CAS Number	205826-86-4
IUPAC name	(2R)-2-(2,2-dimethylpropanoylamino)-2-(4-hydroxyphenyl)acetic acid
Molecular formula	C₁₃H₁₇NO₄
Molecular weight	251.28 g/mol
Exact mass	251.1158
Grade	Reference Standard
HSN code	38229090
InChIKey	BSXQHKOBFTYRJX-SNVBAGLBSA-N
SMILES	CC(C)(C)C(=O)N[C@H](C1=CC=C(C=C1)O)C(=O)O
PubChem CID	71587634

Physical properties
Physical form	Solid
LogP (XLogP3)	1.9
H-bond donors / acceptors	3 / 4
TPSA	86.6 Å²
Synonyms	Amoxicillin Trihydrate - Impurity H, Amoxicillin EP Impurity H, amoxicillin USP rc h, 2-((2,2-Dimethylpropanoyl)amino)-2-(4-hydroxyphenyl)acetic acid, (2R)-, (2R)-2-((2,2-dimethylpropanoyl)amino)-2-(4-hydroxyphenyl)acetic acid, (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2-(4-hydroxyphenyl)acetic Acid, Benzeneacetic acid, alpha-((2,2-dimethyl-1-oxopropyl)amino)-4-hydroxy-, (R)-, Benzeneacetic acid, alpha-[(2,2-dimethyl-1-oxopropyl)amino]-4-hydroxy-, (alphaR)-, (R)-2-(4-hydroxyphenyl)-2-pivalamidoacetic acid, Amoxicillin Impurity H, Amoxicillin trihydrate impurity H, (R)-2-(4-Hydroxyphenyl)-2-pivalamidoacetic acid (Amoxicillin Impurity)

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H302Harmful if swallowed

Precautionary statements: P264, P270, P301 + P317, P330, 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 Amoxicillin EP Impurity H?

The CAS Registry Number of Amoxicillin EP Impurity H is 205826-86-4. It is also known as Amoxicillin Trihydrate - Impurity H, Amoxicillin EP Impurity H, amoxicillin USP rc h.

What is the molecular formula and molecular weight of Amoxicillin EP Impurity H?

Amoxicillin EP Impurity H has the molecular formula C13H17NO4 and a molecular weight of 251.28 g/mol. Its IUPAC name is (2R)-2-(2,2-dimethylpropanoylamino)-2-(4-hydroxyphenyl)acetic acid.

What is Amoxicillin EP Impurity H used for?

Amoxicillin EP Impurity H is supplied as a characterised reference material related to Amoxicillin. 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 Amoxicillin EP Impurity H can I order?

We supply Amoxicillin EP Impurity H 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 Amoxicillin EP Impurity H?

Yes. Every lot of Amoxicillin EP Impurity H 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 Amoxicillin EP Impurity H be shipped internationally?

Yes. Amoxicillin EP Impurity H 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.