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PHR1067

Supelco

Carbamazepine

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
5H-Dibenz[b,f]azepine-5-carboxamide
Empirical Formula (Hill Notation):
C15H12N2O
CAS Number:
Molecular Weight:
236.27
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

191-192 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 974
traceable to PhEur C0450000
traceable to USP 1093001

SMILES string

NC(=O)N1c2ccccc2C=Cc3ccccc13

InChI

1S/C15H12N2O/c16-15(18)17-13-7-3-1-5-11(13)9-10-12-6-2-4-8-14(12)17/h1-10H,(H2,16,18)

InChI key

FFGPTBGBLSHEPO-UHFFFAOYSA-N

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards.
Carbamazepine is a tricyclic lipophilic compound, with mild anticholinergic activity. It is widely used as an antiepileptic drug for the treatment of simple and complex partial tonic-clonic seizures.

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.
Carbamazepine may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using chromatography techniques.

Biochem/physiol Actions

Anticonvulsant; ligand for the GABAA receptor benzodiazepine modulatory site. Sodium channel inhibitor.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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 LRAA6055 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation markHealth hazard

Signal Word

Danger

Hazard Statements

Precautionary Statements

Hazard Classifications

Acute Tox. 4 Oral - Resp. Sens. 1 - Skin Sens. 1

Storage Class Code

13 - Non Combustible Solids

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

An ultra-sensitive LC method for the simultaneous determination of paracetamol, carbamazepine, losartan and ciprofloxacin in bulk drug, pharmaceutical formulation and human serum by programming the detector
Sultana N, et al.
American Journal of Analytical Chemistry, 04(1), 24-24 (2013)
Development and validation of an HPLC-UV method for the quantification of carbamazepine in rabbit plasma
Mowafy AH, et al.
Saudi Pharmaceutical Journal : SPJ : The Official Publication of the Saudi Pharmaceutical Society, 20(1), 29-34 (2012)
A rapid LC method for the identification and determination of CNS drugs in pharmaceutical formulations
Raggi.A.M, et al.
Journal of Pharmaceutical and Biomedical Analysis, 23(1), 161-167 (2000)
Pharmacology for the Primary Care Provider (2008)
U Amstutz et al.
Clinical pharmacology and therapeutics, 94(1), 142-149 (2013-04-17)
The occurrence of hypersensitivity reactions including rare but life-threatening Stevens-Johnson syndrome (SJS) and drug-induced hypersensitivity syndrome (HSS) limits the use of the anticonvulsant carbamazepine (CBZ). Human leukocyte antigen-B (HLA)-B 15:02 and HLA-A 31:01 have been identified as predictive genetic markers...

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