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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

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About This Item

Empirical Formula (Hill Notation):
C21H28O5
CAS Number:
50-24-8
Molecular Weight:
360.44
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823073
EC Number:
200-021-7
Beilstein/REAXYS Number:
1354103
MDL number:
MFCD00003649

Key Documents

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Product Name

Prednisolone, Pharmaceutical Secondary Standard; Certified Reference Material

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

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

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. P2700000
traceable to USP 1555005

API family

prednisolone

CofA

current certificate can be downloaded

Quality Level

300

Gene Information

human ... NR3C1(2908)

packaging

pkg of 500 mg

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

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Analysis Note

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

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.

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.

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.
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.

pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H360FD

Hazard Classifications

Repr. 1B

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 2

Regulatory Information

监管及禁止进口产品
This item has

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Development and validation of spectrophotometric and HPLC method for the simultaneous estimation of salbutamol sulphate and prednisolone in tablet dosage form
Chitlange SS, et al.
Journal of Analytical and Bioanalytical Techniques , 2(117), 2-2 (2011)
Quantitative determination of captopril and prednisolone in tablets by FT-Raman spectroscopy
Mazurek S and Szostak R
Journal of Pharmaceutical and Biomedical Analysis, 40(5), 1225-1230 (2006)
Separation of serum prednisolone and prednisolone-21-hemisuccinate by extraction and their concurrent determination by radioimmunoassay
Yanaglbashl, K, et al.
Clinical Chemistry, 26(9), 1301-1303 (1980)
Vappu Rantalaiho et al.
Annals of the rheumatic diseases, 73(11), 1954-1961 (2013-08-03)
To study whether adding initial infliximab to remission-targeted initial combination-DMARD treatment improves the long-term outcomes in patients with early rheumatoid arthritis (RA). Ninety-nine patients with early, DMARD-naïve RA were treated with a triple combination of DMARDs, starting with methotrexate (max
Axel Heidenreich et al.
European journal of cancer (Oxford, England : 1990), 50(6), 1090-1099 (2014-02-04)
Cabazitaxel/prednisone has been shown to prolong survival versus mitoxantrone/prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or after docetaxel. Subsequently, compassionate-use programmes (CUPs) and expanded-access programmes (EAPs) were established worldwide, allowing access to cabazitaxel before
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