Bacterial Endotoxins Tranexamic Acid CAS No 1197-18-8

• Function: Hemostatic
• Certification: GMP
• Grade Standard: Medicine Grade
• Type: Chemical Reagent
• State: Powder
• Volatile: Not Volatile
• Model NO.: SAMREAL-0348
• Standard: Bp,Ep
• Transport Package: Drum
• Specification: 25kg/drum
• Trademark: samreal
• Origin: China

Product Description

Tranexamic acid cas no 1197-18-8

Test	Specification	Result
Description	White or almost white,crystalline powder.	conforms
Solubility	Freely soluble in water and in glacial acetic acid,practically insoluble in acetone and in ethanol(96 per cent)	conforms
Identification	The infrared absorption spectrum of substancemust meet the absorption	conforms
pH	7.0-8.0	7.5
Related substances	Impurity A:NMT 0.1%	Not found
	Impurity B:NMT 0.2%	0.06%
	Unspecified impurities:NMT0.1%	Not found
	Sum of unspecified impurities:NMT 0.2%	0.05%
Halides expressed as chlorides	NMT 140ppm	conforms
Heavy Metals	NMT 10ppm	conforms
Sulphated ash	NMT0.1%	conforms
Loss on drying	NMT0.5%	0.2%
Residual solvents	No organic solvent was used	conforms
Bacterial endotoxins	Less than 0.1 IU/mg	conforms
Microbiologieal purity	TAMC-not more than 1000 cfu/g	<10cfu/g
	TYMC-not more than 100 cfu/g	<10cfu/g
	E.coli-be absent	Not detected
Assay	99.0%~101.0%(calculated on the dried basis)	99.4%
Conclusion	The test results conform to EP9.0 Specifications

 

Tests Carried Out	Limits	Observations
Characteristics	White or almost white crystalline powder	white crystalline powder
Identification	Infrared absorption spectrophotometry(2.2.24) IR spectrum is in concordance with Tranexamic acid CRS	Consistent with the standard
Solubility	Easy to dissolve in the water and the glacial acetic acid, difficult to dissolve in the acetone and the ethyl alcohol	Consistent with the standard
PH	7.0-8.0	7.5
Chloride	≤140ppm	<140ppm
Sulfated ash	≤0.1%	0.02%
Heavy Metals	≤10ppm	<10ppm
Loss on drying	≤0.5%	0.15%
Related substances(HPLC) (2.2.29)	Impurity A: ≤ 0.1%	0.004%
	Impurity B: ≤ 0.2%	0.003%
	Any other impurity : ≤ 0.1%	0.02%
	All other impurity : ≤ 0.2%	0.07%
Content	99.0%--101.0%	99.8%

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