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PHR1772

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Meropenem

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Meropenem trihydrate, (1R,5S,6S)-2-[(3S,5S)-5-(dimethylaminocarbonyl)pyrrolidin-3-ylthio]-6-[(R)-1-hydroxyethyl]-1-methylcarbapen-2-em-3-carboxylic acid trihydrate
Empirical Formula (Hill Notation):
C17H25N3O5S · 3H2O
CAS Number:
119478-56-7
Molecular Weight:
437.51
MDL number:
MFCD08600005
UNSPSC Code:
41116107
PubChem Substance ID:
329823603
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001252
traceable to USP 1392454

API family

meropenem

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

O.O.O.C[C@@H](O)[C@@H]1[C@H]2[C@@H](C)C(S[C@@H]3CN[C@@H](C3)C(=O)N(C)C)=C(N2C1=O)C(O)=O

InChI

1S/C17H25N3O5S.3H2O/c1-7-12-11(8(2)21)16(23)20(12)13(17(24)25)14(7)26-9-5-10(18-6-9)15(22)19(3)4;;;/h7-12,18,21H,5-6H2,1-4H3,(H,24,25);3*1H2/t7-,8-,9+,10+,11-,12-;;;/m1.../s1

InChI key

CTUAQTBUVLKNDJ-OBZXMJSBSA-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. These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.
Meropenem belongs to the class of a semi-synthetic 1β-methylcarbapenem antibiotics. It shows an extremely broad-spectrum of antibacterial performance and is known for its high stability against renal dehydropeptidase-I (DHP-I).

Application

Lincomycin Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and peritoneal dialysis solution by spectrophotometric and various chromatography techniques.(58)
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.

Biochem/physiol Actions

Meropenem trihydrate is an ultra-broad spectrum beta-lactam antibiotic active against both Gram-positive and Gram-negative bacteria.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP 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 LRAB7853 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H317,H334

Hazard Classifications

Resp. Sens. 1 - Skin Sens. 1

WGK

WGK 3

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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Chromatographic determination of polymerized impurities in meropenem.
Cai SY and Hu CQ
Journal of Pharmaceutical and Biomedical Analysis, 37(3), 585-589 (2005)
Stability of amoxycillin, clindamycin and meropenem in peritoneal dialysis solution.
Tran MD, et al.
Journal of Pharmacy Practice and Research, 42(3), 218-222 (2012)
Ultraviolet spectrophotometry (dual wavelength and chemometric) and high performance liquid chromatography for simultaneous estimation of meropenem and sulbactam sodium in pharmaceutical dosage form.
Marwada KR, et al.
Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy, 124(3), 292-299 (2014)
Youngchang Kim et al.
Protein science : a publication of the Protein Society, 29(3), 723-743 (2019-12-18)
Emergence of Enterobacteriaceae harboring metallo-β-lactamases (MBL) has raised global threats due to their broad antibiotic resistance profiles and the lack of effective inhibitors against them. We have been studied one of the emerging environmental MBL, the L1 from Stenotrophomonas maltophilia
Emily Marsh et al.
Clinica chimica acta; international journal of clinical chemistry, 486, 265-268 (2018-08-18)
Therapeutic drug monitoring is used for aminoglycosides and vancomycin, and has been proposed for β-lactam antibiotics. Clinical blood samples in the ICU are often obtained via an existing vascular catheter rather than fresh needle phlebotomy. If antibiotics had previously been
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