CPC 90% Assay Bovine Chondroitin Sulfate White Powder USP40 For Health Food Additive
As a professional manufacturer of chondroitin sulfate, we upgrade our quality standard of chondroitin sulfate to USP40 standards, which is the most latest USP quality standard for chondroitin.
The main purpose of USP40 standards 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.
Compared with previous version of USP monograph, Below are the changes in the USP40 monograph for chondroitin sulfate:
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.
Specification of chondroitin sulfate that is up to USP40 standard:
|Product:||Chondroitin Sulfate Sodium|
|Net Weight:||25KG/DRUM||Gross weight:||27.5KG/DRUM|
|Manufacturing Date:||2019/07/15||Expiry Date:||2021/07/14|
SPECIFICATIONS (TEST METHOD)
|Appearance||White to off-white powder||Pass|
|Identification||Infra Red Confirmed (USP197K).||Pass|
|Sodium reaction (USP191)||Positive|
|The chromatogram of the enzymatically digested sample solution as obtained in the test for the limit of nonspecific disaccharides shows three main peaks corresponding to △DI-4S, △DI-6S,△DI-OS in the enzymatically digested standard solution. By peak area response, △ DI-4S is the most abundant, followed by the △ DI-6S, with △ DI-OS being the least abundant of the three||Pass|
|Specific Rotation: Meet the requirements for optimal Rotation||Pass|
|Loss on drying||Less than12%(USP731)||8.6%|
|PH (1%H2O solution)||5.5-7.5(USP791)||6.3|
|Specific Rotation||- 20°~ -30°(USP781S)||-23.5°|
|Residue on Ignition||20%-30%(dry base)(USP281)||24.5%|
|OrganicVolatile Residual(Ethanol)||＜0.5% (USP467)||PASS|
|Clarity (5%H2O solution)||<0.35@420nm||0.21|
|Bulk Density||＞ 0.5g/ml||Pass|
|Total Bacteria Count||<1000CFU/g (USP2021)||Pass|
|Yeast & Mold||<100CFU/g (USP2021)||Pass|
|Staphylococcus Aureus||Negative (USP2022)||Negative|
|Enterobacteria||Negative in 1 gram (USP2022)||Negative|
|Particle size||100% through 80 mesh||Pass|
|Conform to USP40 standards|
|Storage: 25kg/drum, keep in an airtight container, protected from light.|
The function of Chondroitin sulfate sodium
1. Rehabilitate the attrited arthrosis cartilage,is a key structural component in cartilage and acts as a lubricant.
2. Enhance the immunity and improve osteoporosis.
3. Cure neuralgia, arthralgia and process the concrescence of wounds.
4. Promote the synthesis of mucopolysaccharides, advance the viscosity of synovia, and improve the metabolism of arthroidal cartilage.
5. Has some curative effect on rheumatoid arthritis and hepatitis.
6. Has some curative effect on melanoma, lung cancer and renal carcinoma.
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 October 22, 2014 and valid until October 21, 2019
2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Oct.11, 2018 and valid until October 11, 2021.
2012 April --Pass the FDA site inspection with zero inspectional observation
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 March 2, 2017 and valid until March 1, 2020.
2016 March---HALAL Verified. It was renewed on March 30, 2016 and valid until March 29, 2019.
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