Items

Specifications

Results

Character

White to almost white crystalline powder

Almost white crystalline powder

Identification

1) Complies by IR

Conforms

2) Complies by TLC

Conforms

Specific rotation

+63°to +70°

+67.7°

Related substances

Individual impurity not more than 1.0%

0.04%

Total impurity not more than 2.0%

0.12%

Loss on drying

Not more than 1.0%

0.10%

Residue on drying

Not more than 0.2%

0.08%

Residue solvents

Acetone: not more than 5000ppm

656ppm

Methanol; not more than 3000ppm

104ppm

Chloroform: not more than 60ppm

Undetected

Assay

It should contain 97.0% to 103.0% of C28H37FO7 calculated on dried basis

100.30%

Conclusion

The results can conform with USP35