SR NO.

CHARACTERISTICS

TEST METHOD

REQUIREMENTS AS PER PHARMACPIA

TYPICAL RESULTS

1.

Description

Visual

White, translucent, soft unctuous, retaining these characters on storage & when melted& allowed to cool

without stirring; not more then slightly florescent by day light, even melted; odorless when rubbed on screen.

Complies

2.

Colour

IP 17/52

0.5 (Y)

0.2Y

3.

Odour

Organoleptic

Nil

Nil

4.

Color

USP 31

Passes

Passes

5.

Congealing Point

ASTM D938

50°C to 60°C

51°C

6.

Drop melting Point

ASTM D127/USP 31

57-60

58.5

7.

Acidity or Alkalinity

USP 31

Neutral

Complies

8.

Fixed oils, fats & resins

USP 31

No ppt or oily matters is produced

Passes

9.

Specific Gravity @ 25°C

USP 31

0.860 to 0.890

0.867

10.

Consistency @ 25°C

USP 31 / ASTM D937

180-200 dmm

185

11.

Residue on ignition

USP 31

Not more than 0.05%

0.02%

12.

Organic acids

USP 21

To pass

Passes

13.

Polycyclic Aromatic Hydrocarbons

BP 2008

To Pass

Passes

14.

Polynuclear Compounds

FDA 21 CFR 172.880

To Pass

Passes

15.

Kinematic Viscosity @ 99°C

ASTM D445

9 – 12.5

10.5