Product Name: Calcium Dobesilate Monohydrate

Expiry date: 3 Years

Items

Specifications

Results

Appearance

White or almost white powder

White powder

Identification

Absorption maxima: At 221 nm and 301 nm. Specific absorbance at the absorption maximum at 301 nm: 174 to 181.

Complies

A blue color and a precipitate are immediately produced.

Complies

Gives reaction (b) of calcium.

Complies

Appearance of solution

Clear and colorless

Clear and colorless

pH

4.5 to 6.0

4.8

Related substances

Impurity A: NMT 0.1%

0.012%

Unspecified impurities: NMT 0.10%

0.016%

Total: NMT 0.2%

0.025%

Iron

NMT 10ppm

Complies

Residual solvents

Ethanol: NMT 0.5%

Not detected

Acetone: NMT0.5%

Not detected

Water

4.0% to 6.0%

4.3%

Assay

99.0% to 101.0% (anhydrous substance)

99.9%

Microbial limit

Aerobe: NMT 103cfu/g

Complies

Molds and yeast: NMT 102cfu/g

Complies

Conclusion

The product is tested by BP 2018 and quality standard of calcium Dobesilate monohydrate