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PHR1739

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Mesalazine Impurity C

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
2-Aminophenol
Linear Formula:
H2NC6H4OH
CAS Number:
95-55-6
Molecular Weight:
109.13
Beilstein:
606075
EC Number:
202-431-1
MDL number:
MFCD00007690
PubChem Substance ID:
329823584
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001569

API family

mesalazine, mesalamine

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

170-175 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Nc1ccccc1O

InChI

1S/C6H7NO/c7-5-3-1-2-4-6(5)8/h1-4,8H,7H2

InChI key

CDAWCLOXVUBKRW-UHFFFAOYSA-N

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General description

Mesalazine Impurity C is a related compound of anti-inflammatory agent mesalazine. Mesalazine belongs to a group of drugs referred as aminosalicylates and is generally used in the treatment of inflammatory bowel disease.
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.

Application

Mesalazine Impurity C may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
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 LRAA7943 in the slot below. This is an example certificate only and may not be the lot that you receive.

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Pictograms

Exclamation markHealth hazard
GHS07,GHS08

Signal Word

Warning

Hazard Statements

H302 + H332 - H341

Hazard Classifications

Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Muta. 2

Storage Class Code

6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 2

Flash Point(F)

334.4 °F - closed cup

Flash Point(C)

168 °C - closed cup

Regulatory Information

危险化学品

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Mesalazine
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 6962-2066 (2019)
Determination of related substances in mesalazine by HPLC-electrochemical detection
Song DM and Yang YJ
Chinese Journal of Pharmaceuticals / Chung-kuo i yao kung yeh tsa chih, 38(6), 442-442 (2007)
Determination of Mesalamine related impurities from drug product by reversed phase validated UPLC method
Kanubhai TR, et al.
Journal of Chemistry, 8(1), 131-148 (2011)
Aminosalicylates in inflammatory bowel disease
Hanauer SB
Alimentary Pharmacology & Therapeutics, 20, 60-65 (2004)

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