PHR1127

Amoxicillin trihydrate

Pharmaceutical Secondary Standard; Certified Reference Material

• Empirical Formula (Hill Notation): C₁₆H₁₉N₃O₅S · 3H₂O
• CAS Number: 61336-70-7
• Molecular Weight: 419.45
• Beilstein: 7507120
• MDL number: MFCD00072029
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823148
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 19; traceable to Ph. Eur. A0800000; traceable to USP 1031503
• API family: amoxicillin
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• SMILES string: O.O.O.CC1(C)S[C@@H]2[C@H](NC(=O)[C@H](N)c3ccc(O)cc3)C(=O)N2[C@H]1C(O)=O
• InChI: 1S/C16H19N3O5S.3H2O/c1-16(2)11(15(23)24)19-13(22)10(14(19)25-16)18-12(21)9(17)7-3-5-8(20)6-4-7;;;/h3-6,9-11,14,20H,17H2,1-2H3,(H,18,21)(H,23,24);3*1H2/t9-,10-,11+,14-;;;/m1.../s1
• InChI key: MQXQVCLAUDMCEF-CWLIKTDRSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Amoxicillin trihydrate is a oral semisynthetic penicillin,[1] which shows antibacterial activity against Gram positive and and a limited range of Gram-negative organisms. Its mode of action involves the inhibition of bacterial cell wall synthesis.[2]

Application

Amoxicillin trihydrate may be used pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations[1] using liquid chromatography technique[1] and spectrophotometric technique.[2]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB3723 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08
• Signal Word: Danger
• Hazard Statements: H317,H334
• Precautionary Statements: P261 - P272 - P280 - P284 - P302 + P352 - P333 + P313
• Hazard Classifications: Resp. Sens. 1 - Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable