PHR1772

Meropenem

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyma: 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
• Empirický vzorec (Hillův zápis): C₁₇H₂₅N₃O₅S · 3H₂O
• Číslo CAS: 119478-56-7
• Molekulová hmotnost: 437.51
• MDL number: MFCD08600005
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823603
• NACRES: NA.24

Vlastnosti

• 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

Popis

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.

Bezpečnostní informace

• pictograms: GHS08
• signalword: Danger
• hcodes: H317,H334
• pcodes: P261 - P272 - P280 - P284 - P302 + P352 - P333 + P313
• Hazard Classifications: Resp. Sens. 1 - Skin Sens. 1
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable