PHR1596

Pemetrexed

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Pemetrexed disodium heptahydrate
• Empirical Formula (Hill Notation): C₂₀H₁₉N₅Na₂O₆ · 7H₂O
• CAS Number: 357166-29-1
• Molecular Weight: 597.48
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0001539
• API family: pemetrexed
• 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
• InChI: 1S/C20H21N5O6.2Na.7H2O/c21-20-24-16-15(18(29)25-20)12(9-22-16)6-3-10-1-4-11(5-2-10)17(28)23-13(19(30)31)7-8-14(26)27;;;;;;;;;/h1-2,4-5,9,13H,3,6-8H2,(H,23,28)(H,26,27)(H,30,31)(H4,21,22,24,25,29);;;7*1H2/q;2*+1;;;;;;;/p-2/t13-;;;;;;;;;/m0........./s1
• InChI key: QJVSMHJWAOSBMD-MYXYZBIASA-L

Description

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.
Pemetrexed is an anionic anticancer drug with a narrow therapeutic index. As a folate anti metabolite, it acts as an inhibitor of thymidylate synthase. It can act effectively against a broad-spectrum of solid tumors such as non-small-cell lung and breast cancers in clinical trials. It is also effective against both dihydrofolate reductase and glycinamide ribonucleotide formyl transferase.

Application

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 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 LRAA4712 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Statements: H315,H341,H360FD,H372
• Precautionary Statements: P202 - P260 - P264 - P280 - P302 + P352 - P308 + P313
• Hazard Classifications: Muta. 2 - Repr. 1A - Skin Irrit. 2 - STOT RE 1
• Target Organs: Blood,Immune system,Testes
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable