武汉东康源科技有限公司

Product name

Enalapril Maleate

According to

EP7.0

Source

Workshop

Batch No.

Package

Fibre drum

Manufacturing date

2023.04.09

Package size

25kg/drum

Report date

2023.04.13

Quantity

275.6kg

Retest date

2026.04.08

Items

Specification

Results

Description

White or off-white crystalline powder

White crystalline powder

Sparingly soluble in water,freely soluble in

Methanol,practically insoluble in methylene

chloride.It dissolves in dilute solutions of

Alkali hydroxides.

Complies

Mp：143℃~145℃

143.0~143.5℃

Identification

IR Spectrum accordance with that of CRS

Complies

Appearance of solution

Clear and colourless

Complies

PH

2.4 to 2.9

2.51

Specific rotation

-48°~ -51°

-50.2°

Loss on drying

Not more than 1.0%

0.006%

Sulphated ash

Not more than 0.1%

0.05%

Heavy metals

Not more than 0.001%

＜0.001%

Related substance

Impurity A:not more than 1.0%

No detectable

Impurity B:not more than 0.3%

0.06%

Impurity C:not more than 0.3%

0.07%

Impurity D:not more than 0.3%

No detectable

Impurity E:not more than 0.3%

No detectable

Impurity H:not more than 0.3%

＜0.05%

Single impurity:not more than 0.10%

＜0.05%

Total impurities:not more than 1.0%

0.20%

Residual solvent

Acetone: not more than 5000ppm

No detectable

Ethanol :not more than 5000ppm

85ppm

Dichloromethane:not more than 600ppm

No detectable

Hexane：not more than 290ppm

No detectable

Assay(Calculated on the dried basis）

98.5%~1.1.5%

100.5%

Conclusion:Complies with EP7.0