Ractopamine hydrochloride/Ractopamine hcl 90274-24-1 CAS NO.90274-24-1

tests

acceptance criteria of sinotech

test result

description

off-white to light yellowish free flowing products

conforms

identification

the retention time of principle peak in the chromatogram of the substance to be examined corresponds to that in the chromatogram of the reference substance

conforms

moisture content by karl ficher

2.5-6.5%

6.2%

bulk density untapped

0.35-0.55g/ml

0.43g/ml

bulk density tapped

0.55-0.75g/ml

0.49g/ml

related substance

any other individual impurity ≤0.1%

total impurities ≤0.5%

0.09%

0.4%

ciprofloxacin content

(on anhydrous basis)

72.0-79.5%

75.5%

dissolution

≥80%(after 30minutes)

89.0%

microbiology

bacterial count ≤1000cfu/mg

fungal count ≤100cfu/mg

escherichia coli: absent

salmonella spp:absent

pesudomonas aeruginosa:absent

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sieve analysia

astm mesh no.

the us std.sieve #40

the us std.sieve #100

%cumulative retention

10-55%

not less than 55%

78.6%

91.8%

conclusion: the product conforms to the above specifications.(sinotech qc)