Test |
|
Specification |
Description |
: |
White to cream-white, odorless powder. |
Solubility |
: |
Very Slightly soluble in water; very soluble in chloroform; freely soluble in acetone and in alcohol. |
Identification – A |
: |
The Infra red absorption spectrum should be concordant with the spectrum obtained from std of Beclomethasone Dipropionate. |
Specific rotation |
: |
Between + 88.00 and + 94.000. |
Loss on drying |
: |
Not more than 0.50%. |
Residue on ignition |
: |
Not more than 0.100%. |
Residual solvents |
: |
Acetone not more than 5000.00 ppm. |
|
: |
Methylene Chloride not more than 600.00 ppm |
|
: |
Ethyl acetate not more than 5000.00 ppm. |
|
: |
Pyridine not more than 200.00 ppm. |
|
: |
Chloroform not more than 60.00 ppm. |
Assay |
: |
97.00 to 103.00% w.r.t. dried substance
|
*In-house tests |
: |
(As per customer requirement) |
*Microbial limits |
: |
NMT 100 cfu/g |
*Microbial limits |
: |
Absence of Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species. |
*Particle size |
: |
90.00% < 10 micron, 99.00% < 50 micron. |
End of specification |