Chemical Name

Type   II Collagen

CAS Number

9064-67-9

Molecular Formula

(C₆₅H₁₀₂N₁₈O₂₁)x

Compliance (Food / Pharmacopoeia / FCC / Feed)

Food

Brief   Introduction:

Type II collagen, the main structural protein   in articular cartilage, provides strength, elasticity, and cushioning to   joints, making it a key ingredient for supporting mobility, flexibility, and   long-term joint health.

Item

Standard

Analysis   Method

Appearance

White to   Off-white Powder

Visual

Odor   &Taste

Characteristic

Organoleptic

Protein

≥ 50%

GB 5009.5 /   USP

Total Collagen   Content

≥ 60%

In-house   Method

Type II Collagen

≥ 20%

In-house   Method

Other Natural Collagen,   Mainly Type I Collagen

Balance

In-house   Method

Chondroitin   Sulfate

≥ 27–30%

CPC Titration   / GB Method

Hyaluronic   Acid

≥ 7–10%

HPLC / USP   Reference

Moisture

≤ 8%

GB 5009.3

Ash Content

≤2%

Eur.Ph.   <2.4.16>

Heavy metals

Total Heavy   Metals

≤10 ppm

USP   <233>

Lead

≤1.0 ppm

USP   <233>

Arsenic

≤1.0 ppm

USP   <233>

Cadmium

≤1.0 ppm

USP   <233>

Mercury

≤0.1 ppm

USP   <233>

Microorganism

Total   plate count

≤1,000 cfu/g

USP <61>

Molds &   Yeasts

≤100 cfu/g

USP <61>

E. coli

Negative/10g

USP <62>

Salmonella

Negative/10g

USP <62>

Staphylococcus

Negative/10g

USP <62>

Storage   & Shelf Life

Package

25kg/drum

Shelf Life

The shelf life   for the product is 24 months from date of production. Use it as soon as   possible once it is opened.

Storage

Store in   unopened original package under clean and dry condition, away from sunlight.

Country of   origin of the product:  China

Origin   statement: available ☒

This product is a pure   material   ☐

This product is a compound   material  ☐

Animal origin

☐ bovine

Specific Source: /

☐   porcine

Specific Source：/

☐   ovine

Specific Source：/

☐ others:

Specific Source: /

Synthetic

☐

Starting material:

Origin:

Biotechnological processing

☐   Catalysis By Enzymes  

Name of Enzyme: /

Sources of Enzymes：/

☐   Fermentation

Source of Medium: /

Strain: /

Botanical Origin

Botanical Name:

/

Part:

/

Wild or Cultivated：

/

Country of Origin:

/

Solvent Used：

/

Nutritional Composition

☒Per   100g       ☐Per   Serving

☐Energy (KJ)  ☒Energy (Kcal)

0kcal

Fat (g)

0

Carbohydrates (g)

0

Protein (g)

0

Sodium (mg)

0

Remarks: Nutrition Data Are   Obtained By 3rd Party Lab; Tested on A Yearly Basis

YES

NO (Means Not

Contain)

The product does not contain or   consist of GMO

☐

☒

The product is not produced from GMO   or not contain ingredients produced from GMO (irrespective of whether there   is NDA or protein of GM origin in the final production)

☐

☒

This product is not produced by means   of GM microorganism including precursor substances, e.g., with GMOs or   Genetically Modified microorganisms processing aids (bacteria, yeast,).

☐

☒

This product is not produced with the   help of enzymes, which were obtained from GMOs

☐

☒

Does the product contain any   ingredients from animal?

If yes, are genetically modified   crops contained in the feed for the animal?

☐

☐

☒

☒

We confirm that this product complies   with regulations EC/18292003 and EC1830/2003 and keep non-GMO statement   available.

☒

☐

We have carefully reviewed this   product according to EU Regulation 1169/2011 and modifications and confirm   the following:

Direct incorporation as a base raw material or in   a derivative form (don’t forget the carriers, the additives, and the   processing aids)

CROSS CONTAMINATION

Presence on the production line

Presence on the production workshop

Presence on the production factory

Yes

(Precise nature)

No

Yes (precise the nature)

No

Yes (precise the nature)

No

Yes (precise the nature)

No

Cereals   containing gluten (1) and products thereof

N

N

N

N

Crustaceans   and products thereof

N

N

N

N

Eggs and   products thereof

N

N

N

N

Fish and   products thereof (2)

N

N

N

N

Peanuts and   products thereof

N

N

N

N

Soybeans and   products thereof (3)

N

N

N

N

Milk and   products thereof (including lactose) (4)

N

N

N

N

Nuts (5) or   products thereof

N

N

N

N

Celery and   products thereof

N

N

N

N

Mustard and   products thereof

N

N

N

N

Sesame seeds   and product thereof

N

N

N

N

Sulphur   dioxide and sulphites at concentrations of more than 10mg/kg or 10 mg/l   expressed as SO2

N

N

N

N

Lupines and   products thereof

N

N

N

N

Mollusc and   product thereof

N

N

N

N

1.       Cereals which contain gluten (i.e. wheat, rye, barley, oats, spelt,   kamut or their hybridised strains) except: wheat-based glucose syrups   including dextrose, wheat-based maltodextrins, glucose syrups based on   barley, cereals used for making distillates or ethyl alcohol of agricultural   origin for spirit drinks and other alcoholic beverages;

2.       Except: fish gelatine used as carrier for vitamin or carotenoid   preparations, fish gelatine or Isinglass used as fining agent in beer and   wine.

