HPLC 90% Purity Chondroitin Sulfate Sodium Extracted From Bovine Cartilages GMP Manufacturer
Jiaxing Hengjie Biopharmaceutical Co.,ltd. is a GMP Manufacturer of chondroitin sulfate sodium extracted from Bovine cartilages.
General Introduction of Bovine chondroitin Sulfate sodium 90% purity by HPLC:
Bovine Chondroitin Sulfate Sodium is the sodium form of Mucopolysaccharides extracted from bovine cartilages, it is usually with purity of about 90% tested by HPLC method on dry basis. It is of white to yellowish powder, extremely hygroscopic once dried.
The specification sheet of Bovine Chondroitin Sulfate Sodium by HPLC 90% :
Product: | Chondroitin Sulfate sodium | |||||||
Original | Bovine(Terrestrial) | Report Date | 2017/04/17 | |||||
Batch No.: | HS1704026 | Quantity: | 1000KGS | |||||
Net Weight: | 25KG/DRUM | Gross weight: | 27.5KG/DRUM | |||||
Manufacturing Date: | 2017/04/10 | Expiry Date: | 2019/04/09 | |||||
ITEMS | SPECIFICATIONS (TEST METHOD) | RESULT | ||||||
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 | ||||||||
Assay(ODB) | NLT90% (HPLC) | 91.6% | ||||||
Loss on drying | Less than12%(USP731) | 8.0% | ||||||
Nonespecific Dissaccharides | NMT10% | 7.2% | ||||||
Protein | NMT6.0%(USP38) | 4.9% | ||||||
Sulfate | <0.24%(USP221) | <0.24 | ||||||
Chloride | <0.5% (USP221) | <0.5% | ||||||
Heavy Metal | NMT20PPM (Method I USP231) | Pass | ||||||
PH (1%H2O solution) | 5.5-7.5(USP791) | 6.4 | ||||||
Specific Rotation | - 20°~ -30°(USP781S) | -22.5° | ||||||
Residue on Ignition | 20%-30%(dry base)(USP281) | 25.5% | ||||||
OrganicVolatile Residual(Ethanol) | NMT0.5% (USP467) | PASS | ||||||
Clarity (5%H2O solution) | <0.35@420nm | 0.22 | ||||||
Electrophoretic purity | NMT2.0%(USP726) | Pass | ||||||
Bulk Density | NLT 0.5g/ml | 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 | ||||||
Enterobacteria | Negative in 1 gram (USP2022) | Negative | ||||||
Particle size | 100% through 80 mesh | Pass | ||||||
Storage: 25kg/drum, keep in an airtight container, protected from light. |
The advantage of our Bovine Chondroitin Sulfate Sodium :
1. Produced in GMP Workshop, Mircroorganism is strictly controlled, no irradiation is needed.
2. All testing items fully tested by our own Laboratory. We have established an advanced laboratory within our factory, which is able to perform all the testing items listed above.
3. NSF-GMP Quality Mangement system. Our company is NSF-GMP qualified since 2012/
4. Drug Master File Available. The US DMF # of chondroitin sulfate is : 26474. The documentation is available in CTD Format.
5. HACCP: Our bovine chondroitin sulfate is HACCP verified.
6. Drug Manufacturing Lisence from China FDA. Our company has the Drug Manufacturing Lisence for chondroitin sulfate as API from China FDA.
We have professional sales Team who will serve you timely and efficiently.
1. Fluent English Writing and Speaking.
2. Fast response to your request, either by email or by Whatsapp, Skype.
3. Our sales people has Professional knowledge of chondroitin sulfate sodium with more than 5 years experience in chondroitin sulfate industry.
Sample and Payment Term :
1. Free sample of less than 150gram is available for testing upone request.
2. Payment term: We accept T/T payment, LC payment, and we can offer 30 days credit for regular customers, even longer credit is negotiable.
3. Lead Time: For order of less than 1000KG, we can arrange shipment within 7-10 days including CIQ time.
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