Amikacin EP Impurity I

Name: Amikacin EP Impurity I
Brand: Vaqora Chemicals
SKU: VQ-021540

About Amikacin EP Impurity I

Amikacin EP Impurity I (CAS 40371-51-5) is a pharmacopeial impurity of Amikacin offered by Vaqora Chemicals. Formula C4H9NO3, molecular weight 119.12 g/mol. Its systematic (IUPAC) name is (2S)-4-amino-2-hydroxybutanoic acid. Common synonyms include Amikacin - Impurity I and 4-Amino-2-hydroxybutyric acid, (S)-(-)-.

The product is provided as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. Under GHS it is labelled “Warning”, so handle it with suitable PPE and consult the SDS.

Pharmaceutical QC and development laboratories use this impurity standard of Amikacin to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

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

Industries

Related to Amikacin

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

Amikacin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Amikacin EP Impurity I
Catalogue No.	VQ-021540
CAS Number	40371-51-5
IUPAC name	(2S)-4-amino-2-hydroxybutanoic acid
Molecular formula	C₄H₉NO₃
Molecular weight	119.12 g/mol
Exact mass	119.0582
Grade	Reference Standard
HSN code	38229090
InChIKey	IVUOMFWNDGNLBJ-VKHMYHEASA-N
SMILES	C(CN)[C@@H](C(=O)O)O
PubChem CID	2733929

Physical properties
Physical form	Solid
LogP (XLogP3)	-3.7
H-bond donors / acceptors	3 / 4
TPSA	83.6 Å²
Synonyms	Amikacin - Impurity I, 4-Amino-2-hydroxybutyric acid, (S)-(-)-, (S)-4-amino-2-hydroxybutanoic acid, (S)-4-Amino-2-hydroxybutyric acid, Amikacin impurity I, Butanoic acid, 4-amino-2-hydroxy-, (2S)-, 4-amino-(2s)-hydroxybutyric acid, L-(-)-4-Amino-2-hydroxybutyric acid, Butanoic acid, 4-amino-2-hydroxy-, (S)-, L-4-amino-2-hydroxybutyric acid, (2S)-4-amino-2-hydroxybutyric acid, L-gamma-Amino-alpha-hydroxybutyric acid

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary statements: P261, P264, P264 + P265, P271, P280, P302 + P352, P304 + P340, P305 + P351 + P338, P319, P321, P332 + P317, P337 + P317, P362 + P364, P403 + P233, P405, 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 Amikacin EP Impurity I?

The CAS Registry Number of Amikacin EP Impurity I is 40371-51-5. It is also known as Amikacin - Impurity I, 4-Amino-2-hydroxybutyric acid, (S)-(-)-, (S)-4-amino-2-hydroxybutanoic acid.

What is the molecular formula and molecular weight of Amikacin EP Impurity I?

Amikacin EP Impurity I has the molecular formula C4H9NO3 and a molecular weight of 119.12 g/mol. Its IUPAC name is (2S)-4-amino-2-hydroxybutanoic acid.

What is Amikacin EP Impurity I used for?

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

We supply Amikacin EP Impurity I 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 Amikacin EP Impurity I?

Yes. Every lot of Amikacin EP Impurity I 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 Amikacin EP Impurity I be shipped internationally?

Yes. Amikacin EP Impurity I 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.