Magnesium Stearate
SIAL/PHR1363 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Magnesium stearate excipient standard
EC Number: 209-150-3
Product Type: Chemical
| API family | magnesium stearate |
| application(s) | pharmaceutical (small molecule) |
| format | neat |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| packaging | ampule of 2.5 g |
| Quality Level | 300  |
| storage temp. | 2-30°C |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available. |
| 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. |
| Application: | 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. |
| 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. |
| 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. |
| 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. |
| Hazard Codes | Xi |
| Risk Statements | 36/37/38 |
| Safety Statements | 26 |
| RIDADR | NONH for all modes of transport |
| WGK Germany | nwg |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-30°C |
| UNSPSC | 41116107 |