Specification No. X05

Xylazine hydrochloride

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

Molecular Formula: C₁₂H₁₇ClN₂S
Molecular Weight: 256.79
C.A.S. No.: [23076-35-9]

Description: White or almost white, crystalline, hygroscopic powder.

Tests:	Limits:	Methods:
Identification:  a) I.R. spectrum b) It gives reaction of chlorides		Ph. Eur. 5 th Ed. 2005, <2.2.24> Ph. Eur. 4th Ed. 2005, <2.3.1>
Appearance of solution:	Not more opalescent than reference suspension II	Ph. Eur. 5 th Ed. 2005, <2.2.1>
Color of 10% (w/v) aqueous solution:	colorless	Ph. Eur. 5 th Ed. 2005, <2.2.1>
pH of 5 % (w/v) aqueous solution	4.0 - 5.5	Ph. Eur. 5th Ed., <2.2.3>
Impurity A: Related substances (HPLC): • Impurity B: • Impurity C: • Impurity D: Any other individual impurity (HPLC): Total of impurities other then B,C,D,E (HPLC):	max.100 ppm max. 0,2% max. 0,2% max. 0,2% max. 0,2% max. 0,2%	Ph. Eur. 5 thEd. 2005, page 2716 Ph. Eur. 5 th Ed. 2005, <2.2.29> Ph. Eur. 5 thEd. 2005, page 2716 Ph. Eur. 5 thEd. 2005, page 2716 Ph. Eur. 5 thEd. 2005, page 2716 Ph. Eur. 5 thEd. 2005, page 2716 Ph. Eur. 5 thEd. 2005, page 2716
Loss on drying (105 °C, 2h):	max. 0.5 %	Ph. Eur. 5 th Ed., <2.2.32>
Heavy metals:	max. 10 ppm	Ph. Eur. 5 th Ed., <2.4.8>
Sulphated ash:	max. 0.1 %	Ph. Eur. 5th Ed., <2.4.14>
Assay (Alkalimetric titration, calculation based on dry substance): Ethanol (GC): Diethylether (GC):	98.0 - 102.0 % max. 2500 ppm max. 2500 ppm	Ph. Eur. 5 th Ed., page 2717 Ph. Eur. 5 thEd. 2005, <2.2.28> NQ X05, test No. 14 Ph. Eur. 5 thEd. 2005, <2.2.28> NQ X05, test No. 15
Microbiological test:
Bacteria	max. 10 000 cfu/g	Ph. Eur. 5 thEd. 2005, <2.6.12>
Fungi	max. 100 cfu/g	Ph. Eur. 5 thEd. 2005, <2.6.12>
Enterobacteria	max. 100 cfu/g	Ph. Eur. 5 thEd. 2005, <2.6.12>
Escherichia coli in 1g	absent	Ph. Eur. 5 thEd. 2005, <2.6.12>
Salmonella in 10 g	absent	Ph. Eur. 5 thEd. 2005, <2.6.12>
Pseudomonas aeruginosa in 1g	absent	Ph. Eur. 5 thEd. 2005, <2.6.12>
Staphylococcus aureus in 1g	absent	Ph. Eur. 5 thEd. 2005, <2.6.12>
Impurity A: 2,6 –dimethylaniline Impurity B: N,N´-bis(2,6-dimethylphenyl)thiourea Impurity C: 2,6-dimethylphenylisothiocyanate Impurity D: N-(2,6-dimethylphenyl)-N´-(3-hydroxypropyl)thiourea Impurity E: methyl (2,6-dimethylphenyl)carbamodithioate *NQ = Norm of Quality
Shelf life: 1 year

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