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Merck

PHR1528

Oxaliplatine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

[SP-4-2-(1R-trans)]-(1,2-Cyclohexanediamine-N,N′)[éthanedioate(2--)-O,O’]platine

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A propos de cet article

Formule empirique (notation de Hill) :
C8H14N2O4Pt
Numéro CAS:
61825-94-3
Poids moléculaire :
397.29
NACRES:
NA.24
PubChem Substance ID:
329823440
UNSPSC Code:
41116107
MDL number:
MFCD00866327

Principaux documents

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Nom du produit

Oxaliplatine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI

1S/C6H14N2.C2H2O4.Pt/c7-5-3-1-2-4-6(5)8;3-1(4)2(5)6;/h5-6H,1-4,7-8H2;(H,3,4)(H,5,6);/q;;+2/p-2/t5-,6-;;/m1../s1

SMILES string

O=C1O[Pt]OC1=O.N[C@@H]2CCCC[C@H]2N

InChI key

ZROHGHOFXNOHSO-BNTLRKBRSA-L

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000271
traceable to USP 1481204

API family

oxaliplatin

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.

2-30°C

Quality Level

300

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Catégories apparentées

Analysis Note

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

Application

Oxaliplatin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and electrophoresis 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.
Oxaliplatin, a third generation anti-cancer drug platinum compound, is utilized for the treatment of colorectal cancer. It exhibits a better safety profile than cisplatin (first generation) and carboplatin (second generation).

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 LRAB8974 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazardCorrosion
GHS08,GHS05

signalword

Danger

Hazard Classifications

Carc. 2 - Eye Dam. 1 - Lact. - Muta. 2 - Repr. 1B - Resp. Sens. 1B - Skin Sens. 1 - STOT RE 1

Classe de stockage

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

Certificats d'analyse (COA)

Recherchez un Certificats d'analyse (COA) en saisissant le numéro de lot du produit. Les numéros de lot figurent sur l'étiquette du produit après les mots "Lot" ou "Batch".

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Consulter la Bibliothèque de documents

Characterization of a liposome-based formulation of oxaliplatin using capillary electrophoresis: encapsulation and leakage.
Franzen U, et al.
Journal of Pharmaceutical and Biomedical Analysis, 55(1), 16-22 (2011)
Quality control of pharmaceutical formulations containing cisplatin, carboplatin, and oxaliplatin by micellar and microemulsion electrokinetic chromatography (MEKC, MEEKC).
Nussbaumer S, et al.
Journal of Pharmaceutical and Biomedical Analysis, 55(2), 253-258 (2011)
Investigation of a liposomal oxaliplatin drug formulation by capillary electrophoresis hyphenated to inductively coupled plasma mass spectrometry (CE-ICP-MS).
Nguyen TTTN, et al.
Analytical and Bioanalytical Chemistry, 402(6), 2131-2139 (2012)
Validation of a LC method for the analysis of oxaliplatin in a pharmaceutical formulation using an experimental design.
Ficarra R, et al.
Journal of Pharmaceutical and Biomedical Analysis, 29(6), 1097-1103 (2002)
L B J van Iersel et al.
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology, 40(11), 1557-1563 (2014-08-16)
To improve isolated hepatic perfusion (IHP), we performed a phase I dose-escalation study to determine the optimal oxaliplatin dose in combination with a fixed melphalan dose. Between June 2007 and July 2008, 11 patients, comprising of 8 colorectal cancer and
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