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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:
61336-70-7
Molecular Weight:
419.45
Beilstein:
7507120
MDL number:
MFCD00072029
UNSPSC Code:
41116107
PubChem Substance ID:
329823148
NACRES:
NA.24

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

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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.

related product

Product No.
Description
Pricing

1031503

Amoxicillin, United States Pharmacopeia (USP) Reference Standard

A0800000

Amoxicillin trihydrate, European Pharmacopoeia (EP) Reference Standard

Y0000889

Flucloxacillin impurity C, European Pharmacopoeia (EP) Reference Standard

Y0001521

Amoxicillin trihydrate for performance verification, European Pharmacopoeia (EP) Reference Standard

1031514

Amoxicillin Related Compound A, United States Pharmacopeia (USP) Reference Standard

1031558

Amoxicillin Related Compounds D and E Mixture, United States Pharmacopeia (USP) Reference Standard

1031605

Amoxicillin Related Compound J, United States Pharmacopeia (USP) Reference Standard

1031536

Amoxicillin Related Compound C, United States Pharmacopeia (USP) Reference Standard

1031570

Amoxicillin Related Compound G, United States Pharmacopeia (USP) Reference Standard

1031569

Amoxicillin Related Compound F, United States Pharmacopeia (USP) Reference Standard

1031525

Amoxicillin Related Compound B, United States Pharmacopeia (USP) Reference Standard

1031547

Amoxicillin Related Compound D, United States Pharmacopeia (USP) Reference Standard

1031616

Amoxicillin Related Compound H, United States Pharmacopeia (USP) Reference Standard

BP019

Amoxicillin trihydrate, British Pharmacopoeia (BP) Reference Standard

BP748

Amoxicillin impurity standard, British Pharmacopoeia (BP) Reference Standard

PHR2197

(2R)-2-Amino-2-(4-hydroxyphenyl)-acetamide, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2195

Amoxicillin Impurity H, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2193

Amoxicillin Related Compound F, Pharmaceutical Secondary Standard; Certified Reference Material

PHR9036

(+)-6-Aminopenicillanic acid, reference material

PHR2191

Amoxicillin Related Compound D, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2190

Amoxicillin Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2192

Amoxicillin Related Compound E, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2188

Amoxicillin Related Compound A

PHR2196

Amoxicillin Related Compound I

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H317,H334

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

监管及禁止进口产品

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Spectrophotometric determination of amoxicillin in pharmaceutical formulations
Unal K, et al.
Turkish Journal of Pharmaceutical Sciences, 5(1), 1-16 (2008)
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)
Adriaan Blommaert et al.
The Journal of antimicrobial chemotherapy, 68(10), 2383-2392 (2013-05-18)
Bacterial resistance to antibiotics, driven by antibiotic consumption, imposes a major threat to the effective treatment of bacterial infections. In addition to reducing the amount of antibiotics prescribed, avoiding broad-spectrum antibiotics could extend the lifetime of the current arsenal of
Allan S Lieberthal et al.
Pediatrics, 131(3), e964-e999 (2013-02-27)
This evidence-based clinical practice guideline is a revision of the 2004 acute otitis media (AOM) guideline from the American Academy of Pediatrics (AAP) and American Academy of Family Physicians. It provides recommendations to primary care clinicians for the management of
Aluma Chovel-Sella et al.
Pediatrics, 131(5), e1424-e1427 (2013-04-17)
"Ampicillin rash," a phenomenon unique to patients with Epstein-Barr virus acute infectious mononucleosis (AIM) treated with ampicillin, was first reported in the 1960s. The incidence was estimated as being between 80% and 100%, and the figures have not been reviewed
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