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Pharmaceutical Secondary Standard; Certified Reference Material

2,3-Dihydroxy-1,2-benzisothiazol-3-one-1,1-dioxide, o-Benzoic sulfimide, 2-Sulfobenzoic acid imide, Saccharin
Empirical Formula (Hill Notation):
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard




current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


226-229 °C (lit.)

Featured Industry

Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to PhEur S0040000
traceable to USP 1607007

SMILES string




InChI key


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General description

Saccharin is a well-known non-carbohydrate, sulfonyl amide artificial sweetener and is generally used in the form of its calcium or sodium salt. It possesses a sweetening power of about 550 times more than that of saccharose. On losing the acidic imino hydrogen, it forms the corresponding nitro anion, which exhibits interesting coordination chemistry. It offers a bitter and metallic aftertaste which limits its use as an artificial sweetening agent.
Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary 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.
Saccharin can be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatographic and spectrophotometric techniques.

Biochem/physiol Actions

A sweet tastant for mammals. A glycerol taste receptor binding site specific for glucose has been proposed in drosophila.

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 LRAC3561 in the slot below. This is an example certificate only and may not be the lot that you receive.

Storage Class Code

13 - Non Combustible Solids

WGK Germany


Flash Point F

Not applicable

Flash Point C

Not applicable

Certificate of Analysis

Certificate of Origin

Metal complexes of saccharin
Baran EJ and Yilmaz VT
Coordination Chemistry Reviews, 250(15-16), 1980-1999 (2006)
Saccharin analysis in pharmaceutical and cosmetic preparations by derivative ultraviolet spectrophotometry
Vianna-Soares CD and Martins JLS
Brazilian Journal of Pharmaceutical Sciences, 38(4), 471-478 (2002)
HPLC analysis of aspartame and saccharin in pharmaceutical and dietary formulations.
Di Pietra AM, et al.
Chromatographia, 30(3-4), 215-219 (1990)
Bitter taste receptors for saccharin and acesulfame K
Kuhn C, et al.
The Journal of Neuroscience, 24(45), 10260-10265 (2004)
J Whysner et al.
Pharmacology & therapeutics, 71(1-2), 225-252 (1996-01-01)
Sodium saccharin (NaSac) produces bladder tumors consistently in male rats only after lifetime exposure that begins at birth. NaSac is not metabolized and is negative in most genotoxicity tests. NaSac-induced cell damage and proliferation have been proposed as important factors...

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