Pharmaceutical Injection Grade Sodium Chloride saline solution

Product Description
Sodium Chloride contains not less than 99.0% and not more than 100.5%of sodium chloride (NaCl), calculated on the dried basis.
Labeling—Where Sodium Chloride is intended for use in the manufacture of injectable dosage forms, peritoneal dialysis solutions, hemodialysis solutions, or hemofiltration solutions, it is so labeled. Where Sodium Chloride must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of Bacterial endotoxins, it is so labeled. Where Sodium Chloride is sterile, it is so labeled.
Detailed Images
Identification reaction of sodium chloride (NaCl)
Sodium chloride show show positive reation for sodium.
Sodium chloride show show positive reation for chloride.
Other test item and Assay reference as BP USP
Stability test:
In order to demonstrate stability of finished pharmaceutical product, we has initiated a stability program with sodium chloride which is in accordance with the Note for Guidance on Stability Testing: ICH Q1 Stability.
The stability study has been designed in accordance with the requirements of the Note for Guidance mentioned above.
The storage conditions as follows: Accelerated stability studyLong-term stability study
Temperature: 40℃±2℃
Relative humidity: 75%±5%
Temperature: 30℃±2℃
Relative humidity:70%±5%
Test Equipment:humidity and temperature stability testing chamber
Related Products
Except pharmaceutical grade sodium chloride,we have other APIs and test instrument ,pls more detail,please go through our web.
Manufacture and QA
Manufacture principal of sodium chloride:
(i) preparing a brine having a sodium chloride concentration which is higher than the sodium chloride concentration of the eutectic point but lower than the sodium chloride concentration of a saturated brine by dissolving a sodium chloride source in water;
(ii) cooling the resulting brine by indirect cooling in a self-cleaning fluidized bed heat exchanger/crystallizer to a temperature lower than 0centigrade but higher than the eutectic temperature of the resulting brine, thereby forming a slurry comprising sodium chloride dihydrate and a mother liquor;
(iii) feeding the sodium chloride dihydrate to a recrystallizer to form sodium chloride and a mother liquor, and (iv) recycling at least part of the mother liquor obtained in step (ii) and/or step (iii) to step (i).
Key control point of sodium chloride:
Distribution ratios of impurities for the sodium chloride formation (step iv) were determined according to the following procedure. Water was evaporated from raw brine at 30° C. and reduced pressure until a concentration factor of 1.3 was reached. The sodium chloride crystals formed were separated from the mother liquor by filtration at ambient temperature. Sodium chloride crystals were washed amply with a saturated, ultra-pure sodium chloride solution (i.e. pharma grade sodium chloride dissolved in demineralized water) to prevent crystals from dissolving.
Quality control of sodium chloride:
Multiple-effect evaporators are energy-intensive because of the water evaporation step involved. Furthermore, brine produced by dissolving a natural sodium chloride source in water normally contains a quantity of major contaminations. Said contaminations in brine obtained from a natural source comprise in al. potassium, bromide, magnesium, calcium, strontium, and sulphate ions. For many applications, such as in the chemical transformation industry (e.g. the chlorine and chlorate industry), where the used equipment is extremely sensitive, these contaminations have to be removed to a large extent.
Our Services
We have a full range of in-depth cooperation with many key professional engineers in the pharmaceutical, dialysis industry for production, equipment and quality. We have strong technical support, professional knowledge and a team to integrate China's resources to provide a full range of services for the pharmaceutical and dialysis industries to customers with different requirements.
Packaging & Shipping
FAQ
1. Q: Are you a Trading Company or manufacturer?
A:We are not a pure trading company, bcoz we have our own invested factories.
2. Q: Are you a legal factory which approved by china FDA?
A: Yes, we have a legal factory register at china FDA. We also sell HD products at china domestic market.
3. Q: Can you provide free samples and how long?
A: Yes, we can offer some free samples for analysis while the freight cost shall be burden by buyer. When you have PO, we can return back the freight fee.
4. Q: Can you offer OEM services?
A:Yes, we can provide full OEM services.
5. Q: Can you provide dossiers for register at MOH services?
A:Yes, we can provide dossiers,FSC and other documents for working together to. finish register.
6. Q: Do you have after-sales services:
A:Yes, we must responsible for our delivered products in the valid time of products.
7. Q: Can we be your exclusive distributor in my country?
A:We are looking for distributor in different countries, if you are interested in this. issue, we could discuss it face to face.