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PHR1014

Hydrocortisone

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

11β,17α,21-Trihydroxypregn-4-ene-3,20-dione, 17-Hydroxycorticosterone, 4-Pregnene-11β,17α,21-triol-3,20-dione, Cortisol, Kendall’s compound F, Reichstein’s substance M

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About This Item

Empirical Formula (Hill Notation):
C21H30O5
CAS Number:
Molecular Weight:
362.46
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
EC Number:
200-020-1
Beilstein/REAXYS Number:
1354819
MDL number:
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Quality Level

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. H1300000, traceable to USP 1316004

API family

hydrocortisone

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

211-214 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

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)CO

InChI

1S/C21H30O5/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/h9,14-16,18,22,24,26H,3-8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1

InChI key

JYGXADMDTFJGBT-VWUMJDOOSA-N

Gene Information

human ... NR3C1(2908)

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 is a degradation product of the corticosteroid, hydrocortisone acetate.

Application

Hydrocortisone may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various 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.

Biochem/physiol Actions

Primary glucocorticoid secreted by the adrenal cortex.
Primary glucocorticoid secreted by the adrenal cortex. It has three times the anti-inflammatory potency of corticosterone but much lower Na2+ retention potency.
Primary glucocorticoid secreted by the adrenal cortex. It has three times the anti-inflammatory potency of corticosterone but much lower Na2+ retention potency.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.
To see an example of a Certificate of Analysis for this material enter LRAB3713 in the slot below. This is an example certificate only and may not be the lot that you receive.

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This Item
H1300000Y0001092H3160
technique(s)

HPLC: suitable, gas chromatography (GC): suitable

technique(s)

-

technique(s)

-

technique(s)

-

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

application(s)

pharmaceutical (small molecule)

format

neat

format

neat

format

neat

format

-

Quality Level

300

Quality Level

-

Quality Level

-

Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

grade

pharmaceutical primary standard

grade

pharmaceutical primary standard

grade

-

storage temp.

2-30°C

storage temp.

2-8°C

storage temp.

2-8°C

storage temp.

-


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pictograms

Health hazard

signalword

Danger

Hazard Classifications

Repr. 1A - STOT RE 2

target_organs

Adrenal gland,Bone marrow

Storage Class

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

flash_point_f

Not applicable

flash_point_c

Not applicable



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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Simultaneous determination of hydrocortisone and benzyl alcohol in pharmaceutical formulations by reversed-phase high-pressure liquid chromatography.
Rego Aand Nelson B
Journal of Pharmaceutical Sciences, 71(11), 1219-1223 (1982)
On-line post-column photochemical derivatization in liquid chromatographic− diode-array detection analysis of binary drug mixtures.
Di Pietra AM,et al
Journal of Pharmaceutical and Biomedical Analysis, 14(8-10), 1191-1199 (1996)
Advantages of application of UPLC in pharmaceutical analysis.
Novakova L, et al.
Talanta, 68(3), 908-918 (2006)



Global Trade Item Number

SKUGTIN
PHR1014-500MG04061835236886

Questions

1–2 of 2 Questions  
  1. How can I determine the shelf life / expiration / retest date of this product?

    1 answer
    1. If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
      For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
      For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
      For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf

      Helpful?

  2. How is shipping temperature determined? And how is it related to the product storage temperature?

    1 answer
    1. Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf

      Helpful?

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