Product Name

Praziquantel

Batch No.

20220309

Batch Quantity

100KG

Net Weight

25KG/drum

MFG. Date

Mar.09，2022

Exp. Date

Mar.08，2024

Analysis Date

Mar.10，2022

Report Date

Mar.10，2022

Pharmacopoeial Standard

USP32

ITEMS

SPECIFICATIONS

RESULTS

Characters

White or practically white crystalline powder

complies

Solubility

Very slight soluble in water，freely soluble in alcohol and in chloroform

complies

Identification

IR：Corresponding to Praziquantel CRS

Positive

Melting Range

136℃~142℃

138.6℃~140.2℃

Heavy metals

Not more than 0.002%

＜0.002%

Phosphate

Not more than 0.005%

＜0.05%

Loss on drying

Not more than 0.5%

0.12%

Residue on ignition

Not more than 0.1%

0.03%

Related Substances

Relate compound A：not more than 0.2%

Relate compound B：not more than 0.2%

Relate compound C：not more than 0.2%

A：0.05%

B：0.08%

C：Not detectable

Assay

98.5%~101.0% （dried basis）

99.80%

Residual Solvents

Limit of chloroform：NMT 60ppm

Limit of acetone:：NMT 500ppm

NMT 60ppm

NMT 500ppm

Conclusion

Conform with USP32