3.       Except fully refined soybean oil and fat, natural mixed tocopherols   (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate,   natural D-alpha tocopherol succinate from soybean sources; vegetable oils   derived phytosterols and phytosterol esters from soybean sources; plant   stanol ester produced from vegetable oil sterols from soybean sources.

4.       Except when used for making distillates or ethyl alcohol of   agricultural origin for spirit drinks and other alcoholic beverages,   lactitol.

5.     Almond (Amygdalus communis   L.) hazelnuts (Corylus avellana), walnut (Juglans regia), cashew (Anacardium   occidentale), pecan nuts (Carya illinaiesis), Brazil nut (Bertholletia   excelsa), pistachio nut (Pistacia vera), macadamia nut and Queensland nut   (Macadamia terniflora) and products thereof, except nuts used for making   distillates or ethyl alcohol of agricultural origin for spirit drinks and   other alcoholic beverages;

This product has not been treated with ionising   radiation

☐YES

☒NO, not treated

None of the raw materials we used for this product   have been treated with ionising radiation.

☐YES

☒NO, not   treated

We   confirm above non-Irradiation statement is available

☒YES

This product does not contain any nanomaterials as   defined in EU food legislation

☐YES

☒NO, does not contain

This product has not been made with nanotechnology

☐YES

☒NO, is not made with

nanotechnology

We   confirm above non-Nanomaterial statement is available

 ☒YES

For   this product following solvents are used during production process:

Solvent A:            max residual level: 

☒solvent used.

☐solvent not used

We   confirm solvent residual of this product complies with:

☒EP 7.0

☒USP   <476>

☒ICH   Q3C(R7)

☒Directive   2010/59/EU

☐NA

We   confirm Solvent residual statement is available

☒YES

This   product is of vegetable origin

☒YES     ☐NO

We   confirm pesticide residual of this product complies with:

☒EC 396/2005

☒EP   07/2008

☒USP<561>

☐N/A

Pesticide residual statement   available

☒YES

Cattle,   sheep, goats, and other animals naturally susceptible to infection with   transmissible spongiform encephalopathy (TSE) agents, or those susceptible to   infection through the oral route (excluding humans and non-human primates),   are defined as "BSE-relevant animal species." Pigs and birds,   however, are not naturally susceptible to infection via the oral route and,   therefore, are not considered TSE-relevant species. Similarly, dogs, rabbits,   and fish are also not classified as TSE-relevant animal species.

The product contains no   ingredients of ruminant origin and no materials derived from or exposed to   ruminants affected by or under quarantine for Transmitting Transmissible   Spongiform Encephalopathy (TSE) / Bovine Spongiform Encephalopathy (BSE).

☐YES

☒NO

☐NA

In the manufacturing of this   product, there is not any raw or source material and /or reagent used that is   of animal origin i.e., bovine, serum-albumin, enzymes, culture broths   including those used to prepare working or master cell tanks.

☐YES

☒NO

Equipment/systems/tools use for   processing or storage of the material do not come into contact at any time   with materials of animal origin (e.g., components of media filler used to   check such system).

☐YES

☒NO

The material is not purified by   using solvents, chromatographic media or buffers that contain components of   animal origin.

☐YES

☒NO

We confirm this product complies   with:

☒EU legislation 999/2001 &

☒EP general chapter 5.2.8

We confirm BSE/TSE statement is   available

☒YES   

Aflatoxin B1 <5ppb

Aflatoxins B1 + B2 + G1 + G2 <10ppb

Ochratoxin A <15ppb

☒YES

☐NO

☐NA

Melamine   Free

☒YES

Dioxins, Furans, Polychlorinated Biphenyls Free

☒YES

For polycyclic aromatic hydrocarbons, in cocoa   fiber, banana chips, food supplements and their preparations, dried herbs and   dried spices:

Maximum level of 10 µg/kg of benzo(a)pyrene

50 µg/kg for the sum of PAH4 (PAH4; benzo[a]pyrene,   chrysene, Benz[a]anthracene and benzo[b]fluoranthene) in food supplements

☒YES

☐NO

☐NA

We confirm this product complies   with NO.1881/2006 and NO.629/2008 and keep compliance   statement available

☒YES

We confirm that none of the products manufactured or   stored within our facility contain any prohormones, stimulants, steroids, or   other substances listed on the current WADA (World Anti-Doping Agency) list.

We hereby confirm that ethylene oxide (ETO),   2-chloroethanol, or any other chemical sterilizing agents are not used during   the manufacturing, storage, or transportation of our products.

We confirm Nitrates   of this product complies with EU No 1258/2011

☒YES

☐NO

☐NA

We confirm Mycotoxins / Aflatoxins of this   product complies with EU No 165/2010

☒YES

☐NO

☐NA

We confirm 3-MCPD of this product complies with EU No. 2020/1322

☒YES

☐NO

☐NA

We confirm Pyrrolizidine alkaloids of this product complies with Regulation (EU) 2020/2040

☒YES

☐NO

☐NA

Type   II Collagen

9064-67-9

≥20%

Active   ingredient

Total   Collagen

—

≥60%

Includes   Type II + other

Protein

—

≥50%

By   GB 5009.5 / USP

Other   Natural Collagen

—

Balance

Mainly   Type I

Appearance

White   to off-white powder

Odor

Characteristic   protein odor

pH   (1% solution)

5–7

Solubility

Soluble   in hot water; partially soluble in cold water

Molecular   Weight

~300–400   kDa (native); 2–6 kDa (hydrolyzed)

CAS   Number

9064-67-9