Mesalazine EP Impurity R

About Mesalazine EP Impurity R

Mesalazine EP Impurity R is a pharmacopeial impurity of Mesalazine carrying the CAS registry number 85-38-1. With the molecular formula C7H5NO5, it has a molar mass of 183.12 g/mol. The IUPAC name is 2-hydroxy-3-nitrobenzoic acid. Common synonyms include Mesalamine EP Impurity R and Mesalazine Impurity R.

The product is provided as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. The GHS classification uses the signal word “Warning”, so appropriate gloves, eye protection and ventilation are recommended.

As a characterised impurity of Mesalazine, it is used for analytical method development, method validation (AMV) and routine quality-control testing, and it supports ANDA and DMF regulatory filings. Buyers come mainly from pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Mesalazine

View every impurity, metabolite and intermediate we list for Mesalazine.

Mesalazine impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Mesalazine EP Impurity R
Catalogue No.	VQ-023074
CAS Number	85-38-1
IUPAC name	2-hydroxy-3-nitrobenzoic acid
Molecular formula	C₇H₅NO₅
Molecular weight	183.12 g/mol
Exact mass	183.0168
Grade	Reference Standard
HSN code	38229090
InChIKey	WWWFHFGUOIQNJC-UHFFFAOYSA-N
SMILES	C1=CC(=C(C(=C1)[N+](=O)[O-])O)C(=O)O
PubChem CID	6807

Physical properties
Physical form	Solid
LogP (XLogP3)	1.4
H-bond donors / acceptors	2 / 5
TPSA	103 Å²
Synonyms	Mesalamine EP Impurity R, Mesalazine Impurity R, Mesalazine - Impurity R, Mesalamine impurity R, 3-Nitrosalicylic acid, Salicylic acid, 3-nitro-, Benzoic acid, 2-hydroxy-3-nitro-, Salicylic acid, 3-nitro, 2-hydroxy-3-nitro-benzoic acid, 3-Nitro-salicylsaure, 3-Nitrosalicylicacid, 3-nitrosalicyclic acid

Safety & hazard information (GHS)

Harmful / irritant

Signal word: Warning

Hazard statements

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation

Precautionary statements: P261, P264, P264 + P265, P271, P280, P302 + P352, P304 + P340, P305 + P351 + P338, P319, P321, P332 + P317, P337 + P317, P362 + P364, P403 + P233, P405, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Mesalazine EP Impurity R?

The CAS Registry Number of Mesalazine EP Impurity R is 85-38-1. It is also known as Mesalamine EP Impurity R, Mesalazine Impurity R, Mesalazine - Impurity R.

What is the molecular formula and molecular weight of Mesalazine EP Impurity R?

Mesalazine EP Impurity R has the molecular formula C7H5NO5 and a molecular weight of 183.12 g/mol. Its IUPAC name is 2-hydroxy-3-nitrobenzoic acid.

What is Mesalazine EP Impurity R used for?

Mesalazine EP Impurity R is supplied as a characterised reference material related to Mesalazine. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Mesalazine EP Impurity R can I order?

We supply Mesalazine EP Impurity R in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Mesalazine EP Impurity R?

Yes. Every lot of Mesalazine EP Impurity R is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Mesalazine EP Impurity R be shipped internationally?

Yes. Mesalazine EP Impurity R is classified as hazardous, so it is packed in UN-approved packaging and shipped as dangerous goods under IATA/IMDG rules. We export worldwide on EXW, FOB, CIF and DAP terms.