China Manufacturer of Standard Heparin - Heparin Sodium (Porcine Source) – CSBIO manufacturers and suppliers

Manufacturer of Standard Heparin - Heparin Sodium (Porcine Source) – CSBIO

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Manufacturer of Standard Heparin - Heparin Sodium (Porcine Source) – CSBIO Detail:

INDICATIONS:
Prevention and treatment of thrombosis or thrombotic diseases (such as myocardial infarction, thrombophlebitis, pulmonary embolism and so on); also used in the treatments of disseminated intravascular coagulation (DIC) derived from all kinds of reasons; hemodialysis, extra-corporeal circulation, catheterization, microvascular surgery and anticoagulation treatment of some blood samples and instruments.

COMPANY ADVANTAGE
1.full product Chains:
We have the full product Chains, which starts from the Porcine mucosa with be processed to Crude heparin, Heparin sodium API that could be depolymerized to the API of Enoxaparin sodium, Dalteaprin sodum and Nadroparin calcium. We could control the product from the starting material and make sure the tracebility which is required by the regulated market. At present, we have our own crude heparin workshop, which could help us to not only control the cost bust also assure the quality of our product.
2.APIs’ Production Lines：
Facilities and Equipment Systems
There are dedicated production workshops respectively for Heparin API, Enoxaparin Sodium API and Dalteparin Sodium&Nadroparin Calcium API. These three workshops are all established and have their respective dedicated production equipments, HVAC system and purify water system, which could avoid the cross contamination.
3.Product qualification
For Heparin Sodium API, we have passed the followings audits, US-FDA, EDQM, CFDA, Germany/Korean and Turkey authority, CEP, EIR-LETTER, China and Germany GMP are available.
4.Production capacity is enough：Heparin Sodium API: 5 million mega
5.We basically estsabilshed GMP Six-system that can comply with the standard of EU GMP，US FDA CGMP and Chinese GMP which could make sure our product comply with the international quality systems.
6.The company is located in the Zhengding area of China (Hebei) Pilot Free Trade Zone, close to Shijiazhuang Airport and the high-speed railway station, with a good transportation location. On August 26, 2019, the State Council issued the “Overall Plan for China (Hebei) Pilot Free Trade Zone”. The Zhengding area focuses on the development of bio-medicine, international logistics and other industries. We will strive to build the company into a leading enterprise in the domestic heparin industry.
7.Main market: Italy, Russia, Ukraine, Belarus, Indian, Korean, Argentina, Turkey, Iran and so on.
8.Payment: TT in advance
Delivery details: within in 30days after confirmed the order by air
Flow Chart of Heparin Sodium
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Products Specification (EP)

TESTS	SPECIFICATIONS
Characters	White or almost white, hygroscopic powder.
Solubility	Freely soluble in water
Identification	A. It complies with the requirements described under Assay
	B. The ratio of anti-factor Xa activity to anti-factor IIa activity ranges between 0.9~1.1.
	C. ¹H-NMR Spectrum: comply with the Ph. Eur. specification of heparin about ¹H-NMR requirements.
	D. The principal peak in the chromatogram obtained with test solution is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution.
	E. It complies with the test for sodium.
Appearance of solution	The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate color.
pH	5.5 ~ 8.0
Nucleotide impurities	Absorbance at 260 nm: ≤0.15
Protein	≤0.5%
Related substances	A. Sum of dermatan sulfate and chondroitin sulfate: not more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution (e) (2.0 per cent); B. Any other impurity: no peak with an area greater than 0.01 times the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution (e) is detected (corresponding to a disregard limit of 0.02 per cent)
Nitrogen	1.5%~2.5%
Sodium content	10.5%~13.5%
Loss on drying	≤8.0%
Bacterial endotoxin	Less than 0.01 IU/IU of heparin
Potency	≥180 IU/mg

Products Specification (USP)

TESTS	SPECIFICATIONS
Characters	White or almost white, hygroscopic powder.
Solubility	Freely soluble in water
Identification	¹H-NMR Spectrum: No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges: 0.10–2.00, 2.10–3.20, and 5.70–8.00 ppm. No signals greater than 200% of the mean of the height of signals 1 and 2 are present in the 3.75–4.55 ppm for porcine heparin . Chromatographic: The retention time pf the major peak of the Sample solution corresponds to that of the Standard solution. Anti-factor Xa to anti-factor Ⅱa ratio: 0.9 – 1.1 Molecular weight: M is NMT 20%, M is between 15,000 Da and 19,000 Da, and the ratio of M to M is NLT 1.0. A solution of Heparin Sodium imparts an intense yellow color to a nonluminous flame.




Appearance of solution	The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate color.
pH	5.0 ~ 7.5
Nucleotide impurities	NMT 0.1% (w/w) is found.
Protein	NMT 0.1% (w/w) is found.
Related substances	Proceed as directed in Identification A. No features associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00 ppm. Proceed as directed in Identification B. No peaks corresponding to oversulfated chondroitin sulfate should be detected eluting after the heparin peak.
Loss on drying	≤5.0%
Bacterial endotoxin	It contains NMT 0.03 USP Endotoxin Units/USP Heparin Unit.
Potency	≥180 IU/mg

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