Product : Nandrolone Decanoate BP

Analysis As Per

BP

Specification No.

FP-009

Sr. No.

Test

Specification

1.              

Description

A white to creamy white, crystalline powder; odour, faint and characteristic.

2.              

Solubility

Practically insoluble in water; freely soluble in chloroform, in ethanol (96%), in ether, in fixed oils and in esters.

3.              

Identification

a)      The infrared absorption spectrum is concordant with the reference spectrum of nandrolone decanoate

b)      Carry out the method for thin-layer chromatography using a silica gel F254 precoated plate the surface of which has been modified by chemically bonded octadecylsilyl groups (Whatman KC 18F plates are suitable) and a mixture of 60 vol. of propan-2-ol, 40 vol. of acetonitrile and 20 vol.of water as the mobile phase. Apply separately to the plate 5 µl of each of three solutions in chloroform containing (1) 0.5% w/v of the substance being examined, (2) 0.5% w/v of nandrolone decanoate BPCRS and (3) equal volumes of solutions (1) and (2). After removal of the plate, allow it to dry in air until the solvent has evaporated and heat at 100° for 10 minutes. Allow to cool and examine under ultraviolet light (254 nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The principal spot in the chromatogram obtained with solution (3) appears as a single, compact spot.

c)      Melting point, about 35° C

4.              

Specific Optical Rotation

In a 2% w/v solution in 1,4-dioxan, +32° to +36°, calculated with reference to the dried substance.

5.              

Related Substances

Carry out the method for thin-layer chromatography using silica gel GF254 as the coating substance and a mixture of 70 volumes of heptane and 30 volumes of acetone as the mobile phase. Apply separately to the plate 5 µl of each of three solutions in chloroform containing (1) 1.0% w/v of the substance being examined, (2) 0.0050% w/v of the substance being examined and (3) 0.010% w/v of nandrolone BPCRS. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). In the chromatogram obtained with solution (1) any spot corresponding to nandrolone is not more intense than the spot in the chromatogram obtained with solution (3) and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (2).

6.              

Loss on Drying

Not more than 0.5 %

7.              

Sulphated Ash

Not more than 0.1 %

8.              

Assay

97.0 % to 103 % calculated on dry basis