The product's hydration state is not a tested parameter and is not provided on its certificate of analysis. Handling instructions direct users: "Do not dry, use on an as-is basis."
PHR1363
Magnesium Stearate
Pharmaceutical Secondary Standard; Certified Reference Material
Synonym(s):
Magnesium stearate excipient standard
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About This Item
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grade
certified reference material
pharmaceutical secondary standard
Quality Level
API family
magnesium stearate
packaging
ampule of 2.5 g
application(s)
pharmaceutical (small molecule)
format
neat
storage temp.
2-30°C
General description
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.[1]
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.
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[2] and poloxamers.[3] The determination of the analyte in pharmaceutical formulations can be carried out by chromatography[2] and colorimetric[3] 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.
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.
Footnote
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.
Storage Class Code
11 - Combustible Solids
WGK
nwg
Flash Point(F)
Not applicable
Flash Point(C)
Not applicable
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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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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Hi, is the hydrate state of the Magnesium Stearate product known and certified? Thanks.
1 answer-
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