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Product Description

Compound lutein softgel

Size

10# Oval

Filling weight

500mg±5%

Shelf Life

3 Years

Color

 Opaque brown

Total Weight

740mg±10%

Composition

No.

Ingredients

Quantity

Active

Excipient

Test method

1

Lutein 20%, mg

120mg

Provide

Lutein,mg

NLT20

√

GB5009.248

2

Vitamin A( 1.7million IU/g, mg

2.4mg

Provide

Vitamin A,IU

3500±20%

√

GB5009.82

3

Natural Vitamin E,mg(1000IU/g)

10mg

Provide

d-a-tocopherol,IU

8±20%

√

GB5009.82

4

Zinc oxide,mg

8mg

Provide

Zinc,mg

5mg(100-125%)

√

GB5009.14

5

Fish oil 36/24 EE

20mg

√

SC/T3503-2000

6

Bilberry extract 25%,mg

1mg

√

UV

7

Blueberry extract 25%, mg

1mg

√

UV

8

Grape seed extract,mg

1mg

√

UV

9

Bees wax, mg

30mg±7.5%

√

GB1886.87

10

Soybean oil, mg

266.6mg±7.5%

√

GB1535

11

Lecithin,mg

25mg±7.5%

     √

    GB28401

12

Palm oil,mg

15 mg±7.5%

     √

    GB15680

13

Gelatin, mg

144mg±7.5%

√

GB 6783

14

Glycerin, mg

72mg±7.5%

√

GB 29950

15

Pure water, mg

24mg±7.5%

√

CHP 2015

16

Caramel,%

3.046% to gelatin

√

GB1886.84

Physical & Chemical Standard

Items

Specification

Test method

Disintegration, min

NMT 30

USP<2040>

Microorganism Standard

Total bacterial count, CFU/g

  NMT 3000

USP<2021>

Coliform, MPN/10g

  Negative/10g

USP<2021>

E.co,MPN/g

Negative/1g

USP<2022>

Mold and Yeast, CFU/g

NMT 50

 USP<2022>

Salmonella

  Negative/25g

USP<2022>

Staphylococcus aureus                   

  Negative/1g

 USP<2022>

Heavy Metal Standard

Lead, mg/kg

NMT 2.0

 GB 5009.12(USP)

Arsenic, mg/kg

NMT 1.0

 GB 5009.11(USP)

Mercury, mg/kg

NMT 0.1

 GB 5009.17(USP)

Cadmium,mg/kg

NMT1.0