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PHR1127

Supelco

Amoxicillin trihydrate

Pharmaceutical Secondary Standard; Certified Reference Material

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Empirical Formula (Hill Notation):
C16H19N3O5S · 3H2O
CAS Number:
Molecular Weight:
419.45
Beilstein/REAXYS Number:
7507120
MDL number:
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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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, 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.

Application

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

pictograms

Health hazard

signalword

Danger

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

wgk_germany

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable


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Validated stability-indicating LC method for estimation of amoxicillin trihydrate in pharmaceutical dosage forms and time-dependent release formulations
Beg S, et al.
International Journal of Pharmaceutical Sciences and Nanotechnology, 4(2) (2011)
Spectrophotometric determination of amoxicillin in pharmaceutical formulations
Unal K, et al.
Turkish Journal of Pharmaceutical Sciences, 5(1), 1-16 (2008)
Yu-Hsin Lin et al.
Biomaterials, 34(18), 4466-4479 (2013-03-19)
Helicobacter pylori is a significant human pathogen that recognizes specific carbohydrate receptors, such as the fucose receptor, and produces the vacuolating cytotoxin, which induces inflammatory responses and modulates the cell-cell junction integrity of the gastric epithelium. The clinical applicability of
Enrique Gómez et al.
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 110(4), 267-273 (2013-03-29)
Although allergic drug reactions have been considered to be immediate (IgE mediated) or delayed (T-cell effector mechanisms), accelerated reactions have also been defined; however, they have not been sufficiently studied. To study the mechanisms involved in accelerated reactions to amoxicillin.
Fanny B Morel et al.
Neonatology, 103(3), 182-189 (2013-02-26)
It is suggested that antibiotherapy in infancy might program adult body composition and thus could be a determinant of obesity risk. Although not convincingly substantiated by existing literature, this assumption is plausible since antibiotics affect intestinal microbiota, whose composition in

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