GMP Sodium Bicarbonate Pd Solution and Injection Buffer Grade Grade

Product Description

Sodium Bicarbonate BP USP Grade

Product Description

 

Sodium Bicarbonate or a mixture of Sodium bicarbonate and lactate is currently a relatively ideal buffer. It is more in line with human physiology, has better biocompatibility, can avoid the adverse reactions caused by lactate as a buffer, and causes less infusion pain.
In the past, due to the precipitation problems of calcium carbonate or magnesium carbonate, bicarbonate failed to be used as a buffer for peritoneal dialysis fluid. However, by using the double-chamber bag system and mixing the Sodium bicarbonate in the buffer chamber with the divalent cations in the glucose chamber at the time of use, this problem has been solved. 
Sodium bicarbonate is also used as antacid for the treatment of metabolic acidosis and alkalization of urine. It can also be used as antacid to treat symptoms caused by excessive gastric acid.
 

The Advantages of Product

 

Excellent quality
Strict quality standard and low impurity limit. The particles are full and smooth, and the particle size distribution is uniform.
Advanced equipment
With the adoption of new patented equipment, fully automated production and operation are realized, with high efficiency, stable output and distinct product particles.
Complete categories
Overcoming the technical barrier of large granular sodium bicarbonate, A P I, reagents and phar maceutical excipients can be supplied at three levels, which are suitable for oral administration, injection, hemodialysis and other fields.
 

Detailed Photos

 

Product Parameters

 

Characteristic	Unit	EP	Enterprise Quality Standard
Description/ Appearance			This product is white or white-like crystalline powder. It is white crystalline powder; Odorless. It gradually becomes sodium bicarbonate when left standing in damp air, and the alkalinity of the aqueous solution increases when left dry or heated in solution for a little longer, either by shaking or by heating.
Solubility		Soluble in water, practically insoluble in ethanol(96%)	Soluble in water, insoluble in ethanol
Sodium salt		Comply with the regulation	Comply with the regulation
Bicarbonate		Positive reaction	Positive reaction
Basicity		pH≤8.6	pH≤8.6
Clarity of solution		Should be clear and colorless	Should be clear (for injection, hemodialysis) or no thicker than No.2 turbidity standard solution (for oral use)
Chloridate		Not thicker(0.015%)	Not thicker[(0.002%(for injection, hemodialysis) or 0.015% (for oral use)]
Sulphate		Not thicker(0.015%)	Not thicker[(0.005%(for injection, hemodialysis) or 0.015% (for oral use)]
Ammonium salt		No deeper(0.002%)	No deeper(0.002%)
Loss on drying		≤0.25%	≤0.23%
Elemental impurity		-	Al≤0.0002%;Cu≤0.0001%;Mg≤0.0002%
Calcium salt		≤0.01%	Not thicker[(0.01%(for injection, hemodialysis)]
Molysite		≤0.002%	Not thicker[(0.0005%(for injection, hemodialysis) or 0.0015%(for oral use)]
Heavy metal	PPM	-	≤5
Arsenic salt		-	Comply with the regulation
Bacterial endotoxin		-	<20EU/g
Microbial limit		Total aerobic microbial count≤800cfu/g, Total yeasts and molds≤80cfu/g, Escherichia coli should not be detected (for oral use)	Total aerobic microbial count≤80cfu/g, Total yeasts and molds≤10cfu/g, Escherichia coli should not be detected (for injection)
Content		NaHCO3 content should be 99.5 - 100.5%	NaHCO3 content should be 99.0% - 101.0% (for injection, hemodialysis) or no more than 99.0% (for oral use)

 

Packaging & Shipping

Packed  in PP bags as 25kg or depend on customer requirement

Strictly Deliver the goods in accodance with the contract.

Stored in a cool, ventilated warehouse. Keep away from fire and heat. Should be stored with acids, etc., Mixed storage is forbidden. The reservoir shall be provided with suitable materials for the leakage. Loading should be safe. During transportation;During transportation, it can not be exposed to insolation, rain, high temperature.
 

Company Profile

Weifang Xinchang Chemical Co., Ltd, a limited liability company which is engaged in production and trade in accordance with modern enterprise management system.

Main Business
The products mainly operated by the company include bulk phar maceutical chemicals such as sodium bicarbonate, cyclodextrin series (such as sodium sulfobutyl ether beta-cyclodextrin, hydroxypropyl beta-cyclodextrin, etc.), phar maceutical excipients and phar maceutical intermediates.
Among them, the sodium bicarbonate product is produced by using the new patented equipment independently developed by the company, which has successfully overcome the technical barriers for large-particle sodium bicarbonate. The product is divided into two grades, namely bulk phar maceutical chemical grade and phar maceutical excipient grade, and is widely applicable to various medical fields such as oral administration, injection, and hemodialysis.
Competitive Products
Sodium bicarbonate: Produced by using new patented equipment, it is of excellent quality and is divided into bulk phar maceutical chemical grade and phar maceutical excipient grade. It can be used for oral administration, injection and hemodialysis, meeting various medical needs.
Sodium sulfobutyl ether beta-cyclodextrin: It is the first product registered as a phar maceutical excipient in China, filling the gap in the domestic market. Its registration number for phar maceutical excipients on the CDE (Center for Drug Evaluation) platform is F20180000620, and its registration number for filing with the US FDA (Food and Drug Administration) is DMF 29394, reaching an international leading level.
Hydroxypropyl beta-cyclodextrin: The product has multiple specifications and uses and has been widely used and recognized in both domestic and foreign markets. Its registration numbers for phar maceutical excipients on the CDE platform include F20209990335 (for oral administration, Status A, Approval Number of Shandong Phar maceutical Products: F2012004), F20180000146 (for oral administration), F20180000895 (for injection), and its registration number for filing with the US FDA is DMF 033403.
Customized R&D and Sales Support
The company has a professional R&D team that can undertake customized R&D projects for phar maceutical intermediates to meet the individualized needs of customers. Meanwhile, the company also has an experienced sales team and a technical support department that can provide customers with all-round and high-efficiency services.

 

FAQ

 

Q: Are you a trade company or factory? 
A: We are a chemical factory with our own trading company.

Q: How long time you can make the shipping? 
A: We can make the shipping within 15 days after confirming the order. 

Q: Where is your factory located? How can I visit the factory? 
A: Our factory located in WEIFANG, China. It is only two hours from QINGDAO.