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PHR1589

Medroxyprogesterone Acetate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Medroxyprogesterone 17-acetate, 17α-Acetoxy-6α-methylprogesterone, 17α-Hydroxy-6α-methyl-4-pregnene-3,20-dione 17-acetate, 6α-Methyl-17α-acetoxyprogesterone, 6α-Methyl-17α-hydroxyprogesterone acetate

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About This Item

Empirical Formula (Hill Notation):
C24H34O4
CAS Number:
71-58-9
Molecular Weight:
386.52
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823495
EC Number:
200-757-9
Beilstein/REAXYS Number:
2066112
MDL number:
MFCD00010483

Key Documents

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InChI key

PSGAAPLEWMOORI-PEINSRQWSA-N

InChI

1S/C24H34O4/c1-14-12-18-19(22(4)9-6-17(27)13-21(14)22)7-10-23(5)20(18)8-11-24(23,15(2)25)28-16(3)26/h13-14,18-20H,6-12H2,1-5H3/t14-,18+,19-,20-,22+,23-,24-/m0/s1

SMILES string

[H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]4(C)[C@@]2([H])CC[C@]4(OC(C)=O)C(C)=O

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. M0250000, traceable to USP 1378001

API family

medroxyprogesterone

CofA

current certificate can be downloaded

packaging

ampule of 500 mg

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

mp

206-207 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Quality Level

300

Gene Information

human ... PGR(5241)

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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. Medroxyprogesterone acetate is a synthetic progestational drug utilized as a contraceptive. It is also used as a medication for the treatment of hormone-dependent cancers, such as breast cancer.

Application

Medroxyprogesterone Acetate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical suspensions, bulk drug and tablet formulations by Raman spectroscopy and 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.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
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 LRAC2690 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Health hazard
GHS08

signalword

Warning

hcodes

H351,H413

Hazard Classifications

Aquatic Chronic 4 - Carc. 2

Storage Class

11 - Combustible Solids

wgk

WGK 3

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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Development and validation of a reversed-phase liquid chromatographic method for analysis of estradiol valerate and medroxyprogesterone acetate in a tablet formulation
Segall A, et al.
Journal of Pharmaceutical and Biomedical Analysis, 19(5), 803-808 (1999)
Raman spectroscopic method for the determination of medroxyprogesterone acetate in a pharmaceutical suspension: validation of quantifying abilities, uncertainty assessment and comparison with the high performance liquid chromatography reference method
De Beer TRM, et al.
Analytica Chimica Acta, 589(2), 192-199 (2007)
Simultaneous determination of estradiol valerate and medroxyprogesterone acetate in a tablet formulation by gas chromatography-mass spectrometry
Yilmaz B
Analytical Sciences, 26(3), 391-393 (2010)
Medroxyprogesterone Acetate
USP42-NF37
United States Pharmacopeia/National Formulary, 29(5), 2707-2707 (2013)
A stability-indicating HPLC method for medroxyprogesterone acetate in bulk drug and injection formulation
Burana-osot J, et al.
Journal of Pharmaceutical and Biomedical Analysis, 40(5), 1068-1072 (2006)

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