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Merck
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PHR1606

Hydrocortisone Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Hydrocortisone 21-acetate, 11β,17α,21-Trihydroxy-4-pregnene-3,20-dione 21-acetate, 17-α-Hydroxycorticosterone acetate, 17-Hydroxycorticosterone 21-acetate, 21-Acetoxy-4-pregnene-11β,17α-diol-3,20-dione, 4-Pregnene-11β,17α,21-triol-3,20-dione 21-acetate

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About This Item

Empirical Formula (Hill Notation):
C23H32O6
CAS Number:
50-03-3
Molecular Weight:
404.50
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823503
EC Number:
200-004-4
Beilstein/REAXYS Number:
2066841
MDL number:
MFCD00037714

Key Documents

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Product Name

Hydrocortisone Acetate, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

ALEXXDVDDISNDU-JZYPGELDSA-N

InChI

1S/C23H32O6/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/h10,16-18,20,26,28H,4-9,11-12H2,1-3H3/t16-,17-,18-,20+,21-,22-,23-/m0/s1

SMILES string

[H][C@@]12CCC3=CC(=O)CC[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

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. H1400000
traceable to USP 1317007

API family

hydrocortisone

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

223 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... NR3C1(2908)

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Analysis Note

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

Application

Hydrocortisone Acetate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography and thin layer chromatography techniques.
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.
Hydrocortisone Acetate belongs to the class of corticosteroids, exhibiting antipruritic, anti-inflammatory and vasoconstrictive properties. It is used in the treatment of various conditions such as allergic and breathing disorders or skin conditions.

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 LRAC3177 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

Hazard Classifications

Repr. 1B - STOT RE 2

Storage Class

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

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Information

涉药品监管产品
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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Validation of a thin-layer chromatography for the determination of hydrocortisone acetate and lidocaine in a pharmaceutical preparation
Dolowry M, et al.
TheScientificWorldJournal, 32(4), 921-927 (2014)
Simultaneous determination of methylparaben, propylparaben, hydrocortisone acetate and its degradation products in a topical cream by RP-HPLC
Hajkova R, et al.
Journal of Pharmaceutical and Biomedical Analysis, 32(4), 921-927 (2003)
Simultaneous determination of methylparaben, propylparaben, hydrocortisone acetate and its degradation products in a topical cream by RP-HPLC.
Hajkova R, et al.
Journal of Pharmaceutical and Biomedical Analysis, 32(4-5), 921-927 (2003)

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