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PHR3314

Drospirenone

certified reference material, pharmaceutical secondary standard

Synonym(s):

6β,7β:15β,16β -Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone, Dihydrospirorenone

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About This Item

Empirical Formula (Hill Notation):
C24H30O3
CAS Number:
67392-87-4
Molecular Weight:
366.49
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD00867350
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001105, traceable to USP 1229409

packaging

pkg of 500 mg

application(s)

pharmaceutical small molecule

storage temp.

2-30°C

SMILES string

C[C@]12CCC(=O)C=C1[C@@H]3C[C@@H]3[C@@H]4[C@@H]2CC[C@@]5(C)[C@H]4[C@@H]6C[C@@H]6[C@@]57CCC(=O)O7

InChI

1S/C24H30O3/c1-22-6-3-12(25)9-17(22)13-10-14(13)20-16(22)4-7-23(2)21(20)15-11-18(15)24(23)8-5-19(26)27-24/h9,13-16,18,20-21H,3-8,10-11H2,1-2H3/t13-,14+,15-,16+,18+,20-,21+,22-,23+,24+/m1/s1

InChI key

METQSPRSQINEEU-HXCATZOESA-N

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

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.

Biochem/physiol Actions

Drospirenone is a fourth-generation progestin that has antimineralocorticoid, and antiandrogenic activity in addition to potent progestogenic activity. In two recent studies drospirenone appeared to double the risk of venous thromboembolism compared to levonorgestrel, although other studies found little added risk.
Fourth-generation progestin; contraceptive

Analysis Note

These secondary standards offer multi-traceability to the USP and EP 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 LRAA6959(changes by product) in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Health hazard
GHS08

signalword

Danger

hcodes

H360

Hazard Classifications

Repr. 1B

Storage Class

6.1D - Non-combustible acute toxic Cat.3 / toxic hazardous materials or hazardous materials 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

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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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Articles

Drospirenone Assay: USP Monograph

HPLC method determines Drospirenone in progestin medication using Purospher® STAR RP-18e Hibar® HPLC column, meeting USP monograph criteria.

Global Trade Item Number

SKUGTIN
PHR3314-500MG04065267402543