Product Name

Loperamide Hydrochloride

Batch No

20220820

CAS NO.

34552-83-5

Manufacture Date

Aug.20,2022

Standard

USP40

Expiration Date

  Aug.19,2027

Test

Specification

Results

Appearance

White or almost white powder

white powder

Solubility

Freely soluble in methanol, and in chloroform.

Complies

Identication

IR

UV

A.The IR absorption Spectrum of the test specimen,exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding loperamide hydrochloride reference standard(working standard)

B. the UV absorption spectrum between 250 and 300 nm of this solution exhibits maxima and minima at the same wavelengths .

Complies

Complies

Loss on drying

≤0.50%

0.2%

Residue on ignition

≤0.20%

0.069%

Heavy Metal

≤20PPM

Complies

Chromatographic purity by TLC

No Secondary spot are observed

Complies

Chloride content

Between 13.52% and 14.20%

14.08%

Assay(on dried basis)

98.0-102%

99.84%

Conclusion : The product Conforms to USP40 Specifications