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Safety Information

PHR1363

Supelco

Magnesium Stearate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Magnesium stearate excipient standard

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About This Item

EC Number:
209-150-3
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

API family

magnesium stearate

packaging

ampule of 2.5 g

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

Related Categories

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.
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.

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

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

ISHL Indicated Name

Substances Subject to be Indicated Names

ISHL Notified Names

Substances Subject to be Notified Names

JAN Code

PHR1363-2.5G:
PHR1363-5G:
PHR1363-5G-PW:
PHR1363-2.5G-PW:

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD5625
LRAC4318
LRAA1467

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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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