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Fish Oil Softgel

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Fish Oil Softgel

  • Taxonomy:End Products

  • Click times:
  • Date of release:2020/03/18
  • Specifications:
  • Type:
  • inquiry
  • introduce

Product Specification

1.   General Specification

 

No.

Fields

Specification

1.1

Dosage form

Soft capsule

1.2

Shape

Oval

1.3

Physical appearance

Clear   transparent shell containing light yellow liquid

1.4

Average fill weight

1000mg

1.5

Average total weight

1250mg

1.6

Uniformity of mass

±7.5%

1.7

Disintegration

NMT. 30 minutes

1.8

Storage conditions

In a well closed container complied with food hygiene requirements, at

10 – 25°C and 35% - 65% R.H.

1.9

Shelf Life

2   years from date of manufacture

 

2.   Master Formulation

 

No.

Active Ingredient

Actual input per   capsule

Control method

2.1

Fish oil (50/20,EE)

1000mg

QBI

 

No.

Capsule shell

Actual input per   capsule

Control method

2.2

Gelatin(Bovine skin)

164mg

QBI

2.3

Glycerol

65.5mg

QBI

2.4

Purified water

20.5mg

QBI

 

3.   Microbiological Limits

 

No.

Item

Specification   limit

Method

3.1

Total Aerobic Microbial Count (TAMC)

1000CFU/g

GB 4789.2

3.2

Total Yeast and Mould Count (TYMC)

50 CFU/g

GB 4789.15

3.3

Coli Form Group

0.3 CFU/g

GB 4789.3

3.4

Salmonella

Not detected/25g

GB 4789.4

 

4.   Heavy Metals

 

No.

Item

Release   limit

Method

4.1

Lead(Pb)

3.0mg/kg

GB 5009.12

4.2

Arsenic(As)

. 1.0mg/kg

GB 5009.11

4.3

Mercury(Hg)

0.3mg/kg

GB 5009.17

(1) QBI: Quantity buy input.


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