Pharmaceutical Secondary Standard; Certified Reference Material

Isotretinoin, 13-cis-Retinoic acid
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
EC Number:
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Quality Level


certified reference material
pharmaceutical secondary standard




current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


172-175 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to PhEur I0800000
traceable to USP 1353500

SMILES string




InChI key


Gene Information

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General description

Isotretinoin is a vitamin A derivative, obtained from the isomerization of retinoic acid in the body. It is therapeutically used to treat severe recalcitrant nodular acne. It is also reported to exhibit anti-inflammatory and anti-tumor activities.
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.


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.
Isotretinoin may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography.

Biochem/physiol Actions

13-cis-Retinoic acid (RA) has anti-inflammatory and anti-tumor action. The action of RA is mediated through RAR-β and RAR-α receptors. RA attenuates iNOS expression and activity in cytokine-stimulated murine mesangial cells. It induces mitochondrial membrane permeability transition, observed as swelling and as a decrease in membrane potential, and stimulates the release of cytochrome c implicating mechanisms through the apoptosis pathway. These activities are reversed by EGTA and cyclosporin A. RA also increases MMP-1 protein expression partially via increased transcription.

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.


To see an example of a Certificate of Analysis for this material enter LRAC0144 in the slot below. This is an example certificate only and may not be the lot that you receive.


Exclamation markHealth hazard

Signal Word


Hazard Statements


Eye Irrit. 2 - Repr. 1B - Skin Irrit. 2 - STOT SE 3

Target Organs

Respiratory system


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

WGK Germany


Certificate of Analysis

Certificate of Origin

Determination of isotretinoin in pharmaceutical formulations by reversed-phase HPLC
Guimaraes AC, et al.
Journal of Biomedical Science and Engineering, 3, 454-458 (2010)
Derrick J Stobaugh et al.
Journal of the American Academy of Dermatology, 69(3), 393-398 (2013-05-21)
Some studies have purported to link isotretinoin prescribed for acne with the development of inflammatory bowel disease (IBD). We sought to identify existence of disproportionate attorney-initiated reporting of isotretinoin-associated IBD in the Food and Drug Administration Adverse Event Reporting System...
M Tsukada et al.
The Journal of investigative dermatology, 115(2), 321-327 (2000-08-22)
Despite its potent biologic effect on human sebocytes, 13-cis retinoic acid exhibits low binding affinity for cellular retinoic acid binding proteins and nuclear retinoid receptors. Hence, 13-cis retinoic acid may represent a pro-drug possibly acting through all-trans isomerization. In this...
Mahyar Etminan et al.
JAMA dermatology, 149(2), 216-220 (2013-02-22)
To examine the association between isotretinoin and the risk for inflammatory bowel disease (IBD) among women of reproductive age. Nested case-control study and meta-analysis. A US health claims database. We formed a cohort of women aged 18 to 46 years...
Dimitris Rigopoulos et al.
Clinics in dermatology, 28(1), 24-30 (2010-01-20)
Acne is one of the most prevalent diseases in dermatology: Millions of people worldwide experience this distressing condition. To determine the appropriate therapeutic strategy, there is a strong need for a standardized classification system of acne. The exact molecular mechanism...

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