Trimethoprim (TMP) Pharma Grade

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