Business Type:Trader
Country/Region:Turkey
Ddu Verified
HOT Rank
Nazer Medical Supplies
We are professional supplier of Medical Personal Protective Equipments.
Business Type:Trader
Country/Region:Turkey
Ddu Verified
HOT Rank
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 |