Mesalamine, USP

  • Purchase Qty: 1
  • Unit: Bag(s)
  • Fob Unit Price: US $200
  • Production Capacity:10000kg
  • Payment Terms:T/T , Money Gram
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Nazer Medical Supplies

Business Type:Trader

Country/Region:Turkey

Ddu Verified

HOT Rank

6/10

Product Information

  • Chemical Formula:C7H7NO3
  • Molecular Weight:C7H7NO3
  • Assay:80.5
  • Pharmacopeia:CP
  • Package Type:special disguised package Application
  • Shelf Life:18 months
  • Storage:Sealed

Description

Description   

Mesalamine, USP is used primarily as an anti-inflammatory drug in the treatment of ulcerative colitis. All Spectrum Chemical USP grade products are manufactured, packaged, and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.

Synonyms:

m-Aminosalicylic Acid ; 2-Hydroxy-5-aminobenzoic Acid ; Mesalamine;

                           

Specifications  Back to Top

                                                     
Test Specification

Min Max
ASSAY (DRIED BASIS) 98.5 101.5 %
CLARITY OF SOLUTION CLEAR
pH (1 in 40 suspensions) 3.5 4.5
LOSS ON DRYING
0.5 %
RESIDUE ON IGNITION
0.2 %
CHLORIDE
0.1  %
SULFATE
0.2 %
HYDROGEN SULFIDE AND[nSULFUR DIOXIDE TEST PAPER NOT DECOLORIZED
Content of 3-Aminosalicylic Acid and other Related Impurities .
3-AMINOSALICYLIC ACID
0.2 %
ANY OTHER IMPURITY
0.2 %
TOTAL IMPURITIES
1.0 %
Content of Aniline, 2-Aminophenol and 4-Aminophenol .
ANILINE
0.0005 %
2-AMINOPHENOL
0.02 %
4-AMINOPHENOL
0.02 %
ELEMENTAL IMPURITIES AS REPORTED
IDENTIFICATION A (FTIR) SPECTRUM MATCHES REFERENCE
IDENTIFICATION  (B) RETENTION TIME CORRESPONDS TO STANDARD
EXPIRATION DATE

DATE OF MANUFACTURE

APPEARANCE

RESIDUAL SOLVENTS AS REPORTED
CLASS 3 (solvent) / ACETONE .
MONOGRAPH EDITION


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