Trimethoprim Trimethoprim Micronized TMP
API (原料药)
Product Name: Trimethoprim (TMP) 甲氧苄啶 Powder or Micronized
Cas: 738-70-5
Specification: BP EP USP
Documents: COS, GMP. EDMF, FDA, COFEPRIS, WHO, TGA
Packing: 25kg/drum
PRODUCT |
TRIMETHOPRIM MICRON |
PHARMACOPOLEIA |
BP2017 |
BATCH NO. |
201703320 |
GROSS WEIGHT |
29.5Kg/Drum |
BATCH QUANTITY |
500Kg |
NET WEIGHT |
25Kg/Drum |
MANUFACTURE DATE |
MAR.10,2017 |
EXPIRY DATE |
FEB,2022 |
ANALYSIS DATE |
MAR.10,2017 |
RELEASE DATE |
MAR.11,2017 |
TEST ITEM [Characters] Appearance Solubility
Particle Size [Identification] A:Melting point B:specific absorbance C:IR-spectrum D:chemical reaction Appearance of solution
[Related substances] HPLC method A: impurity F any impurity single total impurities HPLC method B: any impurity single total impurities Heavy metals Residul Methanol Residul DMSO Residul Acetic acid GC impurity K(aniline) Loss on drying Sulphated ash Assay |
STANDARDS REQUIRED
White or yellowish-white powder very slightly soluble in water, slightly soluble in alcohol. 90% pass 45micron
199—203℃ max.287nm:240-250 Complies with reference spectrum green fluorescence at 365nm not more intensely colored than reference solution BY7
≤0.1% ≤0.1% ≤0.2%
≤0.1% ≤0.2% ≤20PPM ≤3000PPM ≤5000PPM ≤5000PPM ≤5PPM ≤1.0 ≤0.1% 98.5—101.0% |
TEST RESULTS
White-yellowish-white powder very slightly soluble in water, slightly soluble in alcohol 90% pass 45micron
201.5—202.0℃ 246 Complies with reference spectrum green fluorescence at 365nm not more intensely colored than reference solution BY7
0.073% <0.1% <0.2%
<0.1% <0.2% <20PPM below detection limited below detection limited below detection limited below detection limited 0.2% 0.05% 99.8% |
|
Results:The commodity meets the standard of BP2017 |
PRODUCT |
TRIMETHOPRIM MICRON |
PHARMACOPOLEIA |
BP2017 |
BATCH NO. |
201603320 |
GROSS WEIGHT |
29.5Kg/Drum |
BATCH QUANTITY |
500Kg |
NET WEIGHT |
25Kg/Drum |
MANUFACTURE DATE |
MAR.10,2017 |
EXPIRY DATE |
FEB,2022 |
ANALYSIS DATE |
MAR.10,2017 |
RELEASE DATE |
MAR.11,2017 |
TEST ITEM [Characters] Appearance Solubility
Particle Size [Identification] A:Melting point B:specific absorbance C:IR-spectrum D:chemical reaction Appearance of solution
[Related substances] HPLC method A: impurity F any impurity single total impurities HPLC method B: any impurity single total impurities Heavy metals Residul Methanol Residul DMSO Residul Acetic acid GC impurity K(aniline) Loss on drying Sulphated ash Assay |
STANDARDS REQUIRED
White or yellowish-white powder very slightly soluble in water, slightly soluble in alcohol. 90% pass 45micron
199—203℃ max.287nm:240-250 Complies with reference spectrum green fluorescence at 365nm not more intensely colored than reference solution BY7
≤0.1% ≤0.1% ≤0.2%
≤0.1% ≤0.2% ≤20PPM ≤3000PPM ≤5000PPM ≤5000PPM ≤5PPM ≤1.0 ≤0.1% 98.5—101.0% |
TEST RESULTS
White-yellowish-white powder very slightly soluble in water, slightly soluble in alcohol 90% pass 45micron
201.5—202.0℃ 246 Complies with reference spectrum green fluorescence at 365nm not more intensely colored than reference solution BY7
0.073% <0.1% <0.2%
<0.1% <0.2% <20PPM below detection limited below detection limited below detection limited below detection limited 0.2% 0.05% 99.8% |
|
Results:The commodity meets the standard of BP2017 |
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