PHR1043

Prednisolone

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 1,4-Pregnadiene-11β,17α,21-triol-3,20-dione, 1-Dehydrocortisol, 1-Dehydrohydrocortisone, 11β,17α,21-Trihydroxy-1,4-pregnadiene-3,20-dione
• Empirical Formula (Hill Notation): C₂₁H₂₈O₅
• CAS Number: 50-24-8
• Molecular Weight: 360.44
• Beilstein: 1354103
• EC Number: 200-021-7
• MDL number: MFCD00003649
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823073
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 464; traceable to Ph. Eur. P2700000; traceable to USP 1555005
• API family: prednisolone
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 240 °C (dec.) (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: O=C1C=C[C@@]2(C)C(CC[C@]3([H])[C@]2([H])[C@@H](O)C[C@@]4(C)[C@@]3([H])CC[C@]4(O)C(CO)=O)=C1
• InChI: 1S/C21H28O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h5,7,9,14-16,18,22,24,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1
• InChI key: OIGNJSKKLXVSLS-VWUMJDOOSA-N
• Gene Information: human ... NR3C1(2908)

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.
Prednisolone is a glucocorticoid utilized as an anti-inflammatory or an immunosuppressive drug.

Application

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

Prednisolone may be used as a standard in the separation and determination of prednisolone in serum samples of animals using radioimmunoassay.

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 (PhEur) 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 LRAA6903 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: Danger
• Hazard Statements: H360FD
• Precautionary Statements: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 1B
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 2