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PHR1743

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3-Aminobenzoic acid

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
3-Aminobenzoic acid
Linear Formula:
H2NC6H4CO2H
CAS Number:
99-05-8
Molecular Weight:
137.14
Beilstein:
471603
EC Number:
202-724-4
MDL number:
MFCD00007795
PubChem Substance ID:
329823588
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

API family

aminobenzoic acid

CofA

current certificate can be downloaded

packaging

pkg of 200 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

178-180 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Nc1cccc(c1)C(O)=O

InChI

1S/C7H7NO2/c8-6-3-1-2-5(4-6)7(9)10/h1-4H,8H2,(H,9,10)

InChI key

XFDUHJPVQKIXHO-UHFFFAOYSA-N

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General description

3-Aminobenzoic acid, popularly known as Mesalazine Impurity E, is a related compound of anti-inflammatory agent Mesalazine. Mesalazine belongs to a group of drugs referred to 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

3-Aminobenzoic acid 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 LRAC4014 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Flash Point(F)

302.0 °F

Flash Point(C)

150 °C

Certificates of Analysis (COA)

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Mesalazine
European Pharmacopoeia Commission and European Directorate for the Quality of Medicines & Healthcare
European pharmacopoeia, 6962-2066 (2019)
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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