Function: | Urinary System Agents |
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Certification: | GMP |
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Solid |
Volatile: | Not Volatile |
Samples: |
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Items | Standard | Results |
Appearance(Ph.Eur.) | A white or yellowish-white powder | White powder |
Solubility(Ph.Eur.)(annual) | practically insoluble in water,soluble in ethanol (96 per cent) |
Complies |
Identification A.IR -spectrum(Ph.Eur.) A.IR -spectrum(USP) B.TLC(Ph.Eur.) B.UV Absorption(USP) C. Colour Reaction(Ph.Eur.) C.Precipitate reaction(USP) |
meets the requirement meets the requirement meets the requirement meets the requirement meets the requirement meets the requirement |
Complies Complies Complies Complies Complies Complies |
Specific optical rotation (Ph.Eur.) (USP) |
between -46° and -41° between -41° and -45° |
-43.3° -43.7° |
Loss on drying (Ph.Eur.) (USP) |
not more than 0.5% not more than 0.5% |
0.14% 0.12% |
Sulphated ash(Ph.Eur) | not more than 0.1% | 0.00% |
Related substances(Ph.Eur.) Impurity A Impurity F Impurity C Impurity D Impurity E Impurity I Any unspecified impurity Total |
not more than 0.2% not more than 0.3% not more than 0.2% not more than 0.15% not more than 0.3% not more than 0.5% not more than 0.10% not more than 0.7% |
ND ND ND ND ND ND Complies 0.07% |
Ordinary impurities(USP) | not more than 2.0% | Complies |
Free thiol compounds(Ph.Eur.) | a blue colour develops | Complies |
Free mercapto compounds(USP) | not more than 0.10ml | Complies |
Assay HPLC (Ph.Eur.) HPLC (USP) |
between 97.5 % and 102.0 % between 97.0 % and 103.0 % |
99.4% 100.1% |
Residual solvent(In-house) Methanol Tetrahydrofuran DMF |
not more than 3000ppm not more than 720ppm not more than 880ppm |
6ppm Less than LOD(0.4ppm) Less than LOD(43ppm) |
Particle size(In-house) | 95% not more than 20 microns | Complies |
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