PHR1630

Prednisolone Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Prednisolone 21-acetate, 1,4-Pregnadiene-11β,17α,21-triol-3,20-dione 21-acetate, 11β,17α,21-Trihydroxy-1,4-pregnadiene-3,20-dione 21-acetate, 21-Acetoxy-1,4-pregnadiene-11β,17α-diol-3,20-dione
• Empirical Formula (Hill Notation): C₂₃H₃₀O₆
• CAS Number: 52-21-1
• Molecular Weight: 402.48
• Beilstein/REAXYS Number: 3111798
• EC Number: 200-134-1
• MDL number: MFCD00037710
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823520
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 1140; traceable to Ph. Eur. P2800000; traceable to USP 1556008
• API family: prednisolone
• CofA: current certificate can be downloaded
• packaging: pkg of 1 g
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1([H])[C@@H](O)C[C@@]4(C)[C@@]2([H])CC[C@]4(O)C(=O)COC(C)=O
• InChI: 1S/C23H30O6/c1-13(24)29-12-19(27)23(28)9-7-17-16-5-4-14-10-15(25)6-8-21(14,2)20(16)18(26)11-22(17,23)3/h6,8,10,16-18,20,26,28H,4-5,7,9,11-12H2,1-3H3/t16-,17-,18-,20+,21-,22-,23-/m0/s1
• InChI key: LRJOMUJRLNCICJ-JZYPGELDSA-N
• Gene Information: human ... NR3C1(2908)

Description

General description

Certified 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 Acetate belongs to the group of glucocorticoids, widely used to treat allergic and inflammatory conditions of the eyes.

Application

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. Prednisolone Acetate may be used as a secondary pharma standard for the determination of the analyte in pharmaceutical formulations using high-performance liquid chromatography technique.

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 LRAC0028 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• pictograms: GHS08
• signalword: Danger
• hcodes: H360FD
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 1B
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3