利福平

TESTS

SPECIFICATIONS

RESULTS

Characteristics

Reddish brown crystalline powder, odorless and tasteless

Conforms

Identification

Should meet the requirement

Conforms

Solubility

Freely soluble in chloroform, soluble in ethyl acetate and methanol, very slightly soluble in water

Conforms

Crystallinity

Should meet the requirement

Conforms

pH value

4.5~6.5

5.7

Loss on drying

≤2.0%

0.4%

Related substances

Rifampicin quinone ≤1.5%

0.14%

Any other individual impurity ≤1.0%

0.74%

Total impurities ≤3.5%

2.13%

Residual solvents

n-Butanol ≤5000ppm

Conforms

DMF ≤880ppm

Microbial limit

Aerobe amount ≤1000cfu/g

Conforms

Mould and yeast ≤100cfu/g

E.coli: every 1g shall not be detected

Assay

95.0%~103.0% (on dried basis)

98.4%

Conclusion

The product complies with the standard of USP42.

Remarks

Density: 0.58g/cm³