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PHR1043

Supelco

Prednisolone

Pharmaceutical Secondary Standard; Certified Reference Material

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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
PubChem Substance ID:
329823073
NACRES:
NA.24

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)

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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.

related product

Product No.
Description
Pricing

P2700000

Prednisolone, European Pharmacopoeia (EP) Reference Standard

P2800000

Prednisolone acetate, European Pharmacopoeia (EP) Reference Standard

P2810000

Prednisolone sodium phosphate, European Pharmacopoeia (EP) Reference Standard

Y0001355

Prednisolone for system suitability, European Pharmacopoeia (EP) Reference Standard

Y0001359

Prednisolone for peak identification, European Pharmacopoeia (EP) Reference Standard

P2805000

Prednisolone pivalate, European Pharmacopoeia (EP) Reference Standard

Y0000582

Prednisolone acetate for peak identification, European Pharmacopoeia (EP) Reference Standard

1557000

Prednisolone sodium phosphate, United States Pharmacopeia (USP) Reference Standard

1555005

Prednisolone, United States Pharmacopeia (USP) Reference Standard

1556008

Prednisolone acetate, United States Pharmacopeia (USP) Reference Standard

1556507

Prednisolone hemisuccinate, United States Pharmacopeia (USP) Reference Standard

1558003

Prednisolone tebutate, United States Pharmacopeia (USP) Reference Standard

BP464

Prednisolone, British Pharmacopoeia (BP) Assay Standard

BP292

Prednisolone sodium phosphate, British Pharmacopoeia (BP) Assay Standard

PHR1630

Prednisolone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

BP1140

Prednisolone acetate, British Pharmacopoeia (BP) Reference Standard

PHR2556

Prednisolone Impurity H, Pharmaceutical Secondary Standard; Certified Reference Material, certified reference material, pharmaceutical secondary standard

PHR2557

Prednisolone Impurity I, certified reference material, pharmaceutical secondary standard

PHR2328

Prednisolone Impurity G, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2816

Prednisolone Sodium Phosphate, certified reference material, pharmaceutical secondary standard

Pictograms

Health hazard
GHS08

Signal Word

Danger

Hazard Statements

H360FD

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

Regulatory Information

监管及禁止进口产品

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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)
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)
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)
J A P Spijkers-Hagelstein et al.
Leukemia, 28(4), 761-769 (2013-08-21)
Successful treatment results for MLL-rearranged Acute Lymphoblastic Leukemia (ALL) in infants remain difficult to achieve. Significantly contributing to therapy failure is poor response to glucocorticoids (GCs), like prednisone. Thus, overcoming resistance to these drugs may be a crucial step towards
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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