山东久隆恒信药业有限公司

SHANDONG JIULONG HISINCE PHARMACEUTICAL CO.,LTD

分析报告单
Certificate of Analysis
Product name Carbasalate Calcium

Lot No． 202405006

Quantity 1500KG

MFG Date MAY .11, 2024

Date of analysis MAY .13, 2024

EXP Date MAY .10, 2026

Analysis Test Specification Result

White crystalline
Description White or almost white crystalline powder
powder
Freely soluble in water and in dimethylformamide
Solubility practically insoluble in acetone and anhydrous Conforms
methanol
1. Max. absorption under 228nm and 276nm,
Conforms
coefficient respectively are:363-379 and 49-53.
2.IR: Conforms to the reference spectra Conforms
3.The color become Y. or B.Y when it with
Identification sodium hydroxide heating, steam make the litmus Conforms
paper become bule
4.Should show salicylic acid salt to identify
Conforms
reaction
5.Should show calcium salt to identify reaction Conforms
The solution is not more opalescent
Appearance of solution Conforms
than reference suspension II and is colourless
Sodium ≤0.1% 0.02%

Impurity C≤0.5% 0.25%

Related substances Impurity B≤0.15% ND

Unspecified impurities≤0.05% 0.02%
Total≤0.7% 0.3%
Water ≤0.1% 0.07%

Assay 99.0-101.0%(on the anhydrous substance) 99.6%

Conclusion：Complies with the EP10.0 standard

Chief of Q.A.Dep.： Reinspector： Analyst：

Add:Huadian Pioneer Park, Huadian Township, Qinhe, Dezhou, Shandong, China

Tel: +86-534-8997167 FAX: +86-534-8997168
www.jiulongsd.com