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| Place of Origin | CHINA |
| Brand Name | HS |
| Certification | NSF-GMP; ISO; Halal certificate |
| Model Number | 90% |
USP43 Bovine Chondroitin Sulfate White Powder 90% Purity With DMF Files
What are the changes compare USP43 and previous version of USP monograph?
Compared with previous version of USP monograph, Below are the changes in the USP43 monograph for chondroitin sulfate:
1. Identification:
Add : Dissacharides Compostion: △ DI-4S is the most abundant, followed by the △ DI-6S, with △ DI-OS being the least abundant of the three.
2. Loss on Drying:
Change from "Max 10%" to "Max 12%"
3. Add : Limit Nonespecific Dissacharides : No more than 10%.
The main purpose of the above changes is to identify the economically motivated adulterated chondroitin sulfate. Both Dissacharides composition testing and the nonespecific dissacharides involve a testing method called Enzymatic HPLC. This method will easily indentify the adulterant in the chondroitin sulfate.
Bovine chondroitin sulfate sodium is a type of Mucopolysaccharides extracted from bovine cartialges, with 90% purity tested by CPC titration method. The bovine cartilages used for the production of chondroitin sulfate sodium are from health animals used for the human consumption. The cartilages are free of BSE/TSE, and Veterinary health certificates are available for each shipment.
Chondroitin is one of the primary building blocks of cartilage, and it helps promote the synthesis of other cartilage compounds.
Increasing the availability of these compounds helps to reduce cartilage breakdown. It also helps cartilage resist compression, which improves joint mobility and flexibility.
We got DMF No. of Chondroitin Sulfate received from USFDA: 26474 in 2012 December.
The specification of bovine chondroitin sulfate sodium 90% by CPC Titration:
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ITEMS |
SPECIFICATIONS (TEST METHOD) |
RESULT |
| Appearance | White to off-white powder | Pass |
| Identification | Infra Red Confirmed (USP197K) | Pass |
| Sodium reaction (USP191) | Positive | |
| Assay(ODB) | NLT90% (CPC) | 92.4% |
| Loss on drying | Less than12%(USP731) | 8.8% |
| Protein | NMT6.0%(USP39) | 5.4% |
| Heavy Metal | NMT20PPM (MethodIIUSP231) | Pass |
| PH (1%H2O solution) | 5.5-7.5(USP791) | 6.2 |
| Chloride | NMT0.5%(USP221) | Pass |
| Sulfates | NMT0.24%(USP221) | Pass |
| Specific Rotation | - 20°~ -30°(USP781S) | -25.1° |
| Residue on Ignition | 20%-30%(USP281) | 23.5% |
| Clarity (5%H2O solution) | <0.35@420nm | 0.17 |
| Electrophoretic purity | NMT2.0%(USP726) | Pass |
| Total Bacteria Count | <1000CFU/g (USP2021) | Pass |
| Yeast & Mold | <100CFU/g (USP2021) | Pass |
| Salmonella | Negative (USP2022) | Negative |
| E.Coli | Negative (USP2022) | Negative |
| Staphylococcus Aureus | Negative (USP2022) | Negative |
| Particle size | 100% through 80 mesh | Pass |
The Function of chondroitin sulfate sodium
1. Skin Health Support: some research indicates that chondroitin sulfate supplements can help to manage the discomfort of chronic s kin conditions this study involved regimens lasting between two and three months.
2. Bone Health Support: chondroitin sulfate may help to manage the discomfort caused by narrowing spaces between bones this use is often combined with glucoseamine hydrochloride.
3. Bladder Function Support:some preparations of chondroitin sulfate an help to maintain healthy functions of the bladder.
4. Joint Health And Function: oral supplements of chondroitin sulfate can help to manage joint discomfort especially in the knees or hand.
The Manufacturing Production Flow Chart of bovine chondroitin sulfate:
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Bovine Cartilages |
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Pre-treatment(cartilages selecting and washing) |
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Boiling ( add NACL,boil for 5 hours at the temperature of 90℃) |
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Enzymolysis (add pancreatin, add NAOH to adjust the PH value to 8.5-9.0, boil for 6 hours at the temperature of 48℃-50℃ |
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Flitration |
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First sedimentation(add ethanol to dissolve out the crude chondroitin sulfate) |
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Hydrolysis (add water and NACL,add NAOH to adjust PH value to about 9.0. Adjust temperature to 48℃-50℃ |
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Flitration |
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Second sedimentation(add ethanol to dissolve out purified chondroitin sulfate |
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Dehydration (add ethanol to dehydrate the water out of chondroitin sulfate |
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Centrifugation (get rid of ethanol) |
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Drying |
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Milling and Sifting |
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Blending (No other materials are added, just mixing) |
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Packing and testing |
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Chondroitin sulfate in 25KGS/drum |
The Quality Management System in our company.
Following is the quality management system of our company, according to the time:
2008-- A GMP workshop (300,000 clean class) was built and put into service. It was upgraded to 100,000 clean class in 2011
2010 May -- Received the Drug Manufacturing License issued by the State FDA. It was renewed on Sep 2, 2019 and valid until Sep 1, 2024
2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Aug 22, 2023 and valid until October 11, 2024.
2012 April --Pass the FDA site inspection with zero inspectional observation
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2012August --Received the NSF-GMP certificate and listed as a GMP manufacturer of dietary supplements on NSF website and renew the certificate every year.
2012 September--- Register our plant at EU Commission as an animal by products manufacture, the approval number is 3300DZ0091 .
2012 December –DMF NO. of Chondroitin Sulfate received from USFDA: 26474.
2014 March--- MSC Verified for Shark Chondroitin and Shark Cartilage Powder. It was renewed on Feb 28, 2023 and valid until Feb 27, 2026.
2016 March---HALAL Verified. It was renewed on March 29, 2023 and valid until March 28, 2025.
2018 March---Obtain Certificate of Recording for Export Food Manufacturing Enterprises and valid until March 2023
2019 June--- Obtain API registration number Y20190000453
Q1. What is your terms of packing?
A: Generally, we pack our goods in neutral paper drum. If you have legally registered patent,
we can pack the goods in your branded boxes after getting your authorization letters.
Q2. What is your terms of payment?
A: T/T 30% as deposit, and 70% before delivery. We'll show you the photos of the products and packages
before you pay the balance.
Q3. What is your terms of delivery?
A: EXW, FOB, CFR, CIF, DDU.
Q4. How about your delivery time?
A: Generally, it will take 5 to 10 days after receiving your advance payment. The specific delivery time depends
on the items and the quantity of your order.
Q5. Can you produce according to the samples?
A: Yes, we can produce by your samples or technical datas. We have the proffesional R&D team.
The photo of our workshop.
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