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Merck
CN

PHR9350

Supelco

Gliclazide EP Impurity B

certified reference material, TraceCERT®, Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

Synonym(s):

2-Nitroso-octahydrocyclopenta[c]pyrrole

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About This Item

Empirical Formula (Hill Notation):
C7H12N2O
CAS Number:
54786-86-6
Molecular Weight:
140.18
MDL number:
MFCD09753830
UNSPSC Code:
12352200

Key Documents

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grade

certified reference material
TraceCERT®

Quality Level

300

Agency

Not traceable to any primary pharmacopeia standard

API family

gliclazide

product line

TraceCERT®

shelf life

limited shelf life, expiry date on the label

manufacturer/tradename

Manufactured by: Sigma-Aldrich Production GmbH, Switzerland

technique(s)

HPLC: suitable

application(s)

pharmaceutical

format

neat

storage temp.

−20°C

SMILES string

N1(CC2C(C1)CCC2)N=O

InChI

1S/C7H12N2O/c10-8-9-4-6-2-1-3-7(6)5-9/h6-7H,1-5H2

InChI key

FSCBDDOKZIRLCN-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 in-house working standards.

Application

Gliclazide EP Impurity B may be used as a pharmaceutical reference standard for the determination of impurities in pharmaceutical formulations by chromatography 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.

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.

Legal Information

TraceCERT is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class Code

10 - Combustible liquids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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