Product

Raw material supplier

CLA Carnitine Soft Capsule

CLA Carnitine Soft Capsule

PRODUCT NAME                   

CLA Carnitine Soft Capsule                  

1. General Specification

No.

Fields

Specification

1.1

Dosage form

Soft capsule

1.2

Size/Shape

26 minim oblong

1.3

Physical appearance

Pending shell contains light yellow oily suspension.

1.4

Average fill weight

1350mg±7.5%

1.5

Average shell weight

550mg±7.5%

1.6

Average total weight

1900mg±7.5%

1.7

Uniformity of mass

NMT.2>7.5% &none>15%

1.8

Disintegration

Not more than 30 minutes.

1.9

Storage conditions

In a well closed container complied with food hygiene requirements, at 10 - 25°C and 35% - 65% R.H.

1.10

Transportation

Don’t mix or transport with toxic, hazardous, contaminative materials. Protect from impact, rain, sun and contaminations.

1.11

Shelf Life1

3 years from date of manufacture

2. Master Formulation

No.

Active Ingredient

Label claim

/capsule

Actual input

/capsule

Release

limit

2.1

L-Carnitine fumarate

 

200.0mg

 

Equiv. Carnitine

116.00

 

90%-110%

2.2

CLA 80%EE

_

800.0mg

 

Equiv. CLA

640.0mg

 

90%-110%

 

No.

Excipient

Actual input/capsule

2.3

Sunflower Oil

269.0mg

2.4

Beeswax

54.0mg

2.5

Lecithin

27.0mg

 

No.

Capsule shell

Quantity/capsule

2.6

Gelatin (with 12% water)

Pending

2.7

Glycerol

Pending

2.8

Colorant

Pending

2.9

Puridied-water

Pending

 

3. Microbial Release Limits

No.

Item

Release limit

3.1

Total viable aerobic count (TVAC)

NMT. 1 x 104CFU/g

3.2

Yeast and Mould Count

NMT. 1 x 102CFU/g

3.3

Enterobacteria

NMT. 1 x 102CFU/g

3.4

Salmonellae

Not detected/10g

3.5

Escherichia coli

Not detected/g

4. Purity Release Limits

No.

Item

Release limit

4.1

Heavy metals

NMT. 20ppm