Specification No. X04

Xylazine base

N-(2,6-Dimethylphenyl)-5,6-dihydro-4H-1,3-thiazin-2-amine

Interpharma

Molecular Formula: C12H16N2S
Molecular Weight: 220.34
C.A.S. No.: [7361-61-7]

Description: White to near white powder.

Tests:
Identification: a) HPLC
b) TLC
Absorbance of 2 % (w/v) aqueous solution measured in 1 cm cell at 400 nm: max. 0.05 %
Heavy metals: max. 0.001 %
Iron:
max. 0.001 %
Chloride: max. 0.1 %
Water (K.F. titration):
max. 0.5 %
Sulphated ash:
max. 0.2 %
Assay (HPLC): min. 99.0 % Area
Assay (Acidimetric titration, calculation based on dry substance): 98.0 - 102.0 %
Microbiological test: Ph. Eur. 5 th Ed., <5.1.4>
Bacteria max. 10 000 cfu/g
Fungi max. 100 cfu/g
Enterobacteria max. 100 cfu/g
Escherichia coli in 1g absent
Salmonella in 10 g absent
Pseudomonas aeruginosa in 1g absent
Staphylococcus aureus in 1g absent
Shelf life: 1 year
INTERPHARMA PRAHA, a.s., Komoranska 955, 143 10 Praha 12, Czech Republic
Business Development: 00420-241 773 242
Secretariat: 00420-241 773 242, Fax: 00420-241 773 235
 
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