PRODUCT NAME

ALLOPURINOL

BATCH NO

20230312

ANALYSIS DATE

2023.03.12

REPORT DATE

2023.03.12

QUANTITY

505KG

STANDARD

USP 36

TEST

SPECIFICATIONS&LIMTIS

RESULTS

APPEARANCE

WHITE OR ALMOST WHITE POWDER

COMPLIES

IDENTIFICATION

CONFORM WITH IR SPECTRUM

COMPLIES

IMPURITY A NMT0.2

NOT DETECTED

IMPURITY B NMT0.2

NOT DETECTED

IMPURITY C NMT0.2

COMPLIES

IMPURITY D NMT0.2

NOT DETECTED

IMPURITY E NMT0.2

NOT DETECTED

IMPURITY F NMT0.2

NOT DETECTED

TOTAL IMPURITIES OTHER A,B AND C NMT0.3

COMPLIES

INDIVIDUAL UNKNOWN IMPURITIES NMT0.1

COMPLIES

LIMITED OF HYDRAZINE

NMT 10PPM

COMPLIES

SULPHATED ASH(%)

NMT 0.1

0.06%

LOSS ON DRYING(%)

NMT0.5

0.06%

HEAVY METAL

≤20ppm

〈20ppm

RESIDUE ON IGNITION

≤0.1%

0.05%

SINGLE IMPURITY

≤0.2%

0.03%

TOTAL IMPURITY

≤1.0%

0.04%

MICROBIOLOGICAL LIMIT

TOTAL BACTERIA≤1000/g

TOTAL NUMBER OF MOLDS AND YEASTS≤100/g

E.coli MAY NOT BE DETECTED.

320/g

20/g

E.coli WAS NOT DETECTED.

ASSAY(%)

98.0~102.0

99.09%

CONCLUSION

COMPLIES WITH USP36.