Azeco Cosmeceuticals

1.2.7 Ingredient

1.2.7.1 Specification The specification of the active ingredient is shown in the table below. More information on the used methods are reported in the next pages.

Testing parameter

Unit

Limit

Analytical method

1

Azelaic acid content

%

min. 99.0

2

Dicarboxylic acids < C9

%

Max. 0.5

GC (see the method reported in the paragraph 1.1.8.2)

3

Dicarboxylic acids > C9

%

Max. 0.5

4

Monocarboxylic acids

%

Max. 0.25

5

Water content

%

Max. 0.5

Karl Fisher (see the method reported in the paragraph 1.1.8.3)

6

Acid Value

mg KOH/g

590 - 605

(see the method reported in the paragraph 1.1.8.4)

7

Melting Point

°C

105 - 110

(see the method reported in the paragraph 1.1.8.5)

8

Colour

Apha

100

Gardner (see the method reported in the paragraph 1.1.8.6)

9

Residual Solvents***

ppm

Max. 7

GC (see the method reported in the paragraph 1.1.8.7)

10 Heavy Metals

ppm

Hg

ppm

1

Ni

ppm

1

ICP – AES (see the method reported in the paragraph 1.1.8.8)

Pb

ppm

1

Cd

ppm

0,2

*** 2,3,4-trimethylpentane (CAS 565-75-3)

ppm

<2

GC (see the method reported in the paragraph 1.1.8.7)

*** 2,3-dimethylexane (CAS 584-94-1)

ppm

<5

Aerobic mesophylic micro-organism count

CFU/mL

100

(see the method reported in the paragraph 1.1.8.9)

1.3 KOSHER and HALAL status of Azepur99® Azepur99® is made starting from Kosher and Halal certified raw materials (vegetable oil) and other reagents in compliance with these standards. It is then in compliance with both the standards. It can be assured that: 1. This product is from a synthetic manufacturing process fully based on raw materials of vegetable origin. 2. It does not contain any ingredient of animal origin and ingredients of animal origin have not been used in the manufacturing process. 3. The product does not contain ethanol (alcohol) and ethanol has not been used in the manufacturing process. 4. The equipment used in the manufacturing of this product does not get in contact with materials of animal origin or ethanol.

Mussenberg 1 • 6049 GZ Roermond • The Netherlands

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