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Trimethoprim (INN) is a bacteriostatic antibiotic used mainly in the prophylaxis and treatment of urinary tract infections. It belongs to the class of chemotherapeutic agents known as dihydrofolate reductase inhibitors. Trimethoprim was formerly marketed by GlaxoSmithKline under trade names including Proloprim, Monotrim, and Triprim; but these trade names have been licensed to various generic pharmaceutical manufacturers.
Specification:
|
Test Item |
Analysis Specification |
Result |
|
Description |
White or yellowish white power |
white power |
|
Identification A Infrared Absorption B: Ultraviolet Absorption |
IR conforms to standard <197k> Absorptivities, calculated on the dried basis, differ by NMT 3.0%<197u> |
Complies
complies
|
|
Melting point |
190~203°C |
201.5~201.8°C |
|
Loss on drying |
≤0.5% |
0.1% |
|
Residue on ignition |
≤0.1% |
0.02% |
|
Chromatographic purity(HPLC) |
Individual impurity≤0.1% Total impurities≤0.2% |
0.08% 0.08% |
|
Residual solvents |
Methanol ≤3000 ppm DMSO ≤3000 ppm |
Complies Complies |
|
Assay(Dry Basis) |
98.5%~101.0% |
100.3% |
|
Conclusion |
The commodity meets the standard of USP 30. |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
