Myristyl-gamma-picolinium chloride (MGP) is a novel constituent of methylprednisolone acetate suspensions used for intra-articular corticosteroid therapy.
Characters | Unit | Specification |
---|---|---|
Appearance | Off white to pale orange, pink solid | |
Solubility | Soluble in ACN | |
Identification | By NMR | |
Identification - IR | Conforms to Structure | |
Identification - Chlorides
current USP and supplements <191>
Use 20 mg sample in 2 ml of water USP 40 NF 35 |
Respond to Identification Test for Chloride |
|
Residue on ignition current USP and supplements <281> USP 40 NF 36 | Conforms | |
Residual Solvents |
Ethyl Acetate: ≤5000 ppm Acetone: ≤5000 ppm |
|
Water by KF | % | ≤10.0% |
Purity by HPLC | % | ≥98% |
Assay (as - is) | % | 90 - 100% |
pH Use 0.1% w/v Solution in WFI |
3.5 - 7.0 | |
Assay (on anhydrous basis) | % | 98.0 - 102.0% |
Related substances by HPLC (Total Impurities) | % | ≤1.0% |
Chloride content (on anhydrous basis) | % | 10.0 - 11.8% |
Storage/Shipping Conditions:
Pack Sizes: 25 gm