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PHR1363

Supelco

Magnesium Stearate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Magnesium stearate excipient standard

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About This Item

Numéro CE :
209-150-3
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

300

Famille d'API

magnesium stearate

Conditionnement

ampule of 2.5 g

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Catégories apparentées

Description générale

Magnesium stearate is commonly utilized as a lubricant in pharmaceutical formulations to avoid the excipient blend from the formulation contents from sticking to the manufacturing equipment.
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

Magnesium stearate may be used as an excipient for the manufacturing of atorvastatin drug and poloxamers. The determination of the analyte in pharmaceutical formulations can be carried out by chromatography and colorimetric methods.
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.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Autres remarques

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.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAA1467 in the slot below. This is an example certificate only and may not be the lot that you receive.

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

nwg

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable

Choose from one of the most recent versions:

Certificats d'analyse (COA)

Lot/Batch Number
LRAD5625
LRAC4318
LRAA1467

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

Analysis of magnesium from magnesium stearate in pharmaceutical tablet formulations using hydrophilic interaction liquid chromatography with nano quantity analyte detection
Risley DS, et al.
Journal of Pharmaceutical and Biomedical Analysis, 78, 112-117 (2013)
Liquid chromatographic determination of atorvastatin in bulk drug, tablets, and human plasma
Altuntas TG and Erk N
Journal of Liquid Chromatography and Related Technologies, 27(1), 83-93 (2004)
Quantitation of poloxamers in pharmaceutical formulations using size exclusion chromatography and colorimetric methods
Mao Y, et al.
Journal of Pharmaceutical and Biomedical Analysis, 35(5), 1127-1142 (2004)

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