Amorolfine hydrochloride 78613 38 4

Tests

Specifications

 Results

Characters

White to off-white crystalline powder with a characteristic sulfide-like order

Complies

Identification

IR:similar to Reference Standard

Complies

Appearance of solution

Clear and colorless

Complies

Specific Rotation

-127°to -132°

-131°

Loss on Drying

≤0.5%

0.06%

Sulphated Ash

≤0.2%

0.03%

Heavy metals

≤0.002%

Complies

pH

2.0 to 2.6

2.3

Related Compouds

1. 1.    Single Impurity ≤1.0%
2. 2.    Sum of Impurity≤2.0%

Undetected

Undetected

Assay(Anhydrous)

98.0% to 101.5%

100.2%