PHR1718

Methylprednisolone Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-acetate
• Empirical Formula (Hill Notation): C₂₄H₃₂O₆
• CAS Number: 53-36-1
• Molecular Weight: 416.51
• EC Number: 200-171-3
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 249; traceable to Ph. Eur. M1755000; traceable to USP 1436006
• API family: methylprednisolone
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: -10 to -25°C
• InChI: 1S/C24H32O6/c1-13-9-16-17-6-8-24(29,20(28)12-30-14(2)25)23(17,4)11-19(27)21(16)22(3)7-5-15(26)10-18(13)22/h5,7,10,13,16-17,19,21,27,29H,6,8-9,11-12H2,1-4H3/t13-,16-,17-,19-,21+,22-,23-,24-/m0/s1
• InChI key: PLBHSZGDDKCEHR-LFYFAGGJSA-N

Description

General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards. Methylprednisolone is a synthetic corticosteroid drug which is employed for the management of inflammatory diseases. It is used to relieve the inflammations caused by psoriasis, eczema, arthritis, asthma and rhinitis. It is also widely employed for the treatment of acute lung injury caused by acid aspiration.

Application

Methylprednisolone Acetate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA7306 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H361
• Precautionary Statements: P201 - P308 + P313
• Hazard Classifications: Repr. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable