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PHR1610

Erythromycin Ethylsuccinate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Erythromycin ethyl succinate

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About This Item

Empirical Formula (Hill Notation):
C43H75NO16
CAS Number:
1264-62-6
Molecular Weight:
862.05
NACRES:
NA.24
PubChem Substance ID:
329823507
UNSPSC Code:
41116107
EC Number:
215-033-8
MDL number:
MFCD00084692

Key Documents

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Product Name

Erythromycin Ethylsuccinate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

NSYZCCDSJNWWJL-UHFFFAOYSA-N

InChI

1S/C43H75NO16/c1-15-29-43(11,52)36(48)24(5)33(47)22(3)20-41(9,51)38(25(6)34(26(7)39(50)57-29)59-32-21-42(10,53-14)37(49)27(8)56-32)60-40-35(28(44(12)13)19-23(4)55-40)58-31(46)18-17-30(45)54-16-2/h22-29,32,34-38,40,48-49,51-52H,15-21H2,1-14H3

SMILES string

CCOC(=O)CCC(=O)OC1C(CC(C)OC1OC2C(C)C(OC3CC(C)(OC)C(O)C(C)O3)C(C)C(=O)OC(CC)C(C)(O)C(O)C(C)C(=O)C(C)CC2(C)O)N(C)C

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to USP 1245008

API family

erythromycin

CofA

current certificate can be downloaded

packaging

pkg of 250 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

Quality Level

300

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Analysis Note

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

Application

Erythromycin Ethylsuccinate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.
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.

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.

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.
To see an example of a Certificate of Analysis for this material enter LRAA4726 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H317,H334

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

Storage Class

11 - Combustible Solids

wgk

WGK 2

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
This item has

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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Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form.
Kamarei F, et al.
Arabian Journal of Chemistry, 7(6), 1079-1085 (2014)
Determination of erythromycin and related substances in enteric-coated tablet formulations by reversed-phase liquid chromatography.
Wardrop J, et al.
Journal of Pharmaceutical Sciences, 89(9), 1097-1105 (2000)
High performance thin layer chromatographic determination of erythromycin in pharmaceutical preparations.
Liawruangrath B and Liawruangrath S
Chromatographia, 54(5-6), 405-408 (2001)

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